Completed

Transdiagnostic Group Behavioral Activation Therapy for Co-occurring Depression and Anxiety in Adolescents

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Study Aim

This study aims to treat co-occurring depression and anxiety in adolescents using Transdiagnostic Group Behavioral Activation Therapy, with the primary outcome being the change in diagnosis measured via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR).

What is being tested

Group Behavioral Activation Therapy (GBAT)

Behavioral
Who is being recruted

Mental Disorders+1

+ Mood Disorders

+ Anxiety Disorders

From 11 to 15 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2009
See protocol details

Summary

Principal SponsorRutgers University
Last updated: July 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2009

Actual date on which the first participant was enrolled.

Specific Aims and Hypotheses: This study will develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT). It will then conduct a double-gated screening of middle-school students (N=895) to identify youth with subclinical or clinical DSM-IV-TR anxiety or mood disorders. Eligible youth (N=35) will then participate in a randomized clinical trial of GBAT where 21 will be randomly assigned to GBAT and 14 to a 15-week waitlist period. This addresses critical needs to develop first-line early interventions that are evidence-based and can efficiently address commonly co-occurring problems in settings where treatment is needed most. Aim 1. To develop treatment materials and test GBAT's feasibility (e.g., recruitment and retention rates, therapist adherence) and acceptability to youth participants (client satisfaction, group cohesion, homework completion). Aim 2. To estimate initial efficacy of GBAT compared to a waitlist (WL) control in a randomized pilot study with 35 youth (21 assigned to two GBAT groups; 14 assigned to WL). It is hypothesized that GBAT will show greater pre- to post-treatment outcomes on primary (clinical diagnosis, symptom severity) and secondary measures (achievement of target goals, reduced avoidance, social and academic adjustment). Youth who receive GBAT will also show linear improvement on outcome measures from pretreatment through four-month follow-up. A second major goal of the project is to understand the functional role of avoidance in depression. Participating youth will carry Electronic Diaries (EDs; i.e., ipod touch) throughout the active treatment and follow-up phases and complete twice-daily reports of negative events, emotional and behavioral responses, and perceived function of one's responses. A non-clinical comparison group (n=18) will also carry EDs during a two-week period. Such Ecological Momentary Assessment (EMA) data has been used effectively with youth populations to determine the impact of positive and negative coping responses on depressive symptoms. Aim 3. The research suggests that depressed youth seek out depressogenic activities and respond less to positive events. Based on EMA data, the study hypothesizes that, compared to non-clinical comparisons: (a) depressed youth will identify more events as negative during the day, (b) depressed youth will respond with greater negativity than non-depressed youth, (c) the coping strategies used will be more avoidant or aimed at disengagement, and (d) the function of these strategies will be to minimize distress and conflict. Furthermore, youth who receive GBAT, compared to WL participants, will demonstrate increased ratio of engagement-based to avoidance-based coping strategies from pre- to post-treatment and 4-mo FU.

Principal SponsorRutgers University
Last updated: July 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

895 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 11 to 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersMood DisordersAnxiety DisordersDepressive Disorder

Criteria

2 inclusion criteria required to participate
an anxiety disorder (Generalized Anxiety Disorder [GAD], Social Phobia [SOP], Separation Anxiety [SAD])

clinical (ADIS CSR >= 4) or subclinical (ADIS CSR = 2-3) principal diagnosis of either a DSM-IV-TR unipolar depression disorder (Major Depressive Disorder ([MDD], Minor Depression [MinD], or Dysthymia [Dys]) or

5 exclusion criteria prevent from participating
any principal diagnosis other than anxiety or depression or parent report of mental retardation

bipolar disorder, or

pervasive developmental disorder

report of past-year hospitalization for a suicide attempt. Concurrent use of antidepressant or anxiolytic medications was permitted as long as dosage was stable for at least four weeks and the family intended to maintain the dose

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group Behavioral Activation Therapy (GBAT)

Group II

No Intervention
15-week waitlist

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Rutgers University

Piscataway, United StatesOpen Rutgers University in Google Maps
CompletedOne Study Center