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

NCT ID: NCT05407935

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-16
• Study Completion Date: 2025-05-30

Brief Summary

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.

Conditions

Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ACTivity

Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Group Type: EXPERIMENTAL

ACTivity

Intervention Type: BEHAVIORAL

Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Relaxercise

Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Group Type: ACTIVE_COMPARATOR

Relaxercise

Intervention Type: BEHAVIORAL

Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Interventions

ACTivity

Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Intervention Type: BEHAVIORAL

Relaxercise

Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Da M Wil, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University School of Public Health

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R34AT011302

Identifier Type: NIH

Identifier Source: org_study_id

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