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

Phase 1

Completed

Conditions: Bipolar Disorder

Interventions: Other: Nutrition, Exercise, and Wellness (NEW) psychotherapy
Drug: Typically consists of at least one FDA-approved mood stabilizer

Registration Number: NCT01615367

Lead Sponsor: Massachusetts General Hospital

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 38

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEW Tx	Nutrition, Exercise, and Wellness (NEW) psychotherapy	25 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.
Treatment as usual (TAU)	Typically consists of at least one FDA-approved mood stabilizer	25 people will be randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire-8	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.
NEW Tx Scale	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.

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale	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.
LIFE- Range of Impaired Functioning Tool	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.
Young Mania Rating Scale	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)	20 weeks	Body Mass Index levels at post-treatment.
Weekly Exercise Duration	20 weeks	Weekly exercise duration reported at post-treatment.