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

Study acronym: HEART
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Trial completed
    • Final enrollment: 176 participants (planned 214)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 5 to 4
    • Study description revised
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  3. Primary completion date: Jun 30, 2025 to Jun 30, 2026v8
  4. Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    v7
  5. Collaborators expanded, about 8 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2024
    • Start date: Apr 19, 2021 to May 10, 2021
    v4
  3. Secondary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 1, 2021 to Apr 19, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Butler Hospital
30 trials monitored
See 1 trial at risk
Depression
3,055 trials monitored
See 173 trials at risk
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.
Trial Details
NCT Number NCT04667520
Lead Sponsor Butler Hospital
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Use Disorder, Depression
Related terms Alcoholism, Depression
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov