Behavioral Activation and Exposure Therapy for Anxiety and Depression in Youth

Overseen By Brian C Chu, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers University

Disqualifiers: Intellectual disability, Autism, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of different therapies for children and teens with anxiety or depression. It compares Individual Behavioral Activation Therapy (IBAT) with two other programs—The Coping Cat Program for Youth Anxiety Disorders and The PASCET Program for Youth Depressive Disorders—and a waitlist group to determine which best reduces anxiety and depression symptoms. Young people aged 9-17 diagnosed with conditions such as generalized anxiety or major depression, who can regularly attend therapy sessions, may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance mental health treatments for young people.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. However, you should work with your doctor to make sure your medication dosage and schedule are stable before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have used Individual Behavioral Activation Therapy (IBAT) to treat anxiety and depression in young people. Research shows it effectively lowers anxiety and depression scores, helping children feel better. Reports of serious side effects have been minimal, indicating it is well-tolerated.

A review of multiple studies on the Coping Cat program found it effectively reduces anxiety symptoms in children and adolescents, suggesting it is safe and effective for young people with anxiety.

The PASCET program helps children manage and reduce depression. Testing has shown it improves mood by teaching better coping skills. Studies report no major safety concerns, indicating it is a safe option for children dealing with depression.

Overall, these treatments show promise in helping young people with anxiety and depression without significant safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine behavioral activation and exposure therapy to tackle anxiety and depression in youth. Unlike traditional options like medication and cognitive-behavioral therapy, these approaches emphasize engaging in positive activities and facing fears in a structured way. The Coping Cat Program specifically helps kids manage anxiety by teaching them to recognize and confront anxious thoughts, while the PASCET Program focuses on building skills to combat depression through enjoyable, rewarding activities. Together, these methods aim to empower young people with practical tools to manage their mental health challenges effectively.

What evidence suggests that this trial's treatments could be effective for anxiety and depression in youth?

This trial will compare different treatments for anxiety and depression in youth. Research has shown that Individual Behavioral Activation Therapy (IBAT), one of the treatments in this trial, may help treat anxiety and depression in young people by encouraging participation in mood-boosting activities. The Coping Cat Program, another treatment option, has been tested in many trials and significantly reduces anxiety in children by teaching them ways to handle their fears. The PASCET Program, also part of this trial, has been studied for its ability to lessen depression in youth by improving their coping skills. Each of these treatments shows potential in addressing anxiety or depression, offering a structured way to help young people manage their conditions. ^{2 5 6 7 8}

Who Is on the Research Team?

Brian C Chu, Ph.D.

Principal Investigator

Rutgers University (Youth Anxiety and Depression Clinic)

Are You a Good Fit for This Trial?

This trial is for young people aged 9-17 with anxiety or depression disorders, including Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Specific Phobia, Panic Disorder, Agoraphobia, Major Depression Disorder and other depressive conditions.

Inclusion Criteria

I have been diagnosed with Major Depression Disorder.

I have been diagnosed with separation anxiety disorder.

I have been diagnosed with mild depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Individual Behavioral Activation Therapy (IBAT) or one of two active psychological interventions (Coping Cat, PASCET) for 14 weeks

14 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 14-week waitlist (WL) condition
• Individual Behavioral Activation Therapy (IBAT)
• The Coping Cat Program for Youth Anxiety Disorders
• The PASCET Program for Youth Depressive Disorders

Trial Overview The study compares Individual Behavioral Activation Therapy (IBAT) to two specific psychological programs (Coping Cat for anxiety and PASCET for depression), as well as a waitlist control group to see which is more effective in treating youth with these mental health issues.

How Is the Trial Designed?

Group I: Principal Depressive Disorder Experimental Treatment 3 Interventions

Youth with a principal unipolar depressive disorder

Group II: Principal Anxiety Disorder Experimental Treatment 3 Interventions

Youth with a principal anxiety disorder

Who Is Running the Clinical Trial?

Rutgers University

Lead Sponsor

Trials

127

Recruited

2,814,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) is an effective treatment for youth anxiety, but there is a significant gap in access to this therapy, highlighting the need for flexible delivery methods.

The paper reviews various adaptations of CBT for youth anxiety, including delivery in schools, community settings, telehealth, online programs, and by caregivers, providing strategies to maintain treatment effectiveness while increasing accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting CBT for youth anxiety: Flexibility, within fidelity, in different settings. Kendall, PC., Ney, JS., Maxwell, CA., et al.[2023]

A systematic review of 44 documents on 10 internet-based cognitive behavioral therapy (iCBT) programs for children and adolescents with anxiety identified key design features that enhance program use, including tailoring, personalization, and social support elements.

Programs that included adjunct support, such as face-to-face or online communication, showed higher engagement and completion rates, suggesting that combining multiple persuasive system design features can significantly improve the effectiveness of iCBT interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Delivery Features That May Improve the Use of Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Anxiety: A Realist Literature Synthesis With a Persuasive Systems Design Perspective. Radomski, AD., Wozney, L., McGrath, P., et al.[2020]

Behavioral activation (BA) shows promise as an effective treatment for anxiety and depression in children and adolescents, with 19 studies reviewed, including 4 randomized-controlled trials that reported positive outcomes.

While initial evidence supports the feasibility and acceptability of BA, the studies have small sample sizes and are primarily conducted in high-income settings, indicating a need for larger, culturally adapted trials in diverse environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for children and adolescents: a systematic review of progress and promise. Martin, F., Oliver, T.[2022]

Brief behavioral therapy (BBT) effectively reduces behavioral avoidance in youth aged 8-16, which is linked to improvements in anxiety and functioning, based on a study of 52 participants over 16 weeks.

Changes in youth-reported behavioral avoidance were found to mediate the treatment effects on anxiety, but not on depression, indicating that BBT specifically targets avoidance behaviors to alleviate anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in avoidance mediates effects of brief behavioral therapy for pediatric anxiety and depression. Baca, SA., Goger, P., Glaser, D., et al.[2023]

Cognitive behavior therapy (CBT) has shown both short and long-term efficacy for treating anxiety disorders in children and adolescents, but its effects are modest compared to active control conditions, and many youths do not achieve stable long-term remission.

There is a pressing need to develop cost-effective strategies to improve access to CBT and to identify predictors of treatment response, as a significant number of youths remain impaired even after therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for child and adolescent anxiety disorders: an update on recent evidence. Heiervang, ER., Villabø, MA., Wergeland, GJ.[2019]

A Randomized Controlled Trial (RCT) is being conducted with 130 Dutch primary school children aged 7 to 13 to evaluate the effectiveness of the 'Coping Cat' program, a cognitive behavioral therapy designed to reduce anxiety symptoms.

The study aims to identify mechanisms of effectiveness, such as active coping and positive cognitive restructuring, which could help in developing a scalable and cost-effective prevention program for childhood anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and underlying mechanisms of a group-based cognitive behavioural therapy-based indicative prevention program for children with elevated anxiety levels. van Starrenburg, ML., Kuijpers, RC., Hutschemaekers, GJ., et al.[2021]

Adolescents aged 12-19 found Brief Behavioural Activation (BA) helpful for self-discovery, gaining coping tools, and having supportive conversations with their therapist, highlighting its effectiveness in treating depression symptoms.

However, challenges such as the therapy's duration and difficulties in maintaining progress after treatment were noted as unhelpful aspects, suggesting areas for improvement in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

&#8201;"&#8230;&#8201;if I care about stuff, then other people care about me". Adolescents' experiences of helpful and unhelpful aspects of brief behavioural activation therapy for depression. Lewis-Smith, I., Pass, L., Jones, DJW., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618157/

Is behavioural activation an effective treatment for ... Individuals who received Self-Control Therapy demonstrated the highest reductions in anxiety at post-treatment. Several other anxiety measures ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6445819/

Behavioral activation for children and adolescents Behavioral activation (BA) effectively treats depression in adults, and shows promise in treating anxiety. Research into its application to children and ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/10503307.2023.2197630

Individual behavioral activation in the treatment of depression Although the quality of most of the trials was modest, this meta-analysis suggested that BA is an effective treatment for depression as well as other outcomes.

4. withpower.com withpower.com/trial/phase-depression-1-2018-8110a

Behavioral Activation and Exposure Therapy for Anxiety ... Additionally, Behavioral Activation (BA) has shown promise in treating both anxiety and depression in young people, with studies indicating positive outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000362

Behavioral activation to prevent depression in at-risk ... This study aimed to assess the feasibility, acceptability, and potential impact of a novel 5-week group Behavioral Activation (BA) prevention program for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03412227

Transdiagnostic Individual Behavioral Activation and ... IBAT is a manual-based, individual behavioral activation plus exposure therapy aimed at treating youth with anxiety, depression, and anger. The program consists ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10881118/

A randomized clinical trial of behavioral activation and ... Meta-analyses have demonstrated that EXP is highly effective for anxiety [6], [17]. For GAD in particular, EXP has been shown to effectively reduce behavioral ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2950004423000044

A randomized clinical trial of behavioral activation and ... Compared to EXP, BA yielded more rapid declines in anxiety and depression scores during therapy (d=0.75–0.77), as well as lower anxiety and depression scores (d ...