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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Depression
• Interventions: Behavioral: Lifestyle Physical Activity (LPA); Behavioral: Fitbit Only

• Registration Number: NCT04667520
• Lead Sponsor: Butler Hospital

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.

Detailed Description

Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men. Physical activity (PA) interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse.

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. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 \& 2, 5 \& 6, and again at weeks 11 \& 12.

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-14
• Study Start: 2021-05-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 214

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPA+Fitbit	Lifestyle Physical Activity (LPA)	Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
Fitbit Only	Fitbit Only	Participants in this group are provided with a Fitbit to collect activity data

Primary Outcome Measures

Name	Time	Method
Percent of sample that is abstinent from alcohol	12 months	Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	12 months	Symptoms of depression, as measured by the Patient Health Questionnaire-9
Alcohol Abstinence Self-Efficacy	12 months	Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale
Cardiorespiratory Fitness (estimated peak VO2)	12 months	Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test
Alcohol-Related Consequences	12 months	The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period.
Physical Activity levels	12 months	Objectively measured steps/day with a Fitbit

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States