Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder - Full Text View

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:

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

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

National Institute of Mental Health (NIMH)

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 May 22, 2013