MedTrace Logo

Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder

NCT01615367 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-06-07

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

OTHER

Nutrition, Exercise, and Wellness (NEW) psychotherapy

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.

DRUG

Typically consists of at least one FDA-approved mood stabilizer

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-21
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615367 on ClinicalTrials.gov