Lifestyle Physical Activity Intervention for Women with Depression and Alcohol Use Disorder

This study is testing a program called Lifestyle Physical Activity (LPA) to help women who are in alcohol treatment and also experience depression. The goal is to see if LPA can help prevent them from returning to drinking alcohol. You would either receive the LPA program, which includes counseling and a Fitbit, or just a Fitbit to track your activity. Researchers will compare these two groups to see if the LPA program helps more. To join, you need to be a woman between 18 and 65, have certain depression symptoms, be currently in alcohol treatment, and not be very active. The study aims to enroll 214 women and will measure how many remain abstinent from alcohol after 12 months.

Study design
This is an interventional study that will enroll 214 women. Participants will be randomly assigned to either the Lifestyle Physical Activity (LPA) + Fitbit group or the Fitbit Only control group.
What's involved
You would participate in an orientation session, six telephone counseling sessions (if in the LPA group), and have your activity monitored with a Fitbit. You would also complete follow-up assessments at 6 weeks, 3 months, 6 months, 9 months, and 12 months, along with three 10-day periods of ecological momentary assessment (EMA).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the study, with assessments at 6 weeks, 3 months, 6 months, 9 months, and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04667520

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

Active, Not Recruiting
NAAges 18–65InterventionalTreatment
Butler Hospital
~214 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Lifestyle Physical Activity (LPA)Fitbit Only

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of sample that is abstinent from alcohol
Measured over 12 months
Alcohol Use Disorder
Depression
1 sites across 1 states
Rhode Island1
  • Ana Abrantes, PhD · PRINCIPAL_INVESTIGATOR · Butler Hospital

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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
  • Percent of sample that is abstinent from alcohol12 months

    Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.