Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Butler Hospital
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Percent of sample that is abstinent from alcohol
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
LPA+Fitbit
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
Intervention: Lifestyle Physical Activity (LPA) (Behavioral)
Fitbit Only
Participants in this group are provided with a Fitbit to collect activity data
Intervention: Fitbit Only (Behavioral)
Outcomes
Primary Outcomes
Percent of sample that is abstinent from alcohol
Time Frame: 12 months
Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.
Secondary Outcomes
- Depressive symptoms(12 months)
- Alcohol Abstinence Self-Efficacy(12 months)
- Cardiorespiratory Fitness (estimated peak VO2)(12 months)
- Alcohol-Related Consequences(12 months)
- Physical Activity levels(12 months)