This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

Lifestyle Intervention

Sponsor:

Butler Hospital

Code:

NCT04667520

Conditions

Alcohol Use Disorder

Depression

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Lifestyle Physical Activity (LPA)

Fitbit Only

Study Details

Brief 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

Alcohol Use Disorder

Depression

Study ID

NCT04667520

Start date

May 10, 2021

Status verified date

Jun, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Fitbit Only

Participants are provided with a Fitbit during their study participation.

Primary outcome measure

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

Central Contacts and Locations

More Information

Sponsor

Butler Hospital

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Butler Hospital on 2026-06-29.