Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

NCT01176825 | Completed Phase 1 DMC

• 1 other identifier: R34MH081335
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; cognitive behavior therapy; alcohol abuse; drug abuse; high risk behaviors; medication adherence; psychosocial functioning

Outcome Measures

Primary Outcomes (2)

• Clinical Global Improvement Scale (CGI)-Improvement

  Clinician-rated change in mood symptoms and overall functioning

  week 5, week 10, week 14, 3 mo fu, 6 mo fu

• feasibility and acceptability

  We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures

  post-treatment

Secondary Outcomes (16)

• Adapted Y-BOCS

  baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

• Social Adjustment Scale (SAS)

  baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

• Timeline Follow-Back

  baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

• SCID depression and mania modules

  baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

• Medication history and adherence

  baseline, post-treatment, 6 month follow-up

Study Arms (2)

CBT

EXPERIMENTAL

14-week individual cognitive-behavior therapy

Behavioral: cognitive-behavior therapy (CBT)

Treatment As Usual

NO INTERVENTION

14-week waitlist control

Interventions

cognitive-behavior therapy (CBT) BEHAVIORAL

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.

CBT

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism; Substance-Related Disorders; Medication Adherence

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Chemically-Induced Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aude Henin, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Child CBT Program

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: September 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 26, 2012

Record last verified: 2012-04

Locations

US (1)