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Judith S. Beck, PhD, is president of the Beck Institute for Cognitive Behavior Therapy (CBT) 

, a nonprofit organization that provides state-of-the-art training and CBT certification to individuals and organizations, offers online courses on a variety of CBT topics, conducts research, and serves as a leading global resource for CBT. She is also Clinical Professor of Psychology in Psychiatry at the University of Pennsylvania Perelman School of Medicine. Dr Beck has written over 100 articles and chapters as well as books, workbooks, and pamphlets for professionals and nonprofessionals, including 

Cognitive Behavior Therapy, Third Edition: Basics and Beyond

Cognitive Therapy for Challenging Problems: What to Do When the Basics Don’t Work

. She has made hundreds of presentations nationally and internationally on various applications of CBT and is the primary developer of the Beck Institute’s online CBT training courses, which have been taken by health and mental health professionals in over 130 countries. Dr Beck maintains a clinical caseload at the Beck Institute’s in-house clinic in suburban Philadelphia, helping clients who are experiencing a range of challenges.

: CBT has had its fair share of criticisms over the years, and I have heard that Aaron T. Beck, MD, frequently engaged with (and at times even collaborated with) his critics. Is it accurate to say that your father’s ideas were not initially accepted by the mental health field? Do you think there are meaningful ways in which the field of CBT has benefitted from this engagement with the critics?

 as it was initially called) was not accepted by the psychoanalytic community, though my father’s ideas were favorably viewed among some psychologists, especially behavior therapists. He had originally trained as a psychoanalyst and then recognized that the theoretical constructs of psychoanalysis needed to be validated by research if psychoanalysis was to be accepted by other scientific fields.

At the time, he fully expected that his research would support the basic psychoanalytic tenets of depression. But he found the opposite. Most psychoanalysts rejected this research and later his development of cognitive therapy. More than a decade later, he found he was unable to get his first randomized controlled trial comparing imipramine with cognitive therapy for the treatment of depression published in journals. Initially he was also criticized by some behavior therapists but praised by others who integrated cognitive techniques into treatment. Throughout the years, my father has used valid criticism to refine his theories and treatment. For example, he has added a focus on processes as key agents of change. Depending on the cognitive formulation of the problem or disorder, and the individualized conceptualization of the disorder, he has supported including techniques from other evidence-based treatments. CBT has benefitted from legitimate criticism, and treatment has become more effective because of it.

: There appears to be considerable debate regarding manualized therapy in real-world clinical practice outside of research. Manuals have an understandable role to play in research settings, but to what extent should manuals constrain clinical practice? I might add here that during my own psychiatry residency training, I was taught CBT by a wonderful psychologist who emphasized basic principles of CBT and stressed the importance of developing an individualized CBT formulation to guide treatment, and I sometimes wonder how different that experience would have been if he had relied on manuals instead.

: There are various forms of CBT and to be clear, what I am talking about is the type of CBT developed by my father in the 1960s and 1970s (and refined ever since). At the Beck Institute, we do not use manuals in treatment, and we do not usually endorse the use of manuals outside of research settings. As you mentioned, manuals have a place in clinical trials to ensure that protocol therapists are delivering the same treatment to research subjects. Without manuals, the strong evidence base for CBT would not exist. But in real world settings, patients are complex. For example: they frequently have comorbidities and differ in individual characteristics such as culture, education, developmental level, socioeconomic status, and so on. Good CBT therapists tailor treatment to each individual patient, guided by their cognitive conceptualization, the patient’s presenting problems, strengths, aspirations, and goals for treatment. The treatment plan is developed, and the therapeutic interventions are selected in collaboration with the patient.

: Should CBT in clinical practice be restricted at the outset to a certain number of sessions (say 10-20 sessions) the way it is done in research settings? Or is CBT in clinical practice intended to be more open-ended and goal-dependent? My clinical observation is that when duration of CBT is not individualized and when the number of sessions is capped beforehand (often due to insurance restrictions or administrative reasons), a substantial number of patients are forced to end therapy without having experienced meaningful improvement.

: CBT in clinical practice should not be limited to a certain number of sessions. Many patients with straightforward cases of depression or anxiety can experience significant improvement within 6 to 12 sessions. However, patients with personality disorders, medical conditions, trauma histories, environmental stressors, and other complex conditions usually need a longer course of treatment. Of course, in practice, not all patients are able to complete a longer course of therapy due to monetary or practical constraints.

It is important that therapists understand and make every effort to work within these constraints, by being transparent with patients about their progress and making therapy as efficient as possible. We tell all our patients that it is not enough to come to therapy and talk for 50 minutes a week. The way they get better is to make small changes in their thinking and behavior every day. When therapists and patients finish discussing a problem or goal, therapists ask patients what they want to remember and what they want to do in the coming week. Then therapists motivate them to complete these Action Plans (formerly termed 

) between sessions to maximize the benefits of CBT and prevent relapse without prolonging treatment. Booster sessions, appropriately spaced in the weeks and months following the conclusion of treatment, are an effective way to ensure patient progress is maintained and that patients continue to practice their skills, and cope with new challenges that arise.

: Since the initial development of CBT for depression, we have seen the development of CBTs for a multitude of indications and special populations. Where has CBT been successfully applied over the decades?

: This question has been answered by research. Hofmann and colleagues did a review of meta-analyses a few years ago.

 They found that CBT has been most successfully applied to anxiety disorders, somatoform disorders, bulimia, anger control problems, and general stress. They also noted the efficacy of CBT in the treatment of depression, substance abuse, psychotic disorders, bipolar disorder, insomnia, personality disorders, criminal behaviors, and distress related to medical conditions. While most studies focus on adults, other studies show similar results for children and older adults. In addition, research has established the efficacy of appropriately tailored CBT in a multitude of settings: schools, residential programs, inpatient units, long-term psychiatric hospitals, forensic settings, community-based settings, and primary care and specialty medical clinics, to name a few.

: CBT for psychosis (CBTp) has emerged as a standard recommended treatment for schizophrenia in clinical practice guidelines such as by the National Institute for Health and Care Excellence in the United Kingdom and the American Psychiatric Association in the United States. Despite these recommendations, the availability of and access to CBTp remains limited. What are some of the difficulties that specialized interventions such as CBTp face with regards to dissemination, and what can be done about it?

: One challenge with the dissemination of specialized treatment, perhaps especially one like CBTp, is the lack of availability of individual therapy within different treatment services. While those who are especially help-seeking or those who have the support of family or other loved ones may be able to access a private practice provider, there are many individuals who cannot. In state hospitals, on community teams, in the forensic system, in residences—this is where you see many individuals who are given serious mental health diagnoses. These services often do not have the resources to offer individual therapy. Even if they did, a portion of the individuals are not help-seeking or not interested in a treatment focused on symptoms they do not see as obvious problems.

My understanding is, that as currently practiced, CBTp is primarily conducted by licensed clinicians, the vast majority of whom are psychologists. In the community and hospital settings where most care is delivered, there are many staff from other disciplines where CBTp training is not offered (social workers, licensed counselors, recreational and art therapists, occupational therapists), not to mention nonlicensed and paraprofessional staff such as direct care and peer specialists whose scope of practice does not include CBTp.

Paul Grant, PhD, and my father developed recovery-oriented cognitive therapy (CT-R) to address these limitations.

 While it can be delivered as an individual therapy, CT-R also is a very efficient group approach. It can be the basis for the therapeutic milieu and the basis of treatment planning and team-based work. Licensed and nonlicensed professionals from all disciplines can do it. It is applicable in more settings, especially those that are low-resourced. CT-R uses the cognitive model to understand how individuals get stuck and then employs powerful interventions to engage them and collaborate with them to pursue the life of their choosing.

: The development of CT-R appears to be a productive integration of 2 seemingly quite different traditions, cognitive therapy on one hand, and the recovery movement on the other. What does the recovery model add to the traditional practice of CBT?

: The power of CBT lies in the cognitive model that helps providers understand problems (eg, depression, anxiety, aggressive behavior, hallucinations, delusions, and negative symptoms) in terms of beliefs about the self, others, and the future. CBT includes specific interventions to address maladaptive beliefs and promote adaptive beliefs; it produces continued relief from distress and enables adaptive behavior.

Arthur Evans, PhD, in his previous role as commissioner of the department of behavioral health in Philadelphia, challenged my father and Paul Grant, now the codirector of the Recovery-Oriented Cognitive Therapy Program at Beck Institute, to develop a strong CT-R program for individuals diagnosed with serious mental health conditions who had historically been denied access to evidence-based practice and often languished in institutions. These individuals frequently do not seek help, do not engage in services easily, and can be very distrustful of care providers. The literature shows that they have the poorest outcomes in terms of life expectancy and quality of life.

In CT-R, the first step is to discover the individual behind the problems. Care providers focus less on psychiatric symptoms and more on identifying the life their patient wants to be living. The cognitive model turns out to be a great tool to conceptualize someone’s best self. CBT’s strengths are applied then to the whole individual. The CT-R team at Beck Institute has discovered ways to operationalize recovery principles: connection, trust, hope, purpose, and empowerment. And an age-old observation, that there are times when even the most withdrawn individuals seem more relaxed and connected to others, led to constructing the adaptive mode. This provides the framework for the strategy and interventions of CT-R, in which resilience and empowerment are emphasized. My father is first author on a recent book, 

Recovery-Oriented Cognitive Therapy for Serious Mental Health Conditions

 which shows practitioners how to practice this adaptation. And I have described how to apply CT-R principles to individuals with acute disorders in the third edition of 

Cognitive Behavior Therapy: Basics and Beyond

: How crucial is the therapeutic relationship in the successful practice of CBT? To what extent is the therapeutic benefit of CBT a result of its specific technique vs a result of common factors such as a good therapeutic relationship?

: The therapeutic relationship is paramount in CBT. One common misconception about CBT is that it is cold, rigid, and overly intellectual, and that a strong therapeutic relationship is not required. This could not be further from the truth. Good CBT therapists practice the Rogerian counseling skills of genuineness, warmth, and empathy, and they instill hope by being realistically optimistic about the patient’s situation. This is particularly important because CBT emphasizes collaboration between the patient and the therapist, both on the overarching goals of treatment, and on the issues discussed in session and the specific interventions selected. For the collaboration to be successful, the therapist must convey an accurate understanding of the patient, and the patient must trust the therapist and feel safe. CBT therapists ask for feedback at the end of each session and during the session when they notice a shift in patients’ affect. They respond to negative feedback by praising clients for being open with them. Then they conceptualize the difficulty and collaboratively plan a strategy to correct the problem. The number one rule of the therapeutic relationship, which I tell all of my trainees and psychiatric residents I teach is, “Treat every patient at every session the way you’d like to be treated if you were a patient.”

: Cognitive therapy focuses in part on the identification of cognitive distortions and negative automatic thoughts and schemas as targets of therapeutic change. In recent decades, the role of social and structural factors (such as racial inequalities and poverty) in the development of depression and other psychiatric disorders has also been recognized. There is a common criticism that sees CBT’s emphasis on locating dysfunction internal to the psyche as a way of erasing or ignoring the contributions of social injustice to psychological distress. What are your thoughts on this issue?

: A patient’s cognitive conceptualization must take into account external factors that contributed to the development and maintenance of their disorder. These external factors include family history, socioeconomic status, education level, and racism or discrimination (either experienced or witnessed). Fortunately, there is much more literature and training available now that can help therapists understand the influence of social and economic factors on mental health and the development of disorders such as depression, substance use, and PTSD, among others. Much-needed work is being done by researchers around the world to adapt CBT to different cultures and populations, from different socioeconomic backgrounds, and in different settings. This is an important area for continued research and training.

: I encounter a variety of different attitudes with regards to the psychotherapy traditions, with different therapists having different views on how compatible and complementary these various psychotherapy traditions are, and whether clinicians should align their practice along a single orientation or multiple orientations. What are your views on how the different psychotherapy traditions relate to each other, and what is your advice to therapists with regards to the plurality of psychotherapy orientations?

: In CBT, we incorporate techniques and interventions from other psychotherapeutic modalities, including acceptance and commitment therapy, dialectical behavior therapy, and mindfulness-based approaches, but our cognitive conceptualization of the patient according to the cognitive model always informs the selection of interventions. This is different from practicing eclectically. We follow the evidence and always use the best and most current research to guide our treatment decisions and select interventions.

: Dr Beck is one of the most influential figures in psychiatry and psychology and continues to do remarkable work even at the age of 100. Can you tell us about the work he is engaged in these days? What do you see as his most important legacy?

: My father still works with his research team, formerly at the University of Pennsylvania and now at Beck Institute, on the development and dissemination of CT-R. He has developed several new theoretical models that underlie the treatment and apply broadly to various diagnoses. While I do think CT-R will be a key piece of his legacy, we should not forget that before him, there really was not a concept of evidence-based psychotherapy. It is because of his work that we now know talking therapies can be effective, and in some cases, even more effective than medication.

: What do you think the future of psychotherapy is? What would you like it to be?

: A number of years ago, a colleague asked my dad whether he expected cognitive therapy to eventually dominate the field of psychotherapy. He responded, “I hope good therapy eventually dominates the field of psychotherapy. Just good therapy.” My father has always said, and I agree, that if significant research demonstrates greater support for the theoretical framework and treatment of a different psychotherapy, then that psychotherapy should supplant CBT. So far that has not happened. To the contrary, as the years have gone by, there is more and more support for CBT conceptually and in treatment efficacy.

In terms of the future of CBT, I think we will continue to use research from other fields (such as neurobiology, evolutionary biology, and cognitive science) to refine theory and guide therapy. We will continue to seek out what treatments work best for whom under what conditions. We will have a stronger emphasis on identifying key processes to target core mediators and moderators based on testable theories.

I think CBT will continue to be adapted for more problems, diagnoses, and conditions. We will train many kinds of caregivers, teachers, front-line workers, police, and even politicians. More and more health care providers, such as occupational therapists, physical therapists, primary and specialty care providers will use CBT. Eventually, if the US adopts a single-payer medical system, I think we will see a triage system like the Improving Access to Psychological Therapies program in the UK and other countries. We will see innovative ways to deliver treatment, such as by grandmothers sitting on friendship benches in Zimbabwe or lay counselors in primary care in India. We will see a greater use of technology for self-administered and computer-assisted therapy by way of apps and computer programs and a greater use of texting and telehealth services. We will also see applications of technology to better deliver training and supervision of trainees and for monitoring and evaluating therapists.

And if research continues to confirm the efficacy of CT-R, I predict that we will see principles of CT-R incorporated into the treatment of all individuals, regardless of diagnosis, severity of condition, setting, care provider, or delivery method.

The opinions expressed in the interviews are those of the participants and do not necessarily reflect the opinions of 

is a psychiatrist in Cleveland, Ohio, and clinical assistant professor of psychiatry at Case Western Reserve University. He can be reached at 

Dr Aftab and Dr Beck have no relevant financial disclosures or conflicts of interest.

1. Hofmann SG, Asnaani A, Vonk IJ, et al. The efficacy of cognitive behavioral therapy: a review of meta-analyses. 

How can cognitive behavioral therapy be adapted to different cultures and address larger social issues?

The Past, Present, and Future of Cognitive Behavioral Therapy: Q&A with Judith S. Beck, PhD

Around the world, 5 billion individuals have mobile devices, half of which are 

 It is therefore unsurprising that mobile technology has become a core component of digital therapeutics (DTx). Today’s mobile technology allows mental health DTx to be more than simple remote assessment tools that report patient outcomes like those of the Patient Health Questionnaire-9. Rather, the latest DTx aim to deliver medical interventions directly to patients, using software intended to treat, manage, and potentially prevent disease.

Although care access is a key issue that digital solutions can improve, DTx also create an opportunity for genuine innovation. In fact, DTx are not necessarily diluted versions of in-person psychotherapy. Rather, in some cases they give rise to a mechanism of action enabled by the digital medium itself. For example, Akili’s EndeavorRx uses video game dynamics to train attentional processes in an intervention for children with attention-deficit/hyperactivity disorder. Omada Health delivers a digital version of the evidence-based Diabetes Prevention Program because it is a lifestyle intervention, including a support component enabled by technology and weight monitoring through connected devices. Pear Therapeutics’ reSET and reSET-O are prescription DTx for substance use disorder and opioid use disorder, respectively, intended to provide cognitive behavioral therapy (CBT) as an adjunct to outpatient treatment.

Innovations, however, are not good simply because they exist. Clinicians will need to carefully and thoughtfully consider different DTx offerings, their claimed mechanisms of action, evidence for their efficacy and ease of use, and other relative strengths and weaknesses.

Why Are Mental Health DTx Primarily Based on CBT?

CBT lends itself to digitization because the way in which individuals interact with their devices—and the devices’ ubiquitous presence—matches, and even facilitates, the core principles of change that underpin the therapy. Hence, most DTx assert that they are based on CBT.

However, in order to claim theoretical foundations in CBT, an intervention must promote behavioral adaptation through 

: context engagement, attention change, and cognitive change.

 Context engagement helps promote adaptive associative learning beyond what is currently perceived by the person. Examples of context engagement strategies include behavioral activation and exposure therapies; in the latter case, virtual reality is being explored as a potential component of DTx for posttraumatic stress disorder.

 Attention change refers to a shift in attention to adaptive, relevant, nondistressing stimuli. This includes therapeutic processes such as attention training, acceptance or tolerance training, and mindfulness techniques. Cognitive change refers to a shift in one’s perspective on an event, which then affects the emotional significance and meaning of that event. This includes metacognitive awareness and cognitive distancing, which are promoted through therapeutic processes such as cognitive reframing or reappraisal.

These 3 principles all have in common the need to draw awareness to, record, and evaluate how the patient experiences and interacts with the world. In this model, anything that facilitates these practices in an ecologically valid way may amplify their therapeutic effect. The therapeutic relationship in CBT is characterized by collaborative empiricism, wherein the therapist encourages symptom self-monitoring with a view to constructing experiments and opportunities to challenge one’s world view. In traditional therapist-delivered CBT, data have shown that the more a patient adheres to these tasks between sessions, the better their 

 Well-designed DTx have the potential to make those homework tasks easy. Beyond being a simple matter of convenience, making homework easy may have particular potency in some diagnoses, like major depressive disorder, in which lack of motivation (anhedonia) and a sense of disconnection are pervasive. Setting up the patient for success with tasks that facilitate therapeutic processes, especially in a way that is achievable and minimizes cognitive burden, can build self-efficacy and could accelerate time to recovery. While many such DTx are still in development, some have demonstrated potential to meaningfully reduce symptoms in just 2 weeks of use compared with a psychoeducation control group.

The overall contribution of these 3 foundational CBT principles to the treatment of an individual will depend on that individual and the issues with which they present. Some patients will have more insight or self-awareness of their emotional state or of their negative automatic thoughts and, therefore, may need to work less on attention change. Similarly, a patient with a specific phobia may need to work more on context engagement, using exposure techniques to relearn and diffuse previously learned negative associations. An experienced CBT therapist will make these modifications instinctively. Although the earlier waves of digital CBT were mostly one-size-fits-all applications, more recent digital solutions can include an innumerable number of skills and techniques from several therapeutic approaches (ie, CBT, interpersonal therapy, and dialectical behavior therapy) and adaptively meet patients where they are clinically.

As artificial intelligence (AI) and machine learning (ML) technology advances, DTx have an opportunity to grow beyond limited and inflexible content streams and become responsive to the patient’s present emotional state and circumstances (

). This is especially important, because maintaining user engagement over time proves challenging for many DTx. One approach is to use a relational agent, which is a specialized type of chatbot purpose-built to replicate some of the unique traits and dynamics of human interpersonal relationships. One such chatbot—Woebot—demonstrated Working Alliance Inventory – Short Revised scores comparable with those reported in the literature for traditional outpatient individual and group CBT. These results demonstrate that DTx can establish a 

Additionally, research has shown that individuals are more willing to disclose personal information to a virtual human, as doing so lowers fear of self-disclosure and impression management.

 This may be particularly important in adolescents, who prefer online or mobile tools over face-to-face interactions and tend to fear the stigma associated with seeking traditional mental health services.

 DTx have even been successfully deployed as an adjunctive treatment in challenging populations such as patients with early psychosis.

Perhaps unsurprisingly, the world is inundated by an ever-growing number of DTx—mostly in the form of mental health apps—that make broadly similar claims. However, few of these have chosen the path of clinical validation and regulatory approval. Many have no intention to pursue a regulated pathway given the time and cost involved. Just because a DTx app is available on Google Play and the App Store does not mean that any of its claims are valid. More importantly, a poorly designed app could be unhelpful, or even harmful.

Regulation of DTx brings rigor in terms of clinical efficacy, risk, and safety, as well as to the DTx development process. This is critical as many DTx rely on AI and ML algorithms that must be rigorously, accurately, and fairly trained and tested on clinically validated datasets. Results of such analyses must also be clearly and transparently reported.

 The US Food and Drug Administration has recently proposed a regulatory action plan that would encompass the entire life cycle of software as a medical device, an acknowledgment that AI and ML models often need regular updating, retraining, and retesting to ensure 

Every new treatment modality carries unique difficulties. For example, identification of safety events (ie, suicidal or homicidal ideation, intent, or plan) is a particular challenge for DTx utilizing relational agents where there is no human continuously monitoring interactions. Since DTx allow for 24/7 access and virtual support, they will need to detect crises accurately and provide appropriate assistance. As such, mental health DTx can be seen as a way of augmenting and enhancing rather than replacing human-to-human care delivery.

Any new technology-based treatment should incorporate the needs of all stakeholders and consider the digital divide that could prevent access to those who may most benefit from DTx. Further, despite the fact that prescription-based DTx have been developed from psychological and behavioral sciences, clinical psychologists and their associated professions will not be in a position to prescribe them.

 These concerns are certainly not new to mental health care, but the incorporation of a new technological approach necessitates a nuanced evolution of how we think about and address them as a profession.

When faced with the prospect of recommending DTx to patients, clinicians may struggle to make sense of the seemingly unending parade of options, with widely varying degrees of quality and clinical validity. Several websites offer expert reviews of DTx apps, but these reviews do not always incorporate the essential voice of the patient (

Because many DTx solutions rely on CBT principles, a multidisciplinary approach can be useful. For instance, a psychiatrist considering a DTx app can seek input from clinical psychologist colleagues. Fundamentally, one must exercise common-sense clinical judgment when considering DTx. Are the claims made by the app feasible? Do you envision your patients being able to use and benefit from it? If possible, give the DTx app a test drive before recommending it.

DTx offer unique benefits for meeting patients where they are. However, they must be continually tested, validated, and tried in the real world if they are to become part of a comprehensive system of care that helps us improve mental health across the lifespan.

is a clinical research psychologist, an adjunct faculty member in the Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine, and the founder and president of 

is a practicing psychiatrist, an adjunct assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, and vice president and medical director of 

1. Silver L. Smartphone ownership is growing rapidly around the world, but not always equally. Pew Research Center. February 5, 2019. Accessed June 25, 2021. 

2. Mobile fact sheet. Pew Research Center. April 7, 2021. Accessed June 25, 2021. 

3. Mennin DS, Ellard KK, Fresco DM, Gross JJ. United we stand: emphasizing commonalities across cognitive-behavioral therapies. 

4. van’t Wout M, Spofford CM, Unger WS, et al. Skin conductance reactivity to standardized virtual reality combat scenes in veterans with PTSD. 

5. Callan JA, Kazantzis N, Park SY, et al. A propensity score analysis of homework adherence–outcome relations in cognitive behavioral therapy for depression. 

6. Lebeau RT, Davies CD, Culver NC, Craske MG. Homework compliance counts in cognitive-behavioral therapy. 

7. Riley BJ. The role of homework in exposure-based CBT outcome for problem gambling. 

8. Fitzpatrick KK, Darcy A, Vierhile M. Delivering cognitive behavior therapy to young adults with symptoms of depression and anxiety using a fully automated conversational agent (Woebot): a randomized controlled trial. 

9. Darcy A, Daniels J, Salinger D, et al. Evidence of human-level bonds established with a digital conversational agent: cross-sectional, retrospective observational study. 

10. Lucas GM, Gratch J, King A, Morency L-P. It’s only a computer: virtual humans increase willingness to disclose. 

11. Kretzschmar K, Tyroll H, Pavarini G, et al. Can your phone be your therapist? Young people’s ethical perspectives on the use of fully automated conversational agents (chatbots) in mental health support. 

12. D’Alfonso S, Santesteban-Echarri O, Rice S, et al. Artificial intelligence–assisted online social therapy for youth mental health. 

13. Stevens LM, Mortazavi BJ, Deo RC, et al. Recommendations for reporting machine learning analyses in clinical research. 

14. Artificial intelligence and machine learning in software as a medical device. US Food and Drug Administration. Updated January 12, 2021. Accessed June 25, 2021. 

15. Carl JR, Jones DJ, Lindhiem OJ, et al. Regulating digital therapeutics for mental health: opportunities, challenges, and the essential role of psychologists. 

Why are mental health digital therapeutics primarily based on CBT?

DTx and Cognitive Behavioral Therapy: Opportunities, Benefits, and Challenges of an Evolving Landscape

SPECIAL REPORT: SEXUAL AND GENDER MINORITIES PART 2

Sexual and gender minority (SGM) youth experience the same types of traumas as their non-SGM peers, including child maltreatment, domestic and community violence, accidents, traumatic death, and separation. SGM youth are also at elevated risk for stressors common among minorities. Furthermore, these youth experience distinct ongoing stress related to discriminatory societal, medical, educational, housing, employment and/or legal attitudes, norms and/or practices, among others. In addition, 

 are at increased risk for traumas that are specifically related to their sexual orientation, gender identity ,and/or expression. They may be bullied, sexually or physically assaulted, or rejected by their parents. Thus, these youth are at significantly greater risk for cumulative trauma exposure, and for developing the negative mental health and medical problems related to stigma, minority stress, and trauma.

Trauma-Focused Cognitive Behavioral Therapy

Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment for trauma-impacted youth, aged 3 to 17 years, and their nonoffending parents or primary caregivers.

 With 23 randomized controlled trials assessing efficacy, TF-CBT has the strongest evidence for improving youth posttraumatic stress disorder (PTSD) diagnosis or symptoms, as well as trauma-related depressive, anxiety, behavioral, or cognitive difficulties.

The TF-CBT model consists of 9 components summarized by the acronym PRACTICE; they compose 3 treatment phases (

). Typically, TF-CBT treatment includes 12 to 15 sessions, with each phase lasting 4 to 5 sessions. For youth who develop complex PTSD reactions to multiple or interpersonal traumas, the enhancing safety component is typically provided first, and the stabilization/safety phase may be longer relative to the other 2 phases, taking up to half of the treatment sessions. Parent participation is an important part of TF-CBT, with youth and parent(s) seen individually for half of each treatment session; several conjoint youth-parent sessions are also included. Abusive or rejecting parents have not usually been included in TF-CBT treatment. These sessions typically use gradual exposure, ie, increasingly calibrated direct discussion about the youth’s trauma reminders or personal trauma experiences and use of skills to cope with these. Evidence-based psychotherapies such as TF-CBT are the 

 with PTSD symptoms or other trauma-related difficulties.

During a year-long learning community sponsored by the National Child Traumatic Stress Network (NCTSN), TF-CBT was implemented with trauma-impacted 

 in order to modify the model for this population, collect data, and develop an implementation manual to describe these modifications. Family Acceptance Project (FAP) data so convincingly documented the impact of specific family rejecting and accepting behaviors on risk and well-being for SGM youth and provided an evidence-informed family intervention framework that TF-CBT developers made the decision to include rejecting parents of SGM youth in TF-CBT treatment. FAP developer, Caitlin Ryan, PhD, ACSW, helped incorporate core FAP principles and strategies into the modified TF-CBT SGM implementation manual.

 This manual describes an integrated TF-CBT-FAP framework for SGM youth recovery from trauma, and it is now available at no cost to clinicians.

For 1 year, -long program, 32 clinicians from 12 NCTSN sites used TF-CBT for trauma-impacted SGM youth in order to modify the model for this population, collect data, and develop an implementation manual to describe these modifications.

 The 24 youth—aged 8 to 12 years, with diverse gender identities and sexual orientations—experienced significant improvement on the University of California, Los Angeles PTSD Reaction Index for DSM-5 from pre- to post-treatment (mean scores of 44.0 [severe] to 17.89 [normal]; t = 5.59; P < .0001). In a subsequent 

, 19 youth aged 10 to17 years who self-identified as SGM and received TF-CBT with these modifications experienced improvement in the Child PTSD Symptom Scale for DSM-5 from pre-to post-treatment (mean scores of 50.05 [severe] to 26.21 [mild]; t = 7.65; P < .001).

The FAP is a research, education, intervention, and policy initiative that was developed in 2002 by Ryan and colleague Rafael Diaz, PhD. The goal was to help families support their SGM children to reduce health risks and promote well-being in the context of their families, cultures, and faith communities. FAP conducted the first comprehensive research on SGM youth and families and developed the first evidence-informed family support model for use in family guidance and treatment approaches for prevention, wellness, and care for SGM children and adolescents.

FAP’s family support model is grounded in participatory mixed methods research with diverse SGM youth and families. FAP’s research identified more than 100 specific behaviors that parents and caregivers use to express rejection and acceptance of their SGM children and measured these behaviors to show how they contribute to health risks and decreased well-being. FAP worked with racially, religiously, and linguistically diverse families and SGM youth to develop intervention strategies and multilingual research-based resources that can help families decrease rejection and increase support and acceptance for their SGM children.

FAP’s family support model can be implemented to reduce risk for suicidality, depression, illegal drug use, ejection and removal from the home; to decrease family rejection; and to promote well-being. FAP strategies and resources can be used in any setting and by families. Moreover, core FAP intervention components can be integrated into other models of treatment, prevention, and care—as was done to integrate FAP and TF-CBT to support recovery and promote well-being for SGM children and youth, whether or not 

 is related to the child or youth’s SGM identity.

FAP’s family support model uses a strengths-based and harm reduction framework to help parents, families, and caregivers understand sexual orientation and gender identity as components of child development. It teaches them how specific reactions to their SGM child affects the child’s well-being and impacts their child’s risk for suicide, depression, illegal drug use, and HIV (

FAP has developed a series of research-based education materials to help parents understand the importance of family support, to guide behavioral change, and to educate extended family members as well as cultural and religious leaders. These resources include: family intervention videos that portray how diverse families move from struggle to support of their SGM children; family education booklets that are best practice resources for 

; assessment scales to measure growth and change; and a multilingual 

 series that tells the story of family acceptance and rejection, suitable for use in homes, congregations, and any other public, institutional and clinical settings (

Family Rejecting Behaviors That Are Traumatic

A critical element of FAP’s approach is helping parents and clinicians understand that family behaviors that reject a child’s core identity are traumatic and, combined with other trauma experiences, can contribute to complex mental health issues. Like Adverse Childhood Experiences (ACEs), the family rejecting (and accepting behaviors) identified and measured in FAP’s research are predictive of risk for suicidal behavior, depression, illegal drug use, risky sexual behavior and decreased well-being in adulthood. But unlike ACEs, these specific family rejecting behaviors are screened by few practitioners in 

 for these specific family rejecting behaviors. FAP’s family support model aligns these research findings with the parent’s underlying cultural and religious values to support positive behavioral change.

Parents are typically surprised to learn that these “well-meaning” behaviors to help their child fit in, have a good life, and be accepted by others are actually contributing to high levels of depression, suicidality, substance use, and other adverse outcomes. Yet, all of the specific family rejecting behaviors studied by FAP focus on trying to change, prevent, deny, and minimize a child’s SGM identity. Caregivers who believe that being gay or 

 is wrong routinely engage in rejecting behavior at early ages that undermine their child’s self-worth, increase isolation and hopelessness, erode the parent-child bond, and significantly increase the likelihood of suicidal and self-harming behaviors.

In aligning the FAP and TF-CBT models, the significant benefits of integrating them became obvious. Applying core FAP strategies and resources in TF-CBT enables clinicians to help parents understand the 

harmful impact of specific rejecting behaviors

, such as preventing the youth from having an SGM friend or making them pray or attend religious services to try to change their SGM identity (

). FAP’s behavioral approach motivates parents to change harmful rejecting behaviors and to engage in affirming behaviors that increase connectedness and reduce risk—even when they continue to believe that being gay or transgender is wrong.

While the focus of treatment in TF-CBT remains on the child or youth, FAP is expanding the focus on the critical role of family support. Efforts to change a child’s sexual orientation and gender identity expression are reinforced by social, cultural, and religious norms and are transmitted intergenerationally as a cultural default position. Helping the parent understand, take responsibility for, and ask the child’s forgiveness for behaviors that have denigrated the child’s SGM identity becomes part of the transformative narrative of TF-CBT for both the child and the parent.

TF-CBT and FAP’s integrated framework provides a pathway to healing and recovery that strengthens families and engages parents and caregivers as allies, not adversaries, for their SGM children.

TF-CBT and FAP help the parent and child to create meaning out of traumatic and harmful experiences and empower parents to nurture their SGM child. The COVID-19 pandemic has heightened vulnerability for SGM children and youth in numerous ways by confining them with rejecting and abusive family members, separating them from supportive peers and adults outside the home, and resulting in the sudden death of family members and cultural leaders. This combined treatment approach can play a crucial part of our national recovery.

is the medical director of the Center for Traumatic Stress in Children & Adolescents at Allegheny General Hospital in Pittsburgh, and professor of Psychiatry at Drexel University College of Medicine in Philadelphia.

 is the director of the Family Acceptance Project at San Francisco State University. A clinician and researcher with more than 40 years of experience working on LGBTQ health issues, she and her colleagues conducted the first research on LGBTQ youth and families and developed the first evidence-informed family support model to help diverse families to support their LGBTQ children. Dr Cohen receives grant funding from the Substance Abuse and Mental Health Services Administration and the National Institute of Mental Health, and royalties from Guilford Press, Up To Date, and the Medical University of South Carolina.

Treating Trauma and Traumatic Grief in Children and Adolescents, 2nd ed

2. Cohen JA, Mannarino AP, Deblinger E, eds. 

Trauma-Focused CBT for Children and Adolescents: Treatment Applications

3. Cohen JA, Bukstein O, Walter H, et al; AACAP Work Group on Quality Issues. 

Practice parameter for the assessment and treatment of children and adolescents with posttraumatic stress disorder.

4. Cohen JA, Mannarino AP, Wilson K, Zinny A. 

Trauma‐Focused Cognitive Behavioral Therapy LGBTQ Implementation Manual

5. Cohen JA. Trauma-focused cognitive behavioral therapy (TF-CBT) for LGBTQ youth. 

6. Cohen JA. Trauma-Focused-CBT for LGBTQ youth across systems of care. Paper presented at: American Academy of Child and Adolescent Psychiatry; October 19-24, 2020; virtual meeting. Accessed April 12, 2021. 

https://aacap.confex.com/aacap/2020/meetingapp.cgi/Paper/35840

7. Ryan C. Generating a revolution in prevention, wellness, and care for LGBT children and youth. 

Temple Political & Civil Rights Law Review

 Implementing the Family Acceptance Project’s family support model: practice guidance

. San Francisco; Family Acceptance Project, Marian Wright Edelman Institute, San Francisco State University.

9. Ryan C. Supportive Families, Healthy Children: Helping Families With Lesbian, Gay, Bisexual, and Transgender ChildrenFamily Acceptance Project at San Francisco State University; 2009. Accessed April 12, 2021. 

https://familyproject.sfsu.edu/sites/default/files/FAP_English%20Booklet_pst.pdf

10. Ryan C. Poster guidance and Healthy Futures poster series. Marian Wright Edelman Institute. 2019. Accessed April 12, 2021. 

11. Ryan C. The family acceptance project’s model for LGBTQ youth. 

12. Glassgold J, Ryan C. The role of families in efforts to change, support, and affirm sexual orientation, gender identity and expression in children and youth. In: Haldeman DC, ed. 

Change Efforts in Sexual Orientation and Gender Identity: From Clinical Implications to Contemporary Public Policy

"Well-meaning" behavior by parents or guardians could be contributing to high levels of depression, suicidality, substance use, and other adverse outcomes in their child.

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New research highlights the potential benefits and detriments of treatment strategies for ADHD, which include both pharmacological and nonpharmacological options (

Stimulants are the first line of treatment for ADHD and are typically well tolerated. Although there are potential adverse effects associated with stimulant administration, the most common are usually transient or dose related. One of the more serious effects is stimulant-induced psychosis.

To explore this risk, Moran and colleagues

 examined the records of 337,919 young persons aged 13 to 25 who had an ADHD diagnosis and were newly prescribed a stimulant medication. The researchers found 343 episodes of new-onset psychosis among the 221,846 study-matched population over an 11-year period. The median time from which the first stimulant was dispensed to the psychotic episode was 128 days.

The researchers concluded that the risk of new-onset psychosis was approximately doubled for individuals who received amphetamine compared with those who received methylphenidate. This supported their hypothesis, which was based on the similarities between idiopathic psychosis and the biologic effects of amphetamine. Individuals with primary psychosis have higher presynaptic dopaminergic capacity, which is an index of dopamine release.

Limitations of the study included: unmeasured confounding factors (ie, underreporting of substance use disorder), not knowing if the patients actually took the stimulant medication (there is a high rate of diversion, which is greater for amphetamine than methylphenidate), and the study findings, are not generalizable as the data were only from commercial insurance claims and did not take into account patients with no insurance or public insurance.

While the exact therapeutic mechanism of action of stimulants is unknown, they are thought to increase the availability of dopamine in the postsynaptic cleft by blocking the reuptake of dopamine. Amphetamine blocks the ability of the dopamine transporter to remove dopamine from the synapse, facilitates the reuptake of dopamine across the cell membrane, increases the release of vesicular dopamine (accumulates in the cytoplasm), and inhibits the degradative enzymes monoamine oxidase A and B. Methylphenidate binds to the dopamine transporter in the presynaptic cell membrane, blocking the reuptake of dopamine and, therefore, causing an increase in extracellular dopamine. The difference is that methylphenidate does not promote dopamine release from synaptic vesicles. Moreover, amphetamine induces the release of four times as much dopamine as methylphenidate.

 This increase of dopamine may contribute to adverse effects such as stimulant-induced psychosis.

Cases of stimulant-induced psychosis have been reported as early as 1938.

 However, the first case of a child who experienced auditory, tactile, visual hallucinations, and paranoia after treatment with a therapeutic dose of D-amphetamine for hyperactivity was not published until 1967.

 The 8-year-old child’s symptoms of psychosis resolved after the medication was discontinued. A few years later, similar cases were reported by Lucas and Weiss

 after they observed “psychotic reactions” in two children following a short-term therapeutic dose and in an adolescent after ingestion of excess medication after long-term use of a therapeutic dose of methylphenidate, which had been prescribed for hyperactivity.

It was not until 2007 that the FDA mandated a drug label warning that stimulants may cause psychosis in patients with no prior history. There remains limited data on whether the risk of psychosis differs among the two classes of stimulants.

While the incidence of new-onset psychosis with stimulant treatment for ADHD is small, this can be a frightening experience for the child as well as his or her parent and may negatively impact a parent’s decision to pursue stimulant treatment options. Thus, nonstimulant and non-pharmacological treatment options are often requested. Indeed, many parents continue to search for 

, especially for children with a newly established diagnosis.

 Until recently, there have been no viable nonpharmacological alternatives.

Trigeminal nerve stimulation may offer a nonpharmacological option

With concerns over potential adverse effects of medications, other strategies have been explored for treating ADHD. Preliminary studies using trigeminal nerve stimulation (TNS) to treat ADHD symptoms have peaked interest as a potential alternative or adjunctive treatment to stimulant and non-stimulant medications. TNS is a non-invasive, home administered, well-tolerated approach that has 

 Researchers became interested in TNS for ADHD after observing improvements in concentration and attention on mood disorder rating scales.

The stimulation device is compact and worn on clothing during sleep. Thin wires from the stimulator are attached to adhesive electrode pads that are placed on the forehead bilaterally over the ophthalmic branch (V1) of the trigeminal nerve. A current is sent through the wires to activate the trigeminal nerve, which projects to the nucleus tractus solitarius activating the locus coeruleus and the reticular formation. These play a key component in cognitive functions, particularly in sustaining attention.

The recent double-blind sham control study by 

 looked at cortical activation mechanisms using a quantitative electroencephalogram. The researchers found increased spectral power in the right frontal and frontal midline bands with active TNS, hypothesizing that activation of the frontobasal ganglia network targets hyperactivity and impulsivity. This mechanism of action helps to support the overall findings for improvement in both the inattention and hyperactivity components of ADHD.

During trials, the pattern of improvement on ADHD Rating Scale-IV (ADHD-RS) as well as on the Connor’s rating scale was comparable to that seen with non-stimulant medication.

 In this double-blind sham-controlled study by McGough and colleagues, symptomatic improvement was found to be highest after the first week of treatment; scores continued to improve over the next 3 weeks. While the sham group showed improvement over the first week, it was followed by a flattening response. One week after treatment discontinuation, rating scales were again administered in both the active and the sham groups. In both groups, scores from the ADHD-RS were found to decrease, indicating a recurrence of symptoms. This 4-week trial showed sustained improvement in both hyperactivity and inattention symptoms of ADHD with nightly active treatment.

Unfortunately, there are no long-term studies of mood or ADHD with TNS. Continued trials need to be undertaken to determine long-term outcomes as well as clear parameters for treatment.

The cost of the device used in the study, Monarch-TNS, is just over $1000; it is not currently covered by insurance. Other available TNS devices range between $250 and $450; their efficacy, however, is unknown. It is difficult to compare the cost of TNS versus stimulant and non-stimulant medications, since there is such a wide range in cost. The monthly cost ranges from approximately $8 for a generic stimulant and may exceed $288 for a branded product. Most insurance companies will cover at least some medication costs.

TNS has been well tolerated with high safety and compliance rates. A long-term follow-up study for TNS use in epilepsy demonstrated skin irritation as the main adverse effect from treatment.

 of short-term TNS include headache and eye twitches.

 Based on the 4-week double-blind sham study, the manufacturer of the Monarch-TNS treatment device also noted drowsiness, increased appetite, trouble sleeping, and fatigue as possible side effects. No withdrawal effects have been observed.

 suggest that TNS may be effective for ADHD as an alternative treatment to stimulant and non-stimulant medications given symptomatic improvement in both inattention and hyperactivity symptoms of ADHD. Although direct comparison of TNS to pharmacological treatment has not been undertaken, treatment may be considered in children with parental preference against pharmacological treatment after providing psychoeducation or in children who cannot tolerate psychotropic medications. TNS as an adjunctive therapy may also be considered; however, adjunctive use has not been studied.

Currently, several limitations remain a concern. First, clear parameters (eg, duration of treatment, number of treatments, the need for booster sessions) have not yet been identified. Second, there are no long-term studies for mood symptoms or ADHD, which limits the available data on long-term efficacy for TNS as a treatment. Third, the device itself is available but will come at a high out-of-pocket cost, thereby restricting treatment access.

Based on these limited data, TNS appears to be an effective, safe, well-tolerated option with high compliance rates. Although more studies are needed, this treatment has high potential for use in managing the symptoms associated with ADHD.

Dr Griffin is Assistant Professor of Psychiatry, the Medical Director of Outpatient Child and Adolescent Psychiatry, and the Director of the Child and Adolescent ADHD Clinic at Rush University Medical Center, Chicago, IL. Dr Harari is a first-year Child and Adolescent Psychiatry Fellow at Rush University Medical Center. The authors report no conflicts of interest concerning the subject matter of this article.

 Moran LV, Ongur D, Hsu J, et al. Psychosis with methylphenidate or amphetamine in patients with ADHD. 

 Schiffer WK, Volkow ND, Fowler JS, et al. Therapeutic doses of amphetamine or methylphenidate differentially increase synaptic and extracellular dopamine. 

 Young D, Scoville WB. Paranoid psychosis in narcolepsy and the possible danger of Benzedrine. 

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 Lucas AR, Weiss M. Methylphenidate hallucinosis. JAMA. 1971;217:1079-1081.

 dosReis S, Park A, Ng X, et al. Caregiver treatment preferences for children with a new versus existing attention-deficit/hyperactivity. 

New research highlights the potential benefits and detriments of treatment strategies for ADHD, including both pharmacological and nonpharmacological options.

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