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

Brown University

Status: Completed

Conditions: Physical Inactivity

Treatments: Behavioral: ACTivity; Behavioral: Relaxercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05407935

R34AT011302

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

ACTivity

Experimental group

Description:

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

Treatment:

Behavioral: ACTivity

Relaxercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Relaxercise