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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Inactivity
• Intervention / Treatment: Behavioral: ACTivity; Behavioral: Relaxercise

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren C Bohlen, Ph.D.; Phone Number: 401-863-6559; Email: lauren_bohlen@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Brown University
      • Contact: Lauren Connell Bohlen, PhD; Phone Number: 401-863-6559; Email: lauren_bohlen@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical activity values clarification (valuing questionnaire)	Measures how a person's values align with physical activity	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Change in Acceptance of physical activity-related distress (Physical Activity Acceptance Questionnaire)	Measures the extent to which a person can tolerate any distress associated with physical activity	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Change in Physical activity-related motivation (Treatment Self-Regulation Questionnaire - Exercise Version)	Measures the extent to which a person is motivated to engage in physical activity	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Change in Discomfort intolerance (Discomfort Intolerance Scale)	Measures the extent to which a person can tolerate uncomfortable experiences	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Change in Physical activity enjoyment (PACES questionnaire)	Measures the extent to which a person enjoys physical activity	Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Change in Credibility and expectancy questionnaire	Measures perceived credibility and expected benefits of treatment	Week 1 (After the first treatment session)
Change in Client satisfaction questionnaire	Measures satisfaction with treatment	Post-Treatment (8 weeks) and following the booster session (12 weeks)
Change in Group cohesion questionnaire	Measures perceived cohesiveness of the treatment group	Post-Treatment (8 weeks)

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Da M Wil, Ph.D., Brown University School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R34AT011302 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No