Initiating and Maintaining Physical Activity in Depressed Individuals
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).

      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:

        1. To compare the efficacy of the 3 arms for increasing physical activity during the
           12-week intervention phase. We 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.

        2. To compare the longer-term impact of the three arms on objectively-measured minutes of
           MVPA at 6- and 9-month follow-ups (i.e., follow-up phase). Hypotheses are the same as
           for the intervention phase (aim #1).

           Secondary Aims:

        3. To assess the impact of proposed intervention combinations on depression, physical
           health outcomes including cardiorespiratory fitness and body composition, and
           self-reported MVPA in all phases. Hypotheses mirror those described in our primary aims
           above.

        4. To determine whether amount of MVPA mediates the association between group assignment
           and change in depressive symptoms. We hypothesize that amount of MVPA will serve as a
           mediator.

        5. To examine behavior change theory-based mediators of the association between group
           assignment and MVPA. Hypothesized mediators include: perceived benefits of exercise,
           perceived barriers to exercise, exercise self-efficacy, intrinsic motivation to
           exercise, and identified motivation to exercise.

        6. To examine whether social and environmental barriers to exercise predict exercise
           maintenance.
    

Intervention name(s): BA (brief advice); SHE (supervised and home-based exercise); HE (health education); CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment