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Could a fitbit and phone coaching help women with depression stay sober?

NCT ID NCT04667520

Disease control Sponsor: Butler Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether a lifestyle physical activity program, supported by a Fitbit and phone counseling, can help women with depression who are in alcohol treatment reduce their risk of relapse. Participants are randomly assigned to either receive the full program or just a Fitbit. The goal is to see if increasing daily movement can improve sobriety, mood, and overall well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lifestyle Physical Activity (LPA) program with Fitbit monitoring
What this could lead to
If effective, this approach could offer a low-cost, non-drug way to help women with depression reduce alcohol relapse and improve mental health.
What could go wrong
The trial is relatively small and tests a behavioral intervention, which may not work for everyone. Results depend on participant motivation and adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

alcohol abuse Depression depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder Depression

Contacts and locations

Locations

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.