Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176825
• Other study ID #: R34MH081335
• Secondary ID: R34MH081335
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2010
• Last updated: April 25, 2012
• Start date: September 2007
• Est. completion date: November 2011

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 24 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• cognitive-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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	feasibility and acceptability	We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures	post-treatment	No
Secondary	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	No
Secondary	Social Adjustment Scale (SAS)	Assesses social, educational, occupational, and family functioning	baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu	No
Secondary	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	No
Secondary	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	No
Secondary	Medication history and adherence	Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization	baseline, post-treatment, 6 month follow-up	No
Secondary	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	Yes
Secondary	High-Risk Sexual Behaviors		baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu	No
Secondary	Beck Hopelessness Scale		baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu	No
Secondary	Barratt Impulsiveness Scale		baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Treatment Satisfaction Questionnaire	Assesses participants' satisfaction with the treatment received	post-treatment	No
Secondary	Urine Toxicology Screen		baseline, post-treatment, 6 mo follow-up	No
Secondary	Risky Driving Inventory		baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu	No
Secondary	South Oaks Gambling Screen		baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu	No