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

NCT04667520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Fitbit Only

Participants are provided with a Fitbit during their study participation.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Ana Abrantes, PhD · Butler Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667520 on ClinicalTrials.gov