NCT04667520

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

5.1 years

First QC Date

November 12, 2020

Last Update Submit

June 26, 2026

Conditions

Alcohol Use DisorderDepression

Outcome Measures

Primary Outcomes (1)

  • Percent of sample that is abstinent from alcohol

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

    12 months

Secondary Outcomes (5)

  • Alcohol-Related Consequences

    12 months

  • Depressive symptoms

    12 months

  • Physical Activity levels

    12 months

  • Alcohol Abstinence Self-Efficacy

    12 months

  • Cardiorespiratory Fitness (estimated peak VO2)

    12 months

Study Arms (2)

LPA+Fitbit

EXPERIMENTAL

Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data

Behavioral: Lifestyle Physical Activity (LPA)

Fitbit Only

ACTIVE COMPARATOR

Participants in this group are provided with a Fitbit to collect activity data

Behavioral: Fitbit Only

Interventions

Lifestyle Physical Activity (LPA)BEHAVIORAL

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.

LPA+Fitbit
Fitbit OnlyBEHAVIORAL

Participants are provided with a Fitbit during their study participation.

Fitbit Only

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study enrolls females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

AlcoholismDepression

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ana Abrantes, PhD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

December 14, 2020

Study Start

May 10, 2021

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations

US(1)