Providence, Rhode Island 02906

  • Depression

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT04667520


Primary Contact:

Principal Investigator
Ana Abrantes, PhD
Butler Hospital

Ana Abrantes, PhD
Phone: 401-455-6652
Email: ana_abrantes@brown.edu


Backup Contact:

Email: dherman@butler.org
Debra Herman, PhD
Phone: 401-455-6652


Location Contact:

Providence, Rhode Island 02906
United States

Ana M Abrantes, Ph.D.
Phone: 401-455-6440

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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