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

Depression Clinical Trial

— HEART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667520
• Other study ID #: 202006-001
• Secondary ID: R01AA028186
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Butler Hospital
• Contact: Ana Abrantes, PhD
• Phone: 401-455-6652
• Email: ana_abrantes[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Depression
• Depressive Disorder

Intervention

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.
• Fitbit Only
Participants are provided with a Fitbit during their study participation.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Depressive symptoms	Symptoms of depression, as measured by the Patient Health Questionnaire-9	12 months
Secondary	Physical Activity levels	Objectively measured steps/day with a Fitbit	12 months
Secondary	Alcohol Abstinence Self-Efficacy	Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale	12 months
Secondary	Cardiorespiratory Fitness (estimated peak VO2)	Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test	12 months