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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Butler Hospital
Study ID
NCT04667520
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lifestyle Physical Activity (LPA) — BEHAVIORAL
    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 — BEHAVIORAL
    Participants are provided with a Fitbit during their study participation.

Study Details

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.

Key Dates

Start date
May 10, 2021
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LPA+Fitbit
    Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
  • Active Comparator: Fitbit Only
    Participants in this group are provided with a Fitbit to collect activity data

Primary Outcome Measure

Percent of sample that is abstinent from alcohol [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Butler HospitalProvidenceRhode Island02906
Ana M Abrantes, Ph.D.
401-455-6440
Julie Desaulniers, M.S.
401-455-6219

Find similar trials in Providence, RI

By condition
Substance use disorderDepression
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
Butler Hospital· Providence, RI

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