Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Aude Henin, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01176825
First received: August 5, 2010
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Behavioral: cognitive-behavior therapy (CBT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Clinical Global Improvement Scale (CGI)-Improvement [ Time Frame: week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
    Clinician-rated change in mood symptoms and overall functioning

  • feasibility and acceptability [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
    We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures


Secondary Outcome Measures:
  • Adapted Y-BOCS [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
    Assesses social, educational, occupational, and family functioning

  • Timeline Follow-Back [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
    Assesses alcohol and drug use over the past 30 days.

  • SCID depression and mania modules [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
    Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.

  • Medication history and adherence [ Time Frame: baseline, post-treatment, 6 month follow-up ] [ Designated as safety issue: No ]
    Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization

  • Adult Suicidal Ideation Questionnaire (ASIQ) [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: Yes ]
    Assesses severity of suicidal thoughts and behaviors

  • High-Risk Sexual Behaviors [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
  • Beck Hopelessness Scale [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
  • Barratt Impulsiveness Scale [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
  • Self-Control Behavior Schedule [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
    Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy

  • Hamilton Depression Scale (HAM-D) [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: Yes ]
    Clinician-administered measure that assesses severity of depressive symptoms over the past week

  • Young Mania Rating Scale [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: Yes ]
    Clinician-administered measure that assesses severity of manic symptoms over the past week.

  • Treatment Satisfaction Questionnaire [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
    Assesses participants' satisfaction with the treatment received

  • Urine Toxicology Screen [ Time Frame: baseline, post-treatment, 6 mo follow-up ] [ Designated as safety issue: No ]
  • Risky Driving Inventory [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]
  • South Oaks Gambling Screen [ Time Frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: September 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176825

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Aude Henin, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Aude Henin, Co-Director, Child CBT Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01176825     History of Changes
Other Study ID Numbers: R34MH081335, R34MH081335
Study First Received: August 5, 2010
Last Updated: April 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
bipolar disorder
cognitive behavior therapy
alcohol abuse
drug abuse
high risk behaviors
medication adherence
psychosocial functioning

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014