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Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

Mass General Brigham logo

Mass General Brigham

Status and phase

Completed
Phase 1

Conditions

Bipolar Disorder

Treatments

Behavioral: cognitive-behavior therapy (CBT)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01176825
R34MH081335 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 24 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

CBT
Experimental group
Description:
14-week individual cognitive-behavior therapy
Treatment:
Behavioral: cognitive-behavior therapy (CBT)
Treatment As Usual
No Intervention group
Description:
14-week waitlist control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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