NCT04667520

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Butler Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder
• Depression

Interventions

Type	Name	Description
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.
BEHAVIORAL	Fitbit Only	Participants are provided with a Fitbit during their study participation.

Timeline

• Start date: 2021-05-10
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2020-12-14
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States