Clinical trial NCT01176825: Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
Official title: Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Disorder
Keywords: bipolar disorder
cognitive behavior therapy
alcohol abuse
drug abuse
high risk behaviors
medication adherence
psychosocial functioning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-08-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Clinical Global Improvement Scale (CGI)-Improvement
timeFrame: week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: feasibility and acceptability
timeFrame: post-treatment
Secondary outcomes:
measure: Adapted Y-BOCS
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Social Adjustment Scale (SAS)
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Timeline Follow-Back
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: SCID depression and mania modules
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Medication history and adherence
timeFrame: baseline, post-treatment, 6 month follow-up
measure: Adult Suicidal Ideation Questionnaire (ASIQ)
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: High-Risk Sexual Behaviors
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Beck Hopelessness Scale
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Barratt Impulsiveness Scale
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Self-Control Behavior Schedule
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Hamilton Depression Scale (HAM-D)
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Young Mania Rating Scale
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: Treatment Satisfaction Questionnaire
timeFrame: post-treatment
measure: Urine Toxicology Screen
timeFrame: baseline, post-treatment, 6 mo follow-up
measure: Risky Driving Inventory
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
measure: South Oaks Gambling Screen
timeFrame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aude Henin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: