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Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression

Primary Purpose

Depressive Disorder, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Behavioral Activation Therapy (GBAT)
Sponsored by
Rutgers University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Adolescent, Transdiagnostic therapy, Behavioral activation, Exposure therapy, Depressive Disorder, Anxiety Disorders

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Behavioral Activation Therapy

waitlist

Arm Description

Group Behavioral Activation Therapy (GBAT)

15-week waitlist

Outcomes

Primary Outcome Measures

Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
ADIS-IV-TR is a semi-structured interview that assesses presence and severity of DSM-IV-TR diagnoses, including parent, child, and consensus diagnosis. Impairment (Clinician's Severity Rating; CSR) is rated per disorder on a 0 (not at all) to 8 (debilitating) scale where 4 represents clinical threshold. The ADIS-IV-TR is administered at pretreatment, posttreatment, and 4-mo FU.

Secondary Outcome Measures

Change in Children's Depression Rating Scale-Revised (CDRS-R)
CDRS-R is a clinician-administered interview assessing depression severity over the past week, covering academic, social, health and cognitive functioning, and has been shown to be sensitive to treatment effects. The CDRS-R is administered at pretreatment, posttreatment, and 4-mo FU.
Change in Children's Depression Rating Scale-Revised (CDRS-R)
CDRS-R is a clinician-administered interview assessing depression severity over the past week, covering academic, social, health and cognitive functioning, and has been shown to be sensitive to treatment effects. The CDRS-R is administered at pretreatment, posttreatment, and 4-mo FU.
Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
ADIS-IV-TR is a semi-structured interview that assesses presence and severity of DSM-IV-TR diagnoses, including parent, child, and consensus diagnosis. Impairment (Clinician's Severity Rating; CSR) is rated per disorder on a 0 (not at all) to 8 (debilitating) scale where 4 represents clinical threshold. The ADIS-IV-TR is administered at pretreatment, posttreatment, and 4-mo FU.

Full Information

First Posted
April 4, 2013
Last Updated
October 15, 2017
Sponsor
Rutgers University
Collaborators
The Klingenstein Third Generation Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01829100
Brief Title
Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression
Official Title
The Function of Avoidance in Depressed Behavior and a Pilot of Transdiagnostic Behavioral Activation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
Collaborators
The Klingenstein Third Generation Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Anxiety Disorders
Keywords
Adolescent, Transdiagnostic therapy, Behavioral activation, Exposure therapy, Depressive Disorder, Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
895 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Behavioral Activation Therapy
Arm Type
Experimental
Arm Description
Group Behavioral Activation Therapy (GBAT)
Arm Title
waitlist
Arm Type
No Intervention
Arm Description
15-week waitlist
Intervention Type
Behavioral
Intervention Name(s)
Group Behavioral Activation Therapy (GBAT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
Description
ADIS-IV-TR is a semi-structured interview that assesses presence and severity of DSM-IV-TR diagnoses, including parent, child, and consensus diagnosis. Impairment (Clinician's Severity Rating; CSR) is rated per disorder on a 0 (not at all) to 8 (debilitating) scale where 4 represents clinical threshold. The ADIS-IV-TR is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) diagnosis at 15 weeks
Secondary Outcome Measure Information:
Title
Change in Children's Depression Rating Scale-Revised (CDRS-R)
Description
CDRS-R is a clinician-administered interview assessing depression severity over the past week, covering academic, social, health and cognitive functioning, and has been shown to be sensitive to treatment effects. The CDRS-R is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) symptoms at 31 weeks
Title
Change in Children's Depression Rating Scale-Revised (CDRS-R)
Description
CDRS-R is a clinician-administered interview assessing depression severity over the past week, covering academic, social, health and cognitive functioning, and has been shown to be sensitive to treatment effects. The CDRS-R is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) symptoms at 15 weeks
Title
Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
Description
ADIS-IV-TR is a semi-structured interview that assesses presence and severity of DSM-IV-TR diagnoses, including parent, child, and consensus diagnosis. Impairment (Clinician's Severity Rating; CSR) is rated per disorder on a 0 (not at all) to 8 (debilitating) scale where 4 represents clinical threshold. The ADIS-IV-TR is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) diagnosis at 31 weeks
Other Pre-specified Outcome Measures:
Title
Change in Clinical Global Impression - Severity (CGI-S)
Description
CGI-S is a widely-used clinician rating scale of symptom severity from 0 (no illness) to 6 (extremely severe) and is sensitive to treatment effects. The CGI-S is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) impairment at 31 weeks
Title
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED).
Description
SCARED is a 41-item self-report scale of anxiety symptoms experienced in the past three months. Total scores above 25 are indicative of an anxiety disorder. Previous research indicates strong discriminant and convergent validity. The SCARED is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) symptoms at 31 weeks.
Title
Change in Center for Epidemiologic Studies-Depression Scale (CES-D).
Description
CES-D is a 20 item self-report scale of depressive symptoms experienced over the past week. Total scores ≥ 21 predict significant presence of depression over the next year. Good psychometric data exist for use of the CES-D with adolescents. The CES-D is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) symptoms at 31 weeks
Title
Change in Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ is a 25-item behavioral screening questionnaire assessing five emotional and behavioral domains and has good psychometric properties (e.g., reliability and convergent validity). SDQ is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) impairment at 31 weeks.
Title
Change in Behavioral Activation of Depression Scale - Adolescent (BADS-A)
Description
BADS-A is a 26-item adaptation of the adult BADS and assesses behavioral activation and avoidance. BADS-A was adapted for the current study to reflect developmentally appropriate reading level and concepts. The BADS and BADS-A have strong psychometric properties including reliability and predictive validity. BADS-A is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) activation at 31 weeks
Title
Change in Child Automatic Thoughts Scale (CATS)
Description
CATS is a 40-item child-report measure designed to assess negative self-statements, and has demonstrated good reliability and discriminant validity. The CATS is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) negative thinking at 31 weeks
Title
Change in Clinical Global Impression - Severity (CGI-S)
Description
CGI-S is a widely-used clinician rating scale of symptom severity from 0 (no illness) to 6 (extremely severe) and is sensitive to treatment effects. The CGI-S is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) impairment at 15 weeks
Title
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED).
Description
SCARED is a 41-item self-report scale of anxiety symptoms experienced in the past three months. Total scores above 25 are indicative of an anxiety disorder. Previous research indicates strong discriminant and convergent validity. The SCARED is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) symptoms at 15 weeks.
Title
Change in Center for Epidemiologic Studies-Depression Scale (CES-D).
Description
CES-D is a 20 item self-report scale of depressive symptoms experienced over the past week. Total scores ≥ 21 predict significant presence of depression over the next year. Good psychometric data exist for use of the CES-D with adolescents. The CES-D is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) symptoms at 15 weeks
Title
Change in Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ is a 25-item behavioral screening questionnaire assessing five emotional and behavioral domains and has good psychometric properties (e.g., reliability and convergent validity). SDQ is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) impairment at 15 weeks.
Title
Change in Behavioral Activation of Depression Scale - Adolescent (BADS-A)
Description
BADS-A is a 26-item adaptation of the adult BADS and assesses behavioral activation and avoidance. BADS-A was adapted for the current study to reflect developmentally appropriate reading level and concepts. The BADS and BADS-A have strong psychometric properties including reliability and predictive validity. BADS-A is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) activation at 15 weeks
Title
Change in Child Automatic Thoughts Scale (CATS)
Description
CATS is a 40-item child-report measure designed to assess negative self-statements, and has demonstrated good reliability and discriminant validity. The CATS is administered at pretreatment, posttreatment, and 4-mo FU.
Time Frame
Change from baseline (pretreatment) negative thinking at 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian C Chu, Ph.D.
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

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Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression

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