Clinical Trial

Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment

Study acronym: HEART
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 29, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-12-08; most recent amendment 2026-06-26.
Status change: Recruiting → Active, Not Recruiting 2026-06-26
Status change: Not Yet Recruiting → Recruiting 2021-05-14
Trial Details
NCT Number NCT04667520
Lead Sponsor Butler Hospital
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use Disorder, Depression
Enrollment 214 participants
Start Date 2021-05-10
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-29