Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Clinical Global Improvement Scale (CGI)-Improvement
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Aude Henin
Co-Director, Child CBT Program
Massachusetts General Hospital
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)
Outcomes
Primary Outcomes
Clinical Global Improvement Scale (CGI)-Improvement
Time Frame: week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-rated change in mood symptoms and overall functioning
feasibility and acceptability
Time Frame: post-treatment
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
Secondary Outcomes
- Self-Control Behavior Schedule(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Adapted Y-BOCS(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)
- Medication history and adherence(baseline, post-treatment, 6 month follow-up)
- High-Risk Sexual Behaviors(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Beck Hopelessness Scale(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)
- Barratt Impulsiveness Scale(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Young Mania Rating Scale(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)
- Adult Suicidal Ideation Questionnaire (ASIQ)(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Hamilton Depression Scale (HAM-D)(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Risky Driving Inventory(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Treatment Satisfaction Questionnaire(post-treatment)
- South Oaks Gambling Screen(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Urine Toxicology Screen(baseline, post-treatment, 6 mo follow-up)