RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-10
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04667520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * female
  2. * between 18 and 65 years of age
  3. * score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2)
  4. * Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months)
  5. * are currently engaged in alcohol treatment
  6. * own a smartphone - to allow for EMA software and Fitbit application
  1. * current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
  2. * a history of psychotic disorder or current psychotic symptoms
  3. * current suicidality or homicidality
  4. * current mania
  5. * marked organic impairment according to either the medical record or responses to the diagnostic assessments
  6. * 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)
  7. * current pregnancy or intent to become pregnant during the next 12 weeks

Contacts and Locations

Study Contact

Ana Abrantes, PhD
CONTACT
401-455-6652
ana_abrantes@brown.edu
Debra Herman, PhD
CONTACT
401-455-6652
dherman@butler.org

Principal Investigator

Ana Abrantes, PhD
PRINCIPAL_INVESTIGATOR
Butler Hospital

Study Locations (Sites)

Butler Hospital
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: Butler Hospital

  • Ana Abrantes, PhD, PRINCIPAL_INVESTIGATOR, Butler Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-10
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-05-10
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Depression