Combined intervention approaches for initiating and maintaining physical activity in depressed individuals: design and rationale of the Project MOVE randomized clinical trial

Introduction: Regular engagement in physical activity decreases risks for many chronic conditions, and may also improve depression symptoms. However, rates of physical activity and adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals. Methods: This is a study protocol for Project MOVE. This study is a theoretically-driven, 3-arm randomized controlled trial for increasing physical activity with depressed adults. Each successive arm includes an added component that may serve to increase and maintain physical activity. The arms are: 1) Brief advice (BA) to exercise alone (minimal treatment control condition); 2) BA + supervised and home-based exercise (SHE) + health education (HE; serves as contact control for CBEX); and 3) BA + SHE +cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX). The target sample size is 240. Assessments are conducted at baseline, Month 1.5, end of intervention (month 3), and at 6 and 9 months. The primary outcome is minutes of moderate-to-vigorous physical activity, assessed via an accelerometer. Secondary outcomes include cardiorespiratory fitness, body composition, and depression, and maintenance of moderate-vigorous physical activity through 6 and 9 month follow-ups. Mediators and moderators derived from behavior change theories, including the Health Behavior Model, Self-Determination Theory, and Social Ecological Theory, will be examined. Conclusion: Project MOVE is designed to test primarily whether both a structured exercise program (SHE) and a cognitive-behavioral group (CBEX) increase physical activity in depressed adults during both a 3-month intervention period, and during the 6-months that follow.