Early phase clinical trial to test the feasibility of an ACT-based physical activity promotion program for adults with depressive symptoms

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ABSTRACT Up to 25% of U.S. adults have clinically significant depressive symptoms5,6 and people who experience these symptoms are at increased risk of all-cause mortality7 and chronic disease8-23 Engaging in regular physical activity (PA) can help alleviate depressive symptoms27-31 and reduce risk of chronic diseases, such as CVD32-36 and type 2 diabetes,37-41 that are associated with depression. Despite the benefits of PA for those with depressive symptoms, depressive symptoms consistently predict PA nonadherence.42-45 Factors such as decreased distress tolerance46-52 and low motivation53-60 make adherence to regular PA particularly difficult for adults with depressive symptoms. Thus, an important problem that needs to be addressed is how to help adults with depressive symptoms overcome barriers to regular PA. Acceptance and Commitment Therapy (ACT)61,62 is a mindfulness-informed intervention that is efficacious for fostering behavior change in various healthy populations and for treating depression. ACT enhances motivation for functional activities in depressed individuals by helping them to clarify personal values consistent with behavioral goals, and foster present- moment, nonjudgmental awareness (i.e., mindfulness) and acceptance of internal experiences to increase distress tolerance. These foci of ACT may be applied to address the intolerance of negative affective response to PA and low motivation for PA that serve as barriers to regular PA among adults with depressive symptoms. The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based ACTivity to PA+Education among 60 low-active adults (ages 18-65) with elevated depressive symptoms at two Greater Providence YMCA branches. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities. Aim 1: Develop and demonstrate training and intervention fidelity procedures for bachelor’s level interventionists to direct the ACTivity and PA+Education interventions. Aim 2: Demonstrate feasibility of recruitment, randomization, retention, and data collection procedures to conduct an individually randomized group treatment trial (IRGT). Aim 3: Demonstrate credibility (i.e., how convincing and logical a treatment seems) and acceptability of the ACTivity and PA+Education programs. Impact: The proposed research is a necessary step to prepare for a future multi-site RCT that has the potential to change clinical practice guidelines if shown to be effective. Specifically, if shown to be effective, ACTivity will provide a community- based treatment that can be delivered at local YMCAs by bachelor’s level staff to increase MVPA among depressed adults and thereby decrease their risk for chronic disease.