Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01615367
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : April 27, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Louisa Grandin Sylvia, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 31, 2012
First Posted Date  ICMJE June 8, 2012
Results First Submitted Date  ICMJE February 26, 2018
Results First Posted Date  ICMJE April 27, 2018
Last Update Posted Date June 7, 2018
Actual Study Start Date  ICMJE May 21, 2012
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • NEW Tx Scale [ Time Frame: 20 weeks ]
    NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
  • 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. The scale for this item is a 4-point Likert scale ranging from 1 ("poor") to 4 ("excellent"). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
  • 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.
Change History Complete list of historical versions of study NCT01615367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • 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. The score for each domain is summed for a total score that ranges from 4 to 20 with higher scores indicating worse 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. The score for each item is summed for a total score that ranges from 0 to 60 with higher scores indicating more severe 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. The score for each item is summed for a total score that ranges from 0 to 56 with higher scores indicating more severe current manic symptoms.
  • Body Mass Index (BMI) [ Time Frame: 20 weeks ]
    Body Mass Index levels at post-treatment.
  • Weekly Exercise Duration [ Time Frame: 20 weeks ]
    Weekly exercise duration reported at post-treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
Official Title  ICMJE Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: NEW Tx
    25 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.
    Intervention: Other: Nutrition, Exercise, and Wellness (NEW) psychotherapy
  • 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.
    Intervention: Drug: Typically consists of at least one FDA-approved mood stabilizer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2012)
30
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01615367
Other Study ID Numbers  ICMJE K23MH091182-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Louisa Grandin Sylvia, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP