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

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407935
• Other study ID #: R34AT011302
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Brown University
• Contact: Lauren C Bohlen, Ph.D.
• Phone: 401-863-6559
• Email: lauren_bohlen[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Physical Inactivity

Intervention

Behavioral:
• ACTivity
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)

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Center for Complementary and Integrative Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Change in Credibility and expectancy questionnaire	Measures perceived credibility and expected benefits of treatment	Week 1 (After the first treatment session)
Other	Change in Client satisfaction questionnaire	Measures satisfaction with treatment	Post-Treatment (8 weeks) and following the booster session (12 weeks)
Other	Change in Group cohesion questionnaire	Measures perceived cohesiveness of the treatment group	Post-Treatment (8 weeks)
Primary	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	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
Secondary	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