Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms

Study Overview
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Brief Summary
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The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 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.

Official Title
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Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms

Conditions
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Physical Inactivity

Intervention / Treatment
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* Behavioral: ACTivity
* Behavioral: Relaxercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated depressive symptoms (CES-D score of greater than or equal to 10) Low-active (less than 60 minutes per week of moderate intensity PA) Willing and able to attend weekly virtual video sessions via Zoom Exclusion Criteria: Regular mindfulness meditation practice (more than once per week) Body Mass Index (BMI) less than 18.5 or greater than 40 History or presence of any condition that may limit or substantially increase the risks of physical activity Active suicidal thoughts or behaviors Currently participating in any exercise or weight-loss research studies Household member is participating in this study Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box Unable to receive materials in the mail at residential mailing address Does not plan to live in Rhode Island for the next 6 months Unable to speak, read, and/or write fluently in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTivity<br>Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) | Behavioral: ACTivity<br>* Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)<br>|
| Active Comparator: Relaxercise<br>Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring) | Behavioral: Relaxercise<br>* Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Accelerometry | Minutes of physical activity weighted by intensity, expressed in metabolic equivalent (MET) minutes per week as determined by accelerometers (Actigraph [model wGT3x-BT]) worn during one-week periods. | Baseline, Post-Treatment (8 weeks), 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-report physical activity (Godin) | Self-reported minutes of leisure time physical activity per week weighted by intensity | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | 
| Change in Self-reported depression symptoms (CES-D) | Score on the Center for Epidemiological Studies Depression Scale (CES-D) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months |