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
Brown University
National Center for Complementary and Integrative Health (NCCIH)
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 |
|---|---|---|
| Accelerometry | Baseline; Post-Treatment (week 8); Month 6 (week 26) | 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 |
|---|---|---|
| Self-report Physical Activity (Godin) | Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26) | Self-reported minutes of leisure time physical activity per week weighted by intensity. |
| Self-reported Depression Symptoms (CES-D) | Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26) | Score on the Center for Epidemiological Studies Depression Scale (CES-D): CESD SCORE , 20 items (Range 0 to 60, higher score = higher depressive symptoms) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDa M Wil, Ph.D.
Brown University School of Public Health
Participant flow
Pre-assignment details
Participants who were randomized into the study were counted as enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.29 Years STANDARD_DEVIATION 10.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex/Gender, Customized Gender Female | 22 Participants |
| Sex/Gender, Customized Gender Male | 0 Participants |
| Sex/Gender, Customized Gender Other | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 3 / 15 | 3 / 13 | 3 / 24 | 3 / 23 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 | 0 / 24 | 0 / 23 |
Outcome results
None listed