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Behavioral Activation With Depressed Adolescents

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation Therapy
Treatment as Usual- Psychotherapy
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Adolescent Depression, Treatment of depression in adolescents, Behavioral activation treatment for depressed adolescents

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual- Psychotherapy

Behavioral Acitivation Therapy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Clinical Global Impressions Scale
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
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
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.

Full Information

First Posted
June 1, 2010
Last Updated
June 2, 2010
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01137149
Brief Title
Behavioral Activation With Depressed Adolescents
Official Title
Behavioral Activation Therapy With Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescent Depression, Treatment of depression in adolescents, Behavioral activation treatment for depressed adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual- Psychotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Behavioral Acitivation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy
Other Intervention Name(s)
Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual- Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale-Revised (CDRS-R)
Description
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.
Time Frame
Baseline assessment
Title
Children's Depression Rating Scale-Revised (CDRS-R)
Description
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.
Time Frame
End of Active Treatment (12 weeks)
Title
Children's Depression Rating Scale-Revised (CDRS-R)
Description
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.
Time Frame
At 9 months Follow-up Evaluaton
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Scale
Description
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.
Time Frame
Baseline (severity) assessment
Title
Clinical Global Impressions Scale
Description
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.
Time Frame
At the end of active treatment (12 weeks)
Title
Clinical Global Impressions Scale
Description
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.
Time Frame
At the 9 month follow-up evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth McCauley, PHD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Behavioral Activation With Depressed Adolescents

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