Plain-English translation of NCT04667520 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is testing whether a lifestyle physical activity intervention—combined with a wearable activity tracker called a Fitbit—can help women with depression who are undergoing treatment for alcohol use disorder. The trial will follow 214 women over one year to see if exercise helps prevent relapse and improves overall health outcomes.
Women with alcohol use disorder often struggle with depression and face high rates of relapse. Exercise and physical activity may offer a new coping tool and a healthier way to manage emotions during recovery, but this benefit hasn't been thoroughly tested in women in this situation.
You would be randomly assigned to one of two groups: one that receives a guided exercise program plus a Fitbit tracker, or another that receives only the Fitbit tracker. Over one year, you'll have follow-up visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months. You'll also complete brief surveys on your phone about your daily activities and feelings during three 10-day periods early in your recovery. The program is designed to fit into your ongoing alcohol treatment.
AI-generated summary from trial data · Jun 30, 2026 · Not medical advice
United States
Sponsor
Butler Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Enrollment target
~214 participants
Started
May 2021
Primary completion
June 2026
Age range
18 Years – 65 Years
Sex
Female only
Last updated on clinicaltrials.gov in June 2026.