Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

April 25, 2012 updated by: Aude Henin, Massachusetts General Hospital

Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT
14-week individual cognitive-behavior therapy
Behavioral: cognitive-behavior therapy (CBT)
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.
No Intervention: Treatment As Usual
14-week waitlist control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Improvement Scale (CGI)-Improvement
Time Frame: week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-rated change in mood symptoms and overall functioning
week 5, week 10, week 14, 3 mo fu, 6 mo fu
feasibility and acceptability
Time Frame: post-treatment
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adapted Y-BOCS
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
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
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Social Adjustment Scale (SAS)
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses social, educational, occupational, and family functioning
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Timeline Follow-Back
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses alcohol and drug use over the past 30 days.
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
SCID depression and mania modules
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Medication history and adherence
Time Frame: baseline, post-treatment, 6 month follow-up
Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization
baseline, post-treatment, 6 month follow-up
Adult Suicidal Ideation Questionnaire (ASIQ)
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses severity of suicidal thoughts and behaviors
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
High-Risk Sexual Behaviors
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Beck Hopelessness Scale
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Barratt Impulsiveness Scale
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Self-Control Behavior Schedule
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Hamilton Depression Scale (HAM-D)
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-administered measure that assesses severity of depressive symptoms over the past week
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Young Mania Rating Scale
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-administered measure that assesses severity of manic symptoms over the past week.
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Treatment Satisfaction Questionnaire
Time Frame: post-treatment
Assesses participants' satisfaction with the treatment received
post-treatment
Urine Toxicology Screen
Time Frame: baseline, post-treatment, 6 mo follow-up
baseline, post-treatment, 6 mo follow-up
Risky Driving Inventory
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
South Oaks Gambling Screen
Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Aude Henin, Ph.D., Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH081335 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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