Clinical trial NCT01137149: Behavioral Activation With Depressed Adolescents
Official title: Behavioral Activation Therapy With Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Depression
Keywords: Adolescent Depression
Treatment of depression in adolescents
Behavioral activation treatment for depressed adolescents
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Baseline assessment
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: End of Active Treatment (12 weeks)
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: At 9 months Follow-up Evaluaton
Secondary outcomes:
measure: Clinical Global Impressions Scale
timeFrame: Baseline (severity) assessment
measure: Clinical Global Impressions Scale
timeFrame: At the end of active treatment (12 weeks)
measure: Clinical Global Impressions Scale
timeFrame: At the 9 month follow-up evaluation
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Elizabeth McCauley, PHD
role: PRINCIPAL_INVESTIGATOR
References: