Behavioral Activation With Depressed Adolescents

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01137149
First received: June 1, 2010
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Depression
Behavioral: Behavioral Activation Therapy
Behavioral: Treatment as Usual- Psychotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation Therapy With Adolescents

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Baseline assessment ] [ Designated as safety issue: Yes ]
    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.

  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: End of Active Treatment (12 weeks) ] [ Designated as safety issue: Yes ]
    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.

  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: At 9 months Follow-up Evaluaton ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impressions Scale [ Time Frame: Baseline (severity) assessment ] [ Designated as safety issue: Yes ]
    The Clinical Global Impressions Scale will be utilized as an assessment of the severity of the adolescent's symptoms/level of symptom improvement as rated by the independent clinical evaluator. Scores range on a scale from 1-7, with lower scores denoting better outcome. The CGI measure has been widely utilized in a number of treatment outcome studies with adolescents to ascertain treatment response rate, with scores of 1 (very much improved) or 2 (much improved) indicating positive response to treatment.

  • Clinical Global Impressions Scale [ Time Frame: At the end of active treatment (12 weeks) ] [ Designated as safety issue: Yes ]
    The Clinical Global Impressions Scale will be utilized as an assessment of the severity of the adolescent's symptoms/level of symptom improvement as rated by the independent clinical evaluator. Scores range on a scale from 1-7, with lower scores denoting better outcome. The CGI measure has been widely utilized in a number of treatment outcome studies with adolescents to ascertain treatment response rate, with scores of 1 (very much improved) or 2 (much improved) indicating positive response to treatment.

  • Clinical Global Impressions Scale [ Time Frame: At the 9 month follow-up evaluation ] [ Designated as safety issue: Yes ]
    The Clinical Global Impressions Scale will be utilized as an assessment of the severity of the adolescent's symptoms/level of symptom improvement as rated by the independent clinical evaluator. Scores range on a scale from 1-7, with lower scores denoting better outcome. The CGI measure has been widely utilized in a number of treatment outcome studies with adolescents to ascertain treatment response rate, with scores of 1 (very much improved) or 2 (much improved) indicating positive response to treatment.


Enrollment: 60
Study Start Date: October 2006
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment as Usual- Psychotherapy
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
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.
Experimental: Behavioral Acitivation Therapy
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
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.
Other Name: Behavioral Therapy

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Adolescents will be excluded if they meet any of the following criteria:

  1. primary diagnosis other than a depressive disorder;
  2. presence of psychotic and/or manic symptoms;
  3. presence of chronic medical condition;
  4. presence of active substance abuse/dependence;
  5. presence of chronic self-mutilation or cutting (e.g., persistent, severe, and/or requiring medical treatment);
  6. presence acute or chronic suicidality (e.g., > 3 suicidal gestures in the past year),
  7. previous unfavorable response to an adequate regimen of either CBT or antidepressant treatment in the prior year, and/or (8)developmental delay.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137149

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Elizabeth McCauley, PHD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Elizabeth McCauley, PHD, Seattle Childrens' Hospital/University of Washington
ClinicalTrials.gov Identifier: NCT01137149     History of Changes
Other Study ID Numbers: BA Adolescent Study
Study First Received: June 1, 2010
Last Updated: June 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Adolescent Depression
Treatment of depression in adolescents
Behavioral activation treatment for depressed adolescents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014