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NCT01176825 · ClinicalTrials.gov registry record · Phase 1
Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01176825: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01176825 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01176825, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
Clinician-rated change in mood symptoms and overall functioning
Interventions
- BEHAVIORAL cognitive-behavior therapy (CBT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01176825 record still lists
NCT01176825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which cognitive-behavior therapy (CBT) is the first listed.
NCT01176825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01176825 about?
NCT01176825 is a clinical study titled "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 functi...
What is the current status of trial NCT01176825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2007-09. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01176825?
The interventions under investigation include: cognitive-behavior therapy (CBT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01176825?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176825's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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