Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression

NCT ID: NCT01829100

Last Updated: 2017-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 895 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

Brief Summary

Psychological therapies for depression have demonstrated efficacy, but outcomes are still unsatisfactory, especially in cases with high comorbidity. Depression and anxiety co-occur in up to 69-75% of teens and intensify functional impairment and service use. This study will develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT) and conduct a pilot waitlist-controlled school-based study with 35 7th and 8th grade boys and girls with co-occurring depression and anxiety. Multi-reporter, multi-domain assessments will be conducted at initial screening, pre- and post-treatment, and 4-month follow-up. BA is a straightforward, but flexible and robust, therapy that has demonstrated strong results in adults. Current formulations of BA highlight the specific role of avoidance in depressotypic behavior. It presumes that anhedonia, isolation, and negative behaviors associated with depression function to avoid imminent distress even as it blocks access to otherwise available positive reinforcement. This study will therefore employ novel electronic diary technology to obtain Ecological Momentary Assessment and evaluate: (a) the function of avoidance in distinguishing youth with depression (n=35) from a non-clinical comparison group (n=18), and (b) the role of avoidance in mediating treatment gains in participants in the GBAT intervention.

Detailed Description

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.

Conditions

Depressive Disorder; Anxiety Disorders

Keywords

Adolescent; Transdiagnostic therapy; Behavioral activation; Exposure therapy; Depressive Disorder; Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Behavioral Activation Therapy

Group Behavioral Activation Therapy (GBAT)

Group Type: EXPERIMENTAL

Group Behavioral Activation Therapy (GBAT)

Intervention Type: BEHAVIORAL

GBAT consists of 15 weekly, hour-long sessions. The first five group sessions teach four core BA principles: (a) psychoeducation of anxiety and depression, (b) functional analysis and identifying the maintaining role of avoidance, (c) problem solving and approach-oriented decision-making, and (d) graded exposures and behavioral activation. The second five group sessions consist of graded exposures or engagement exercises, where group members take turns practicing skills in role plays and in vivo exposures. Each youth receives two individual meetings (30-45 minutes) after the second and fourth group sessions. The first individual meeting promotes engagement and motivation for the group; the second helps develop the youth's individual avoidance/challenge hierarchy.

waitlist

15-week waitlist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group Behavioral Activation Therapy (GBAT)

GBAT consists of 15 weekly, hour-long sessions. The first five group sessions teach four core BA principles: (a) psychoeducation of anxiety and depression, (b) functional analysis and identifying the maintaining role of avoidance, (c) problem solving and approach-oriented decision-making, and (d) graded exposures and behavioral activation. The second five group sessions consist of graded exposures or engagement exercises, where group members take turns practicing skills in role plays and in vivo exposures. Each youth receives two individual meetings (30-45 minutes) after the second and fourth group sessions. The first individual meeting promotes engagement and motivation for the group; the second helps develop the youth's individual avoidance/challenge hierarchy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• an anxiety disorder (Generalized Anxiety Disorder [GAD], Social Phobia [SOP], Separation Anxiety [SAD]).

Exclusion Criteria

• any principal diagnosis other than anxiety or depression or parent report of mental retardation,
• pervasive developmental disorder,
• schizophrenia, or
• bipolar disorder, or
• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Klingenstein Third Generation Foundation

OTHER

Sponsor Role: collaborator

Rutgers University

OTHER

Sponsor Role: lead

Responsible Party

Brian Chu

Principal Investigator; Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian C Chu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Rutgers University

Piscataway, New Jersey, United States

Countries

United States

Other Identifiers

ChuDep2009

Identifier Type: -

Identifier Source: org_study_id