Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder (NEW Tx)
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|ClinicalTrials.gov Identifier: NCT01615367|
Recruitment Status : Active, not recruiting
First Posted : June 8, 2012
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||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|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 28, 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: NEW Tx
25 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)
25 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.
- NEW Tx Scale [ Time Frame: 20 weeks ]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 ]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.
- Framingham Risk Score [ Time Frame: 20 weeks ]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 ]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 ]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 ]Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615367
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|