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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LPA+Fitbit
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
  • Behavioral: Lifestyle Physical Activity (LPA)
    This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.
Active Comparator
Fitbit Only
Participants in this group are provided with a Fitbit to collect activity data
  • Behavioral: Fitbit Only
    Participants are provided with a Fitbit during their study participation.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Butler Hospital

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.