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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Louisa Grandin Sylvia, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01615367
First received: May 31, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Other: Nutrition, Exercise, and Wellness (NEW) psychotherapy
Drug: Typically consists of at least one FDA-approved mood stabilizer
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • NEW Tx Scale [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx at Baseline and their acceptability of NEW Tx at Week 10 and Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx.

  • Client Satisfaction Questionnaire-8 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Framingham Risk Score [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Framingham Risk Score (FRS) will be used to estimate medical burden as it is designed to estimate risk in adults (age > 20) to predict 10-year risk for myocardial infarction and coronary death. The FRS is calculated based on six indices: age, gender, total cholesterol, HDL cholesterol, smoker (Y/N), systolic blood pressure, and medications to treat high blood pressure (Y/N).

  • LIFE- Range of Impaired Functioning Tool [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    LIFE- Range of Impaired Functioning Tool assesses the extent to which medical burden has impacted current functioning.

  • Montgomery Asberg Depression Rating Scale [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Montgomery Asberg Depression Rating Scale is a 10-item clinician-rated measure of depression that assesses the presence and severity of patient's current depressive symptoms.

  • Young Mania Rating Scale [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEW Tx
15 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.
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.
Active Comparator: Treatment as usual (TAU)
15 people will be randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615367

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Margaret Gigler, BA    617-726-0997    mgigler@mgh.harvard.edu   
Principal Investigator: Louisa Sylvia, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Louisa Grandin Sylvia, Instructor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01615367     History of Changes
Other Study ID Numbers: K23MH091182-02
Study First Received: May 31, 2012
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Bipolar disorder
Nutrition
Exercise
Symptoms
Functioning

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 11, 2014