Butler Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT02691845
The investigators propose a randomized clinical trial in which 240 depressed individuals 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 in order to prepare for a larger scale randomized clinical trial.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
The investigators propose a randomized clinical trial in which 240 depressed individuals are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
There are two phases for participants: intervention phase (3 months), which consists of intensive contact, and the follow-up phase (6 months). BA will consist of one, 45-minute session about public health recommendations, and strategies for getting started. SHE will be a 12-week intervention consisting of 1x/week supervised exercise plus exercise prescriptions for home-based exercise with the goal of gradually achieving the public health recommendation of 150 minutes/week of moderate-to-vigorous physical activity (MVPA), CBEX and HE sessions will be individual, 30-minute, weekly sessions during the intervention phase. CBEX will address barriers to physical activity that are particularly pronounced in depression -i.e., anhedonia, decreased motivation, and decreased energy, as well as poor problem-solving skills. During the follow-up phase, groups who received SHE during the intervention phase will receive brief, monthly phone check-ins from an exercise specialist.
Primary Aims:
Secondary Aims:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: from baseline to 3 months, 6 months, 9 months
Time frame: Baseline to 3 months, 6 months, 9 months
depression assessed via blind evaluator using the Quick Inventory of Depression Symptoms (QIDS)
Time frame: Baseline to 3 months, 6 months, 9 months
Time frame: Baseline to 3 months, 6 months, 9 months
Time frame: Baseline to 3 months, 6 months, 9 months
Time frame: Baseline to 3 months, 6 months,9 months
Time frame: Baseline to 3 months, 6 months, 9 months
Time frame: 3 months, 6 months, 9 months
Time frame: Baseline to 3 months, 6 months, 9 months
Time frame: Baseline to 3 months, 6 months, 9 months
Butler Hospital
Other
Acronym: Project MOVE
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