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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014