Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
NEW Tx
1 other identifier
interventional
38
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2012
CompletedFirst Submitted
Initial submission to the registry
May 31, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedResults Posted
Study results publicly available
April 27, 2018
CompletedJune 7, 2018
May 1, 2018
4.8 years
May 31, 2012
February 26, 2018
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
NEW Tx Scale
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 only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
20 weeks
Client Satisfaction Questionnaire-8
Client Satisfaction Questionnaire-8 is a reliable and valid self-report of participants' acceptability of treatment. This is an assessment of client/patient satisfaction with their care and perceived quality and tolerability of NEW Tx. The scale for this item is a 4-point Likert scale ranging from 1 ("poor") to 4 ("excellent"). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
20 weeks
Secondary Outcomes (5)
LIFE- Range of Impaired Functioning Tool
20 weeks
Montgomery Asberg Depression Rating Scale
20 weeks
Young Mania Rating Scale
20 weeks
Body Mass Index (BMI)
20 weeks
Weekly Exercise Duration
20 weeks
Study Arms (2)
NEW Tx
EXPERIMENTAL25 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.
Treatment as usual (TAU)
ACTIVE COMPARATOR25 people will be randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.
Interventions
NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.
Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Eligibility Criteria
You may qualify if:
- Diagnosis of Bipolar Disorder (Type I or II), which is the primary focus of treatment
- Ability to give informed consent
- Currently ill (CGI-BP ≥ 3)
- Age \> 18 years and \< 65 years
- Overweight individuals (BMI \> 25)
You may not qualify if:
- Unwilling/unable to comply with study procedures
- Endorsed item, confirmed by patient's physician, on the PAR-Q
- Euthymic (CGI-BP \< 3)
- Diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa) in the past month
- Diagnosis of substance dependence in the past month
- Active suicidality (MADRS item 9 score \> 4)
- Pregnant (as analyzed by a urine pregnancy test)
- Currently receiving another psychosocial treatment
- Exercising regularly (i.e., 5 days per week for 30 min)
- Neurologic disorder or history of head trauma
- Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Louisa Sylvia
- Organization
- Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor of Psychiatry
Study Record Dates
First Submitted
May 31, 2012
First Posted
June 8, 2012
Study Start
May 21, 2012
Primary Completion
February 28, 2017
Study Completion
February 28, 2017
Last Updated
June 7, 2018
Results First Posted
April 27, 2018
Record last verified: 2018-05