Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
- Conditions
- Bipolar Disorder
- Interventions
- Behavioral: cognitive-behavior therapy (CBT)
- Registration Number
- NCT01176825
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT cognitive-behavior therapy (CBT) 14-week individual cognitive-behavior therapy
- Primary Outcome Measures
Name Time Method Clinical Global Improvement Scale (CGI)-Improvement week 5, week 10, week 14, 3 mo fu, 6 mo fu Clinician-rated change in mood symptoms and overall functioning
feasibility and acceptability post-treatment We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
- Secondary Outcome Measures
Name Time Method Self-Control Behavior Schedule baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy
Adapted Y-BOCS baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu 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
Timeline Follow-Back baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu Assesses alcohol and drug use over the past 30 days.
Medication history and adherence baseline, post-treatment, 6 month follow-up Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization
Social Adjustment Scale (SAS) baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu Assesses social, educational, occupational, and family functioning
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 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 Clinician-administered measure that assesses severity of manic symptoms over the past week.
SCID depression and mania modules baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.
Hamilton Depression Scale (HAM-D) baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu Clinician-administered measure that assesses severity of depressive symptoms over the past week
Risky Driving Inventory 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 Assesses severity of suicidal thoughts and behaviors
Treatment Satisfaction Questionnaire post-treatment Assesses participants' satisfaction with the treatment received
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
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States