Phase 2
Completed N=38
Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
Source: ClinicalTrials.gov NCT01615367 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: NEW Tx Scale — 23.54; 37.75 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NEW Tx Scale |
23.54; 37.75 | — |
| PRIMARY Client Satisfaction Questionnaire-8 |
25.77; 23.13 | — |
| SECONDARY LIFE- Range of Impaired Functioning Tool |
9.08; 9.75 | — |
| SECONDARY Montgomery Asberg Depression Rating Scale |
13.11; 12.36 | — |
| SECONDARY Young Mania Rating Scale |
5.42; 5.95 | — |
| SECONDARY Body Mass Index (BMI) |
32.49; 35.76 | — |
| SECONDARY Weekly Exercise Duration |
268.08; 85.42 | — |
Eligibility Criteria
Inclusion Criteria
- 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 25)
Exclusion Criteria
- Unwilling/unable to comply with study procedures
- Endorsed item, confirmed by patient's physician, on the PAR-Q
- Euthymic (CGI-BP 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)
Data sourced from ClinicalTrials.gov (NCT01615367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.