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Completed
NCT04667520
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Conditions: Alcohol Use Disorder, Depression
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 176
Sponsor: Butler Hospital
Location: Butler Hospital Providence Rhode Island
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04667520). StuddyBuddy aggregates publicly available trial information.