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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Lifestyle Physical Activity (LPA); Behavioral: Fitbit Only

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 Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Abrantes, PhD; Phone Number: 401-455-6652; Email: ana_abrantes@brown.edu
• Study Contact Backup: Name: Debra Herman, PhD; Phone Number: 401-455-6652; Email: dherman@butler.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Butler Hospital
      • Contact: Ana M Abrantes, Ph.D.; Phone Number: 401-455-6440
      • Contact: Julie Desaulniers, M.S.; Phone Number: 401-455-6219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LPA+Fitbit; 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); 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.
Active Comparator: Fitbit Only; Participants in this group are provided with a Fitbit to collect activity data	Behavioral: Fitbit Only; Participants are provided with a Fitbit during their study participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Ana Abrantes, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Mood Disorders; Alcoholism; Depression; Depressive Disorder
• Other Study ID Numbers: 202006-001; R01AA028186 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No