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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH081335 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT | Experimental | 14-week individual cognitive-behavior therapy |
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| Treatment As Usual | No Intervention | 14-week waitlist control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive-behavior therapy (CBT) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aude Henin, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| D064419 | Chemically-Induced Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |