Behavioral Activation With Depressed Adolescents

NCT01137149 | Unknown Phase 1 DMC

• 1 other identifier: BA Adolescent Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty percent of adolescents will have at least one episode of clinical depression by age 18, and 65% will experience transient or less severe depressive symptoms. Depression compromises the process of adolescent development by interfering with academic, occupational, and social functioning, and increasing risk for substance use and suicide. Although initial research provides some support for both pharmacological and psychosocial interventions, many depressed teens do not respond to these interventions, and others experience a relapse of symptoms within one year. Furthermore, concerns about antidepressant medications increasing suicide risk have raised additional caution about use of pharmacotherapy with adolescents. As such, the importance of developing innovative treatment options for depressed adolescents is critical. Cognitive Behavioral Therapy (CBT) has been demonstrated to be effective in the treatment of depressed adults, with more modest efficacy data when used with children and adolescents. Interestingly, recent data from the adult literature suggests the positive outcomes of CBT can be achieved and surpassed by interventions that are purely behavioral in nature. Behavioral interventions may be easier to implement with many adolescents and may provide a better developmental fit for depressed adolescents. The present project proposes to develop a manualized Behavioral Activation (BA) Therapy for depressed adolescents, test its adaptability, acceptability, and feasibility in an open clinical trial with 12 adolescents (aged 12-17), and following further treatment refinement, test its efficacy in a randomized controlled trial of 50 adolescents (aged 12-17), in which 25 will be randomized to BA Therapy and 25 will receive "Treatment as Usual (TAU)." In this randomized controlled trial, depressed adolescents will receive 12-weeks of BA Therapy or TAU. Psychiatric and psychosocial functioning will be assessed at the beginning, middle, and end of treatment. A naturalistic follow-up will be conducted 4 and 9 months post-treatment. Assuming that BA will outperform "usual" approaches to therapy with depressed youth, the data will provide the basis for the development of a larger randomized controlled trial comparing the efficacy of BA against other widely studied approaches to the treatment of depression in youth, namely pharmacotherapy in the form of Selective Serotonin Reuptake Inhibitors (SSRIs), and CBT.

Conditions

Depression

Keywords

Adolescent Depression; Treatment of depression in adolescents; Behavioral activation treatment for depressed adolescents

Outcome Measures

Primary Outcomes (3)

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

  The CDRS-R, an interview-based measure, will be administered by the blind independent evaluator with both the parent and adolescent. The CDRS-R has been found to be a sensitive and reliable severity measure of depression in children and adolescents. Ratings are made across 17 symptoms, including depressed feelings, sleep disturbance, and suicidal ideation, on a scale of 1 (no difficulties) to 7 (severe clinically significant difficulties). A raw score at or above 45 or a T-score at or above 65 is reported to be increasingly indicative of a likely depressive disorder.

  Baseline assessment

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

  The CDRS-R, an interview-based measure, will be administered by the blind independent evaluator with both the parent and adolescent. The CDRS-R has been found to be a sensitive and reliable severity measure of depression in children and adolescents. Ratings are made across 17 symptoms, including depressed feelings, sleep disturbance, and suicidal ideation, on a scale of 1 (no difficulties) to 7 (severe clinically significant difficulties). A raw score at or above 45 or a T-score at or above 65 is reported to be increasingly indicative of a likely depressive disorder.

  End of Active Treatment (12 weeks)

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

  The CDRS-R, an interview-based measure, will be administered by the blind independent evaluator with both the parent and adolescent. The CDRS-R has been found to be a sensitive and reliable severity measure of depression in children and adolescents. Ratings are made across 17 symptoms, including depressed feelings, sleep disturbance, and suicidal ideation, on a scale of 1 (no difficulties) to 7 (severe clinically significant difficulties). A raw score at or above 45 or a T-score at or above 65 is reported to be increasingly indicative of a likely depressive disorder.

  At 9 months Follow-up Evaluaton

Secondary Outcomes (3)

• Clinical Global Impressions Scale

  Baseline (severity) assessment

• Clinical Global Impressions Scale

  At the end of active treatment (12 weeks)

• Clinical Global Impressions Scale

  At the 9 month follow-up evaluation

Study Arms (2)

Treatment as Usual- Psychotherapy

ACTIVE COMPARATOR

The TAU condition will be implemented consistent with usual and customary clinical practices within the Child Psychiatry Clinic at Seattle Children's Hospital (SCH. Within the SCH system, TAU for a depressed adolescent will typically consist of an individual therapy approach with adjunct family sessions and pharmacotherapy as deemed necessary by the primary therapist. The therapeutic approach typically used is cognitive behavioral but is administered in an eclectic, non-manualized fashion. Therapists for the TAU arm of the study will be care providers currently working within the SCH system. For this phase of the study, we will draw on clinicians whose level of experience is comparable to that of the Behavioral Activation therapists.

Behavioral: Treatment as Usual- Psychotherapy

Behavioral Acitivation Therapy

EXPERIMENTAL

Behavioral activation is a 12 week psychotherapeutic intervention utilizing a semi-structured format. Initial sessions focus on specific areas (Assessment and orientation, Activation, Problem Solving, Goal Setting, Overcoming Barriers, Avoidance) interspersed as needed by sessions that focus on individual issues and applications. In these sessions the therapists maintains the session structure, but can use techniques presented in earlier sessions based on their functional analysis of the particular case. Parents participate in at least two of the ATA sessions but more active parental participation can be included as needed.

Behavioral: Behavioral Activation Therapy

Interventions

Behavioral Activation Therapy BEHAVIORAL

Behavioral activation is a 12 week psychotherapeutic intervention utilizing a semi-structured format. Initial sessions focus on specific areas (Assessment and orientation, Activation, Problem Solving, Goal Setting, Overcoming Barriers, Avoidance) interspersed as needed by sessions that focus on individual issues and applications. In these sessions the therapists maintains the session structure, but can use techniques presented in earlier sessions based on their functional analysis of the particular case. Parents participate in at least two of the ATA sessions but more active parental participation can be included as needed.

Also known as: Behavioral Therapy

Behavioral Acitivation Therapy

Treatment as Usual- Psychotherapy BEHAVIORAL

The TAU condition will be implemented consistent with usual and customary clinical practices within the Child Psychiatry Clinic at Seattle Children's Hospital (SCH. Within the SCH system, TAU for a depressed adolescent will typically consist of an individual therapy approach with adjunct family sessions and pharmacotherapy as deemed necessary by the primary therapist. The therapeutic approach typically used is cognitive behavioral but is administered in an eclectic, non-manualized fashion. Therapists for the TAU arm of the study will be care providers currently working within the SCH system. For this phase of the study, we will draw on clinicians whose level of experience is comparable to that of the Behavioral Activation therapists.

Treatment as Usual- Psychotherapy

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 11 and 18;
• one parent/legal guardian willing to participate in the study;
• primary diagnosis of a depressive disorder (Major Depressive Disorder, Dysthymia, Depression NOS);
• Short Mood and Feelings Questionnaire \>11;
• Children's Depression Rating Scale score \> 45;
• willingness to be randomized into either treatment group.

You may not qualify if:

• Adolescents will be excluded if they meet any of the following criteria:
• primary diagnosis other than a depressive disorder;
• presence of psychotic and/or manic symptoms;
• presence of chronic medical condition;
• presence of active substance abuse/dependence;
• presence of chronic self-mutilation or cutting (e.g., persistent, severe, and/or requiring medical treatment);
• presence acute or chronic suicidality (e.g., \> 3 suicidal gestures in the past year),
• previous unfavorable response to an adequate regimen of either CBT or antidepressant treatment in the prior year, and/or (8)developmental delay.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Behavior Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elizabeth McCauley, PHD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 4, 2010
• Study Start: October 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

US (1)