Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression

NCT01829100 | Completed DMC

• 1 other identifier: ChuDep2009
• Study Type: interventional
• Target: 895
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Anxiety Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline (pretreatment) diagnosis at 15 weeks

Secondary Outcomes (3)

• Change in Children's Depression Rating Scale-Revised (CDRS-R)

  Change from baseline (pretreatment) symptoms at 31 weeks

• Change in Children's Depression Rating Scale-Revised (CDRS-R)

  Change from baseline (pretreatment) symptoms at 15 weeks

• Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)

  Change from baseline (pretreatment) diagnosis at 31 weeks

Other Outcomes (12)

• Change in Clinical Global Impression - Severity (CGI-S)

  Change from baseline (pretreatment) impairment at 31 weeks

• Change in Screen for Child Anxiety Related Emotional Disorders (SCARED).

  Change from baseline (pretreatment) symptoms at 31 weeks.

• Change in Center for Epidemiologic Studies-Depression Scale (CES-D).

  Change from baseline (pretreatment) symptoms at 31 weeks

Study Arms (2)

Group Behavioral Activation Therapy

EXPERIMENTAL

Group Behavioral Activation Therapy (GBAT)

Behavioral: Group Behavioral Activation Therapy (GBAT)

waitlist

NO INTERVENTION

15-week waitlist

Interventions

Group Behavioral Activation Therapy (GBAT) 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.

Group Behavioral Activation Therapy

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[SAD\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers University: lead
• The Klingenstein Third Generation Foundation: collaborator

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Brian C Chu, Ph.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Associate Professor

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 11, 2013
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

US (1)