Bipolar Disorder
Conditions
Keywords
bipolar disorder, cognitive behavior therapy, alcohol abuse, drug abuse, high risk behaviors, medication adherence, psychosocial functioning
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.
Interventions
BEHAVIORALcognitive-behavior therapy (CBT)
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.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Medication history and adherence | baseline, post-treatment, 6 month follow-up | Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization |
| 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 |
| 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 | — |
| 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 |
| 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 |
| 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. |
| Treatment Satisfaction Questionnaire | post-treatment | Assesses participants' satisfaction with the treatment received |
| 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 | — |
| 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 |
| Social Adjustment Scale (SAS) | baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu | Assesses social, educational, occupational, and family functioning |
Countries
United States
Outcome results
None listed