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Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cognitive-behavior therapy (CBT)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, cognitive behavior therapy, alcohol abuse, drug abuse, high risk behaviors, medication adherence, psychosocial functioning

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder)
  • ages 18-24 years
  • able to understand the nature of the study as well as potential risks and benefits
  • in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed.

Exclusion Criteria:

  • concurrent cognitive-behavioral psychotherapy
  • documented mental retardation
  • pervasive developmental disorder
  • current serious medical illness
  • inability to participate in the intervention because of acuity of symptoms
  • current drug or alcohol dependence (other than marijuana dependence)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT

Treatment As Usual

Arm Description

14-week individual cognitive-behavior therapy

14-week waitlist control

Outcomes

Primary Outcome Measures

Clinical Global Improvement Scale (CGI)-Improvement
Clinician-rated change in mood symptoms and overall functioning
feasibility and acceptability
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures

Secondary Outcome Measures

Adapted Y-BOCS
a version of the Yale-Brown Obsessive-Compulsive Scale that has been adapted to assess involvement in high-risk behaviors. This measure is individualized for each participant to assess their specific high-risk behavior that they would like to work on in treatment
Social Adjustment Scale (SAS)
Assesses social, educational, occupational, and family functioning
Timeline Follow-Back
Assesses alcohol and drug use over the past 30 days.
SCID depression and mania modules
Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.
Medication history and adherence
Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization
Adult Suicidal Ideation Questionnaire (ASIQ)
Assesses severity of suicidal thoughts and behaviors
High-Risk Sexual Behaviors
Beck Hopelessness Scale
Barratt Impulsiveness Scale
Self-Control Behavior Schedule
Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy
Hamilton Depression Scale (HAM-D)
Clinician-administered measure that assesses severity of depressive symptoms over the past week
Young Mania Rating Scale
Clinician-administered measure that assesses severity of manic symptoms over the past week.
Treatment Satisfaction Questionnaire
Assesses participants' satisfaction with the treatment received
Urine Toxicology Screen
Risky Driving Inventory
South Oaks Gambling Screen

Full Information

First Posted
August 5, 2010
Last Updated
April 25, 2012
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01176825
Brief Title
Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
Official Title
Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. The intervention also focuses on issues specific to transition-age youth. The study includes two phases: In phase 1, the intervention will be developed, refined, and openly piloted with several participants. In phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, cognitive behavior therapy, alcohol abuse, drug abuse, high risk behaviors, medication adherence, psychosocial functioning

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
14-week individual cognitive-behavior therapy
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
14-week waitlist control
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavior therapy (CBT)
Intervention Description
14 sessions of individual cognitive-behavior therapy. Sessions last 50-60 minutes and are held weekly. 2 optional monthly booster sessions may also be held after the end of treatment.
Primary Outcome Measure Information:
Title
Clinical Global Improvement Scale (CGI)-Improvement
Description
Clinician-rated change in mood symptoms and overall functioning
Time Frame
week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
feasibility and acceptability
Description
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
Time Frame
post-treatment
Secondary Outcome Measure Information:
Title
Adapted Y-BOCS
Description
a version of the Yale-Brown Obsessive-Compulsive Scale that has been adapted to assess involvement in high-risk behaviors. This measure is individualized for each participant to assess their specific high-risk behavior that they would like to work on in treatment
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Social Adjustment Scale (SAS)
Description
Assesses social, educational, occupational, and family functioning
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Timeline Follow-Back
Description
Assesses alcohol and drug use over the past 30 days.
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
SCID depression and mania modules
Description
Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Medication history and adherence
Description
Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization
Time Frame
baseline, post-treatment, 6 month follow-up
Title
Adult Suicidal Ideation Questionnaire (ASIQ)
Description
Assesses severity of suicidal thoughts and behaviors
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
High-Risk Sexual Behaviors
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Beck Hopelessness Scale
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Barratt Impulsiveness Scale
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Self-Control Behavior Schedule
Description
Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Hamilton Depression Scale (HAM-D)
Description
Clinician-administered measure that assesses severity of depressive symptoms over the past week
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Young Mania Rating Scale
Description
Clinician-administered measure that assesses severity of manic symptoms over the past week.
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
Treatment Satisfaction Questionnaire
Description
Assesses participants' satisfaction with the treatment received
Time Frame
post-treatment
Title
Urine Toxicology Screen
Time Frame
baseline, post-treatment, 6 mo follow-up
Title
Risky Driving Inventory
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Title
South Oaks Gambling Screen
Time Frame
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder) ages 18-24 years able to understand the nature of the study as well as potential risks and benefits in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed. Exclusion Criteria: concurrent cognitive-behavioral psychotherapy documented mental retardation pervasive developmental disorder current serious medical illness inability to participate in the intervention because of acuity of symptoms current drug or alcohol dependence (other than marijuana dependence)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aude Henin, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

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