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Clinical Trials/NCT04667520
NCT04667520
Recruiting
N/A

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

Butler Hospital1 site in 1 country214 target enrollmentMay 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Butler Hospital
Enrollment
214
Locations
1
Primary Endpoint
Percent of sample that is abstinent from alcohol
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2021
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Percent of sample that is abstinent from alcohol

Time Frame: 12 months

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

Secondary Outcomes

  • Depressive symptoms(12 months)
  • Alcohol Abstinence Self-Efficacy(12 months)
  • Cardiorespiratory Fitness (estimated peak VO2)(12 months)
  • Alcohol-Related Consequences(12 months)
  • Physical Activity levels(12 months)

Study Sites (1)

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