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Completed

NCT Number: NCT01176825

Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

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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Key information

Conditions

Bipolar Disorder Alcohol-Related Disorders Alcoholism Behavior Bipolar and Related Disorders Chemically-Induced Disorders Health Behavior Medication Adherence Mental Disorders Mood Disorders Patient Acceptance of Health Care Patient Compliance Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Clinical Global Improvement Scale (CGI)-Improvement

    Time frame: week 5, week 10, week 14, 3 mo fu, 6 mo fu

    Clinician-rated change in mood symptoms and overall functioning

  2. feasibility and acceptability

    Time frame: post-treatment

    We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures

Secondary outcomes

  1. Adapted Y-BOCS

    Time frame: 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

  2. Social Adjustment Scale (SAS)

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

    Assesses social, educational, occupational, and family functioning

  3. Timeline Follow-Back

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

    Assesses alcohol and drug use over the past 30 days.

  4. SCID depression and mania modules

    Time frame: 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.

  5. Medication history and adherence

    Time frame: baseline, post-treatment, 6 month follow-up

    Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization

  6. Adult Suicidal Ideation Questionnaire (ASIQ)

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

    Assesses severity of suicidal thoughts and behaviors

  7. High-Risk Sexual Behaviors

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

  8. Beck Hopelessness Scale

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

  9. Barratt Impulsiveness Scale

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

  10. Self-Control Behavior Schedule

    Time frame: 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

  11. Hamilton Depression Scale (HAM-D)

    Time frame: 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

  12. Young Mania Rating Scale

    Time frame: 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.

  13. Treatment Satisfaction Questionnaire

    Time frame: post-treatment

    Assesses participants' satisfaction with the treatment received

  14. Urine Toxicology Screen

    Time frame: baseline, post-treatment, 6 mo follow-up

  15. Risky Driving Inventory

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

  16. South Oaks Gambling Screen

    Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2010
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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