Testing a physical activity program for women with depression in alcohol treatment
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
NA · Butler Hospital · NCT04667520
This study tests if a physical activity program using a Fitbit can help women with depression who are in alcohol treatment avoid relapse and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Butler Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT04667520 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a technology-supported lifestyle physical activity intervention designed to prevent relapse in women with depression who are undergoing treatment for alcohol use disorder. Participants will be randomly assigned to either an intervention group that receives a lifestyle physical activity program along with a Fitbit device or a control group that only receives the Fitbit. The study will involve follow-up assessments at various intervals, including 6 weeks, 3 months, and up to 12 months, along with ecological momentary assessments to gather real-time data on participants' experiences during early recovery. The goal is to determine if increased physical activity can serve as a beneficial coping strategy for these women.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 65 who are currently engaged in alcohol treatment and have a score of 5 or above on the PHQ-9 indicating depression.
Not a fit: Patients with moderate to severe substance use disorders, current psychotic symptoms, or significant medical issues that prevent safe participation in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide women with depression in alcohol treatment a valuable tool to reduce relapse rates and improve overall mental health.
How similar studies have performed: Other studies have shown promising results for physical activity interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * female * between 18 and 65 years of age * score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2) * Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months) * are currently engaged in alcohol treatment * own a smartphone - to allow for EMA software and Fitbit application Exclusion Criteria: * current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa * a history of psychotic disorder or current psychotic symptoms * current suicidality or homicidality * current mania * marked organic impairment according to either the medical record or responses to the diagnostic assessments * physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician) * current pregnancy or intent to become pregnant during the next 12 weeks
Where this trial is running
Providence, Rhode Island
- Butler Hospital — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Ana Abrantes, PhD — Butler Hospital
- Study coordinator: Ana Abrantes, PhD
- Email: ana_abrantes@brown.edu
- Phone: 401-455-6652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, Depression