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

Abstract Introduction Regular engagement in physical activity (PA) decreases risks for many chronic conditions, and there is growing evidence showing a positive impact of this behavior on the reduction of depression symptoms. However, rates of PA as well as adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals. Methods Project MOVE is a theoretically-driven, 3-arm randomized controlled trial with depressed adults comparing three 12-week interventions, each with varying levels of intensity in promoting and supporting adherence to a regular exercise regimen: 1) brief advice (BA) to exercise only; 2) BA + supervised and home-based exercise (SHE) + cognitive behavioral sessions (CBEX); and BA+SHE + health education (HE). Assessments are conducted at baseline, 6 weeks, end of intervention (week 12), and at 6 and 9 months. The primary outcome is minutes of moderate-to-vigorous physical activity (MVPA), objectively assessed by accelerometry data. Secondary outcomes include cardiorespiratory fitness, body composition, and depression, and maintenance of MVPA through 6 and 9 month follow-ups. Moreover, 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 whether BA + SHE + CBEX is superior to BA + SHE + HE, and whether BA + SHE + HE will be superior to BA alone in increasing MVPA levels among adults with depression. This trial will provide much needed data on the effect of combined intervention components on prolonged engagement with PA among depressed adults.