Status:
RECRUITING
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Lead Sponsor:
Butler Hospital
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Depression
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04667520
Start Date
May 10 2021
End Date
June 30 2026
Last Update
April 6 2025
Active Locations (1)
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1
Butler Hospital
Providence, Rhode Island, United States, 02906