Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: cognitive-behavior therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>14-week individual cognitive-behavior therapy | Behavioral: cognitive-behavior therapy (CBT)<br>* 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.<br>|
| No Intervention: Treatment As Usual<br>14-week waitlist control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Improvement Scale (CGI)-Improvement | Clinician-rated change in mood symptoms and overall functioning | week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| feasibility and acceptability | We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures | post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adapted Y-BOCS | 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 | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| Social Adjustment Scale (SAS) | Assesses social, educational, occupational, and family functioning | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| Timeline Follow-Back | Assesses alcohol and drug use over the past 30 days. | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| SCID depression and mania modules | Clinician-administered measure that assesses the presence and severity of depression and mania over the past month. | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| Medication history and adherence | Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization | baseline, post-treatment, 6 month follow-up | 
| Adult Suicidal Ideation Questionnaire (ASIQ) | Assesses severity of suicidal thoughts and behaviors | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| 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 | 
| Self-Control Behavior Schedule | Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| Hamilton Depression Scale (HAM-D) | Clinician-administered measure that assesses severity of depressive symptoms over the past week | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| Young Mania Rating Scale | Clinician-administered measure that assesses severity of manic symptoms over the past week. | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| Treatment Satisfaction Questionnaire | Assesses participants' satisfaction with the treatment received | post-treatment | 
| Urine Toxicology Screen |  | baseline, post-treatment, 6 mo follow-up | 
| Risky Driving Inventory |  | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 
| South Oaks Gambling Screen |  | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorder, cognitive behavior therapy, alcohol abuse, drug abuse, high risk behaviors, medication adherence, psychosocial functioning