Exercise, Mood and Stress Study
Condition: Anxiety; Post-Traumatic Stress Disorder; Depression
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple studies indicate that exercise is effective in treating depressed mood and reducing
      anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in
      individuals with anxiety and depressive disorders, exercise could help reduce these symptoms
      and aid in the overall treatment of these disorders. This project aims to test an ecological
      momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in
      individuals with anxiety or depressive disorders. Previous protocols have tested the
      acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the
      study, focus groups were conducted to explore the acceptability and usability of the
      Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app
      based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6
      healthy participants. Preliminary unpublished findings indicate that the app was acceptable
      and promoted increased physical activity. The aim of this protocol is to test the
      acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood
      in patients with anxiety or depressive disorders.
    

Detailed description: 
      Design: A multiple baseline design will be employed: the intervention will be introduced in
      the 1st participant after a baseline period of 8 days, in the 2nd participant after 11 days,
      and in the 3rd participant after 15 days. The same pattern will be followed for participants
      4-6. Participants will be in the intervention period for 21 days, 18 days, and 14 days
      respectively, at a prescription of 150 minutes of moderate intensity

      Screening Visit:

      Individuals who pass the phone screen will be invited to come to our laboratory for remaining
      screening procedures. At the screening visit, in-person assessment will include informed
      consent procedures, evaluation of psychiatric inclusion/exclusion criteria and mood, anxiety
      and traumatic stress disorders with the Anxiety Disorders Interview Schedule for Diagnostic
      and Statistical Manual of Mental Disorders (DSM) 5 Adult Version (ADIS-5) and additional
      informal assessment if needed (e.g. to assess eating disorders). The diagnostic assessment
      will be performed by a study staff member who has been trained in administration of the
      ADIS-5 and clinical interviewing. If a diagnostic assessment has been conducted at the Center
      for Anxiety and Related Disorders (CARD) at Boston University within the last six weeks,
      participants will be given the option to provide consent for it to be used instead (plus
      additional portions of the ADIS-5 if needed). Eligible participants will be assigned to one
      of the three conditions above (as this is a single case design, it is not randomized;
      participants are assigned sequentially to the conditions above). The Screening Visit, which
      will last 1 hour, may take place on the same or a different day as the pre-baseline visit
      depending on the researcher and participant's availability.

      Pre-Baseline Visit (Day 1):

      This in-person visit will occur on Day 1 before the baseline recording period and last 45
      minutes. Participants will complete baseline questionnaires and a Physical Activity Recall
      interview (PAR). Participants' height and weight will be collected. Participants will be
      given a tutorial on and be provided with an activity and heart monitoring device to wear.
      Participants will be instructed to engage in their normal level of activity until their next
      visit. They will be instructed to wear an activity monitor during all waking hours and a
      heart rate monitor if they exercise. They will be scheduled for a Pre-Intervention Visit
      either 8, 11, or 15 days later (depending on assignment above).

      Pre-Intervention Visit (Day 8, 11, 15 for Participants 1, 2, and 3, respectively):

      This in-person visit will occur after the baseline recording period and last 45 minutes.
      Participants will be prescribed the Exercise4Mood Mobile Intervention for a period 21, 18, or
      14 days (depending on assignment above) at a prescription of 150 minutes of moderate
      intensity (i.e. 64 percent to 76 percent of your maximum heart rate, typically achieved with
      a brisk walk) exercise per week (as defined by American College of Sports Medicine (ACSM)
      guidelines).

      During this visit, they will complete an introduction to Exercise4Mood. This will involve
      meeting with the PI who will provide a broad overview of the intervention and training on how
      to download and use the Exercise4Mood app (and a number to call in case of technical
      difficulties). Participants will be provided with a Subject ID number and password that they
      will use to log in to the Exercise4Mood app. They will self-select what days and times they
      would like to exercise. The PI will help problem solve and ensure that their self-selected
      plan is feasible. The PI will note down the days and times so that text-message reminders can
      be sent to the participant. Participants will complete a Physical Activity Recall interview
      (PAR). Participants will leave the visit with the Exercise4Mood app downloaded on their
      personal phone and an exercise schedule for the next 21, 18, or 14 days.

      Intervention Period (21, 18, or 14 days):

      In the two days following the Pre-Intervention Visit, participants will be prompted to
      complete the Introduction to Exercise4Mood app modules at home. During these modules, they
      will be provided with information about getting started with exercising. This will include a
      list of different types of moderate intensity exercise (as listed below) from which
      participants will self-select what type of exercise they would like to engage in over the
      intervention period.

        -  Walking briskly

        -  Biking slowly

        -  Jogging

        -  Swimming leisurely

        -  Elliptical or other gym machines

        -  Stair walking

        -  Basketball

        -  Aerobic Yoga

        -  Tennis

        -  Catch/throw sports (e.g. baseball)

      During the intervention period, participants will receive text message prompts to engage with
      the Exercise4Mood app and engage in exercise. At the end of each week that they are in the
      intervention, they will be prompted to complete questionnaires through the Exercise4Mood app.
      These questionnaires will take approximately 15 minutes to complete. During this period, they
      will wear an activity monitor during all waking hours and a heart rate monitor when they are
      exercising.

      Endpoint Visit (Day 29):

      On Day 29, participants will complete an in-person 30 minute visit. During this visit, they
      will complete an interview about their physical activity engagement, questionnaires (if they
      did not completed them on the app the day prior), and return the activity and heart rate
      monitor. Participants will be provided with referrals for mental health treatment.
    

Intervention name(s): Exercise4Mood Intervention
Intervention type(s): Behavioral
Intervention description(s): The Exercise4Mood Intervention was designed based on principles from the Exercise for Mood and Anxiety protocol (Smits et al., 2009) and consists primarily of a mobile application called Exercise4Mood. It will be supported by text-messages, delivered through SymTrend, reminding participants about their scheduled exercise sessions and prompting them to engage with the app. Its core features include: motivational tips to encourage exercise, reminders about scheduled exercise, tracking of exercise behavior, tracking of mood before, during, and after exercise, and post-exercise positive reinforcement statements.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other