Transforming Recovery Through Exercise and Community
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The primary aim of this study is to develop a feasible, acceptable, and effective multilevel
      physical activity (PA) intervention that addresses both individual and interpersonal factors
      that can be easily scalable and delivered in the context of a methadone clinic. To do so, the
      investigators will train methadone maintenance treatment (MMT) patients who are already
      engaging in PA at public health recommended levels to deliver a group-based PA intervention
      to physically inactive MMT patients at a large community-based methadone clinic. Through the
      development of interpersonal relationships and social support, the investigators expect that
      MMT peers who have successfully navigated challenges associated with PA in this population
      (i.e. depression, smoking, triggers for drug use in environment) will help physically
      inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.
    

Detailed description: 
      Opioid Use Disorders (OUDs) are a highly prevalent and costly public health concern in the
      United States, with over 2.59 million Americans qualifying for abuse or dependence of opioids
      in 2015. Methadone maintenance treatment (MMT), involving daily distribution of methadone at
      regulated clinics, is the most common treatment for opioid use disorder. While MMT has been
      effective in helping OUD patients improve their quality of life, the overwhelming majority of
      these patients continue to engage in unhealthy lifestyles (e.g., physical inactivity and
      cigarette smoking) that lead to significant physical and mental health morbidities. For
      example, patients in MMT have much higher rates of cardiovascular disease, diabetes,
      hypertension, obesity, depression, sleep difficulties, and cognitive impairments than
      age-matched controls, which lead to premature death. Given the mental health, physical
      health, and drug use related benefits of physical activity (PA), interventions targeting
      increases in PA in patients receiving MMT could have a significant impact on reducing their
      overall morbidity and mortality.

      To date, few PA studies have been conducted with substance abusing populations - and, only
      one small pilot study with MMT patients. The goal of this project is to develop a feasible,
      acceptable and effective multilevel PA intervention that addresses both individual and
      interpersonal factors that can be easily scalable and delivered in the context of a health
      care setting (i.e., methadone clinics). To do so, the investigators are proposing to train
      MMT patients who are already engaging in PA at public health recommended levels to deliver a
      group-based PA intervention to physically inactive MMT patients at SSTAR Lifeline, a large
      community-based methadone clinic in Fall River, Massachusetts. Peer-facilitated interventions
      for self-management skills are common in the care of patients with chronic medical
      conditions. Peers may play a particularly important role in increasing physical activity in
      MMT, as this population faces unique and significant barriers to PA (e.g., depression,
      smoking, minimal social supports). Through the development of interpersonal relationships,
      the investigators expect that MMT peers who have successfully navigated these challenges will
      help physically inactive MMT patients increase self-efficacy and motivation for initiating
      and sustaining PA.

      The aims of the study include:

        1. PHASE 1 (Peer-PA Manual Development):

             -  To develop a theoretically-informed peer-facilitated PA plus Fitbit
                (Peer-PA+Fitbit) intervention specific to SSTAR Lifeline, in order to help patients
                in MMT increase levels of physical activity.

                  1. Focus groups will be conducted with: 1) MMT patients who are currently
                     physically active and 2) MMT patients who are NOT meeting recommended PA
                     levels to help inform intervention development.

                  2. The investigators will: (1) develop a manualized Peer-PA intervention (that
                     includes the use of a Fitbit activity monitor for self-monitoring PA and
                     additional social networking), (2) create a training protocol for MMT patients
                     to become peer-facilitators, and (3) identify safe, walkable paths in
                     participant neighborhoods.

        2. PHASE 2 (Open Pilot):

             -  An open pilot trial will be conducted with 20 MMT patients to determine the
                feasibility, acceptability, and short term increases in PA of the Peer-PA+Fitbit
                intervention. At the end of 3 months:

                  1. Feedback will be obtained on Peer-PA+Fitbit from both the MMT peers and
                     participants through self-report measures and qualitative interviews.

                  2. Adherence to the intervention will be determined through group attendance and
                     Fitbit data.

                  3. Short-term increases in physical activity levels will be examined through
                     objectively measured PA.

        3. PHASE 3 (Randomized Clinical Trial; RCT)

      To conduct a 3-arm preliminary RCT of Peer-PA+Fitbit compared to Fitbit Only and compared to
      Usual Care (UC) among 150 MMT patients. We hypothesize that, Peer-PA+Fitbit will be superior
      to Fitbit Only and that Fitbit Only will be superior to UC on the following:

        1. Higher levels of short-term (3-month) and long-term (6- and 12-month)
           objectively-measured steps/day and moderate-to-vigorous physical activity (MVPA)

        2. Fewer days of drug use and lower levels of depression and anxiety symptoms at each
           follow-up

        3. Higher levels of theoretically-relevant, PA-related variables including: self-efficacy,
           internal motivation, and social support at 3- and 6-month follow-ups
    

Intervention name(s): Peer-Facilitated Counseling; Fitbit activity tracker
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will engage in a 12-week physical activity intervention guided by a peer-facilitator at the methadone clinic they receive treatment. Participants will attend weekly groups, engage in a guided walking group, and utilize the Fitbit to self-monitor physical activity.; Participants will be given a Fitbit activity tracker to monitor physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Activity; Peer-facilitation; Methadone Maintenance Therapy