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

NCT ID: NCT01615367

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-21
• Study Completion Date: 2017-02-28

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.

Detailed Description

The purpose of the Nutrition, Exercise, and Wellness Treatment (NEW Tx) research is to develop and test the feasibility and acceptance of a theoretically integrated treatment to address the impact of medical comorbidity of individuals with bipolar disorder (BD), while exploring its efficacy, whether it improves overall functioning and symptoms, as well as examine a potential moderator and mediator of treatment response.

A.Primary Aims

Aim 1: Feasibility and Acceptance of NEW Tx in the Nonrandomized Trial.

Hypothesis 1a: A preliminary study of whether NEW Tx will be feasible with regards to recruitment, retention, blinded assessments, and therapist adherence to NEW Tx.

Hypothesis 1b: Participants will report high satisfaction with the treatment and acceptability over the study duration in a nonrandomized trial.

Aim 2: Feasibility and Acceptance of NEW Tx and its Evaluation in the Randomized Pilot Trial.

Hypothesis 2a: A pilot study of whether NEW Tx will be feasible with regards to recruitment, randomization, retention, blinded assessments, and therapist adherence to NEW Tx.

Hypothesis 2b: Participants will report high satisfaction with the treatment and acceptability over the study duration in the randomized pilot trial.

B. Exploratory Aims

Aim 3a: Reducing Medical Burden in the Randomized Pilot Trial. Pilot test the efficacy of NEW Tx in improving medical burden using the Framingham Risk Score (FRS).

Hypothesis 3a: Over the course of 20-weeks (18 sessions) the NEW Tx group will have a lower FRS compared to treatment as usual (TAU) in the randomized pilot trial.

Aim 3b: Symptoms and Functioning in the Randomized Pilot Trial. Examine the efficacy of NEW Tx in improving functioning and symptoms of BD.

Hypothesis 3b: Over the course of 20-weeks (18 sessions) the NEW Tx group will improved functioning and mood symptoms compared to TAU in the randomized pilot trial.

Aim 3c: Moderator and Mediator of NEW Tx in the Randomized Pilot Trial. Investigate a potential moderator and mediator of treatment response.

Hypothesis 3c.1: Individuals with higher baseline Body Mass Index (BMI) > 30 will moderate the between treatment effect size for medical burden (FRS) in the randomized pilot trial, such that of NEW Tx will have lower FRSs.

Hypothesis 3c.2: Mastery of the diet and exercise modules of NEW Tx will mediate the association of NEW Tx and improvement in medical burden (FRS).

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NEW Tx

25 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.

Group Type: EXPERIMENTAL

Nutrition, Exercise, and Wellness (NEW) psychotherapy

Intervention Type: OTHER

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.

Treatment as usual (TAU)

25 people will be randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.

Group Type: ACTIVE_COMPARATOR

Typically consists of at least one FDA-approved mood stabilizer

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

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 < 65 years
• Overweight individuals (BMI > 25)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Louisa Grandin Sylvia

Instructor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23MH091182-02

Identifier Type: NIH

Identifier Source: org_study_id

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