Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
NCT ID: NCT04667520
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
214 participants
INTERVENTIONAL
2021-05-10
2026-06-30
Brief Summary
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Detailed Description
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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. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 \& 2, 5 \& 6, and again at weeks 11 \& 12.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LPA+Fitbit
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
Lifestyle Physical Activity (LPA)
This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.
Fitbit Only
Participants in this group are provided with a Fitbit to collect activity data
Fitbit Only
Participants are provided with a Fitbit during their study participation.
Interventions
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Lifestyle Physical Activity (LPA)
This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.
Fitbit Only
Participants are provided with a Fitbit during their study participation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Butler Hospital
OTHER
Responsible Party
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Principal Investigators
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Ana Abrantes, PhD
Role: PRINCIPAL_INVESTIGATOR
Butler Hospital
Locations
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Butler Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Ana M Abrantes, Ph.D.
Role: primary
Julie Desaulniers, M.S.
Role: backup
Other Identifiers
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202006-001
Identifier Type: -
Identifier Source: org_study_id
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