Project MOVE Bipolar

Summary

The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:

1. brief advice (BA) to exercise (control condition);
2. BA + supervised \& home-based exercise (SHE) + health education (HE) contact control; and
3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).

The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness. The investigators will also compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels. The investigators will also compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase.

Conditions

• Bipolar Disorder (BD)

Interventions

BEHAVIORAL

BA

The BA intervention will be conducted in one 45-minute session in the week after randomization. Participants will meet with the exercise physiologist and have a discussion about: public health guidelines for physical activity (i.e., gradual increase to 150 minutes of MVPA per week), physical and mental health benefits of physical activity, components of typical workout (including warm-up, aerobic zone, cool-down, and knowing when to stop), and how to determine exercise intensity (e.g., rate of perceived exertion (RPE) scale, obtaining radial and carotid pulse), the benefits of maintaining a structured schedule of consistent daily routines and a regular sleep schedule to manage depression and mania.

BEHAVIORAL

SHE

Participants assigned to SHE will attend individual aerobic exercise (AE) sessions supervised by an exercise physiologist once a week at the Butler Hospital Fitness Facility. Exercise at the Butler Hospital Fitness Facility will last \~1 hour, and includes: review of self-monitoring logs (5 minutes), warm-up (5-10 mins), AE (beginning at 20 minutes per session with weekly gradual increases based on heart rate monitoring by the exercise physiologist, with the target being the moderate-intensity range of 64-76% of age-predicted maximal heart rate (28) for each participant), cool-down (5-10 minutes), stretching (5 minutes), and exercise plans for the next week (5 minutes). Participants will choose from several types of exercise equipment, including treadmills, recumbent bicycles, and elliptical machines.

BEHAVIORAL

HE

Health education sessions will serve as a contact control for CBEX. Participants will attend individual sessions. After the initial BA session (week 1), sessions will include HE information such as: nutrition; caffeine; colds, germs, and flu; preventing cancer; diabetes; heart health; sleep; complementary and alternative medicine; caffeine; and being a smart patient

BEHAVIORAL

CBEX

Participants in the CBEX condition will participate in a 30-minute individual counseling session focused on teaching cognitive-behavioral skills to help with increasing motivation and adherence to exercise. CBEX targets: 1) anhedonia, amotivation, increased fatigue, and other individual-level barriers associated with major depression; 2) other individual-level determinants of behavior change described by the Health Belief Model and self-determination theory; and 3) social environment and physical environment factors associated with exercise (through social skills coaching and problem-solving training). Each session will begin with a review of personal barriers and facilitators to exercise, and the therapist will assist the patient with using skills learned in CBEX to manage barriers. Sessions will emphasize making personal choices consistent with goals and values, and participants will have menus of options whenever possible. Participants receive a workbook to use for this intervention

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Butler Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-18

Primary Completion

2020-04-02

Completion

2020-04-02

Countries

• United States

Study Locations