Clinical trial NCT05407935: Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults with Depressive Symptoms
Official title: Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults with Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-06-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Accelerometry
timeFrame: Baseline, Post-Treatment (8 weeks), 6-months
Secondary outcomes:
measure: Change in Self-report physical activity (Godin)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
measure: Change in Self-reported depression symptoms (CES-D)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
Other outcomes:
measure: Change in Physical activity values clarification (valuing questionnaire)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
measure: Change in Acceptance of physical activity-related distress (Physical Activity Acceptance Questionnaire)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
measure: Change in Physical activity-related motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
measure: Change in Discomfort intolerance (Discomfort Intolerance Scale)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
measure: Change in Physical activity enjoyment (PACES questionnaire)
timeFrame: Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months
measure: Change in Credibility and expectancy questionnaire
timeFrame: Week 1 (After the first treatment session)
measure: Change in Client satisfaction questionnaire
timeFrame: Post-Treatment (8 weeks) and following the booster session (12 weeks)
measure: Change in Group cohesion questionnaire
timeFrame: Post-Treatment (8 weeks)
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University School of Public Health
name: Da M Wil, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: