Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment (NCT04667520) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
United States214 participantsStarted 2021-05-10
Plain-language summary
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.