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

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

  • Alcohol Use Disorder
  • Depression

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.