Physical Inactivity
Conditions
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.
Interventions
BEHAVIORALACTivity
Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
BEHAVIORALRelaxercise
Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Accelerometry | Baseline, Post-Treatment (8 weeks), 6-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-report physical activity (Godin) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Self-reported minutes of leisure time physical activity per week weighted by intensity |
| Change in Self-reported depression symptoms (CES-D) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Score on the Center for Epidemiological Studies Depression Scale (CES-D) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical activity-related motivation (Treatment Self-Regulation Questionnaire - Exercise Version) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Measures the extent to which a person is motivated to engage in physical activity |
| Change in Discomfort intolerance (Discomfort Intolerance Scale) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Measures the extent to which a person can tolerate uncomfortable experiences |
| Change in Physical activity enjoyment (PACES questionnaire) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Measures the extent to which a person enjoys physical activity |
| Change in Client satisfaction questionnaire | Post-Treatment (8 weeks) and following the booster session (12 weeks) | Measures satisfaction with treatment |
| Change in Group cohesion questionnaire | Post-Treatment (8 weeks) | Measures perceived cohesiveness of the treatment group |
| Change in Credibility and expectancy questionnaire | Week 1 (After the first treatment session) | Measures perceived credibility and expected benefits of treatment |
| Change in Physical activity values clarification (valuing questionnaire) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Measures how a person's values align with physical activity |
| Change in Acceptance of physical activity-related distress (Physical Activity Acceptance Questionnaire) | Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months | Measures the extent to which a person can tolerate any distress associated with physical activity |
Countries
United States
Outcome results
None listed