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

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.

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

Conditions
-----------------
Alcohol Use Disorder, Depression

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Physical Activity (LPA)
* Behavioral: Fitbit Only


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LPA+Fitbit<br>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)<br>* 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.<br>|
| Active Comparator: Fitbit Only<br>Participants in this group are provided with a Fitbit to collect activity data | Behavioral: Fitbit Only<br>* Participants are provided with a Fitbit during their study participation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of sample that is abstinent from alcohol | Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol-Related Consequences | The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period. | 12 months | 
| Depressive symptoms | Symptoms of depression, as measured by the Patient Health Questionnaire-9 | 12 months | 
| Physical Activity levels | Objectively measured steps/day with a Fitbit | 12 months | 
| Alcohol Abstinence Self-Efficacy | Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale | 12 months | 
| Cardiorespiratory Fitness (estimated peak VO2) | Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test | 12 months |