Clinical trial NCT01829100: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorders
Keywords: Adolescent
Transdiagnostic therapy
Behavioral activation
Exposure therapy
Depressive Disorder
Anxiety Disorders
Lead sponsor: Rutgers University
Sponsor class: OTHER
Collaborators: name: The Klingenstein Third Generation Foundation
First posted: 2013-04-11
Enrollment: 895
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
timeFrame: Change from baseline (pretreatment) diagnosis at 15 weeks
Secondary outcomes:
measure: Change in Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Change from baseline (pretreatment) symptoms at 31 weeks
measure: Change in Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Change from baseline (pretreatment) symptoms at 15 weeks
measure: Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
timeFrame: Change from baseline (pretreatment) diagnosis at 31 weeks
Other outcomes:
measure: Change in Clinical Global Impression - Severity (CGI-S)
timeFrame: Change from baseline (pretreatment) impairment at 31 weeks
measure: Change in Screen for Child Anxiety Related Emotional Disorders (SCARED).
timeFrame: Change from baseline (pretreatment) symptoms at 31 weeks.
measure: Change in Center for Epidemiologic Studies-Depression Scale (CES-D).
timeFrame: Change from baseline (pretreatment) symptoms at 31 weeks
measure: Change in Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Change from baseline (pretreatment) impairment at 31 weeks.
measure: Change in Behavioral Activation of Depression Scale - Adolescent (BADS-A)
timeFrame: Change from baseline (pretreatment) activation at 31 weeks
measure: Change in Child Automatic Thoughts Scale (CATS)
timeFrame: Change from baseline (pretreatment) negative thinking at 31 weeks
measure: Change in Clinical Global Impression - Severity (CGI-S)
timeFrame: Change from baseline (pretreatment) impairment at 15 weeks
measure: Change in Screen for Child Anxiety Related Emotional Disorders (SCARED).
timeFrame: Change from baseline (pretreatment) symptoms at 15 weeks.
measure: Change in Center for Epidemiologic Studies-Depression Scale (CES-D).
timeFrame: Change from baseline (pretreatment) symptoms at 15 weeks
measure: Change in Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Change from baseline (pretreatment) impairment at 15 weeks.
measure: Change in Behavioral Activation of Depression Scale - Adolescent (BADS-A)
timeFrame: Change from baseline (pretreatment) activation at 15 weeks
measure: Change in Child Automatic Thoughts Scale (CATS)
timeFrame: Change from baseline (pretreatment) negative thinking at 15 weeks
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Brian C Chu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: