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NCT01615367 · ClinicalTrials.gov registry record · Phase 1
Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01615367: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01615367 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615367, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar disorder, yet no empirically validated psychosocial interventions to manage risk factors for CVD in BD have been developed. The purpose of this study is to develop and test the feasibility of an integrated treatment to decrease CVD risk factors, while exploring whether the intervention improves overall functioning and mood symptoms. The designed treatment integrates theories on Nutrition strategies, Exercise interventions, and Wellness Treatment (NEW Tx) to address risk factors for CVD that co-occur with bipolar disorder. NEW Tx includes novel intervention strategies in each of these three modules, as well as modified and tailored empirically-supported strategies for bipolar disorder. The primary hypotheses are that NEW Tx will be feasible to deliver, acceptable to this population, and associated with improvements in CVD risk factors (i.e., waist circumference). Exploratory analyses will examine predictors of treatment response and the effect of NEW Tx on mood symptoms and overall functioning.
Primary Outcome
NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants o
Interventions
- OTHER Nutrition, Exercise, and Wellness (NEW) psychotherapy
- DRUG Typically consists of at least one FDA-approved mood stabilizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-05-21 |
| Est. Completion | 2017-02-28 |
| Phase | Phase 1 |
What the finished NCT01615367 record still lists
NCT01615367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Nutrition, Exercise, and Wellness (NEW) psychotherapy is the first listed.
NCT01615367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01615367 about?
NCT01615367 is a clinical study titled "Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder". Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar disorder, yet no empirically validated psychosocial interventions to manage risk factors for CVD in BD have been developed. The purpose of this study is to develop and test the feasibility of an integrated treatm...
What is the current status of trial NCT01615367?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-05-21. Estimated completion is 2017-02-28.
What interventions are being tested in trial NCT01615367?
The interventions under investigation include: Nutrition, Exercise, and Wellness (NEW) psychotherapy (OTHER), Typically consists of at least one FDA-approved mood stabilizer (DRUG).
Who is sponsoring clinical trial NCT01615367?
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 NCT01615367's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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