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

Bipolar Disorder Clinical Trial

— NEW Tx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615367
• Other study ID #: K23MH091182-02
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 21, 2012
• Est. completion date: February 28, 2017

Study information

• Verified date: May 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEW Tx Scale	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.	20 weeks
Primary	Client Satisfaction Questionnaire-8	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.	20 weeks
Secondary	LIFE- Range of Impaired Functioning Tool	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.	20 weeks
Secondary	Montgomery Asberg Depression Rating Scale	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.	20 weeks
Secondary	Young Mania Rating Scale	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.	20 weeks
Secondary	Body Mass Index (BMI)	Body Mass Index levels at post-treatment.	20 weeks
Secondary	Weekly Exercise Duration	Weekly exercise duration reported at post-treatment.	20 weeks