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

Running, not enrolling · Not applicable

Conditions studied: Alcohol Use Disorder, Depression

In brief

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 facts

Study ID: NCT04667520
Run by: Butler Hospital
People needed: 214
Starts: 2021-05-10
Expected to finish: 2026-06-30
Last updated by the study team: 2026-06-29

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

female
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

You may not qualify if…

current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
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

Where it is running

Butler Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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