Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

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).
    

Intervention name(s): Nutrition, Exercise, and Wellness (NEW) psychotherapy; Typically consists of at least one FDA-approved mood stabilizer
Intervention type(s): Other; Drug
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Nutrition; Exercise; Symptoms; Functioning