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

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Overall Aim of the this project is to compare treatment outcomes and change in putative treatment mediators in Individual Behavioral Activation Therapy (IBAT) against two active psychological interventions (Coping Cat, PASCET) and a wait-list control. Participants will be 200 youth (ages 9-17) diagnosed with a principal anxiety or depression disorder and their caregivers.

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.

How is the treatment for anxiety and depression in youth using IBAT, Coping Cat, and PASCET unique?

This treatment is unique because it combines Behavioral Activation, which is promising for both anxiety and depression, with Cognitive Behavioral Therapy (CBT) programs like Coping Cat and PASCET, specifically designed for youth. It offers a comprehensive approach by addressing both anxiety and depression through evidence-based therapies tailored for children and adolescents. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Behavioral Activation and Exposure Therapy for Anxiety and Depression in Youth?

Research shows that Cognitive Behavioral Therapy (CBT), including the Coping Cat program, is effective for treating anxiety in children. Additionally, Behavioral Activation (BA) has shown promise in treating both anxiety and depression in young people, with studies indicating positive outcomes. ^{1 2 3 6 7}

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

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]

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]

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]

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 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]

Citations

1. England 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for child and adolescent anxiety disorders: an update on recent evidence. [2019]

3. England 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. [2021]

4. Canada 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. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Behavioral activation for children and adolescents: a systematic review of progress and promise. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Reduction in avoidance mediates effects of brief behavioral therapy for pediatric anxiety and depression. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adapting CBT for youth anxiety: Flexibility, within fidelity, in different settings. [2023]