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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Clinical Global Improvement Scale (CGI)-Improvement
Clinician-rated change in mood symptoms and overall functioning
Time frame: 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
Time frame: post-treatment
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
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Social Adjustment Scale (SAS)
Assesses social, educational, occupational, and family functioning
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline, post-treatment, 6 month follow-up
Adult Suicidal Ideation Questionnaire (ASIQ)
Assesses severity of suicidal thoughts and behaviors
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
High-Risk Sexual Behaviors
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Beck Hopelessness Scale
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Barratt Impulsiveness Scale
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Treatment Satisfaction Questionnaire
Assesses participants' satisfaction with the treatment received
Time frame: post-treatment
Urine Toxicology Screen
Time frame: baseline, post-treatment, 6 mo follow-up
Risky Driving Inventory
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
South Oaks Gambling Screen
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
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