NCT04667520 Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
| NCT ID | NCT04667520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Butler Hospital |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2021-05-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2021-05-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Ana Abrantes, PhD
PRINCIPAL INVESTIGATOR
Butler Hospital
Frequently Asked Questions
Who can join the NCT04667520 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04667520 currently recruiting?
Yes, NCT04667520 is actively recruiting participants. Contact the research team at ana_abrantes@brown.edu for enrollment information.
Where is the NCT04667520 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT04667520 clinical trial?
NCT04667520 is sponsored by Butler Hospital. The principal investigator is Ana Abrantes, PhD at Butler Hospital. The trial plans to enroll 214 participants.