Clinical trial NCT04667520: Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Official title: Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Depression
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-12-14
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of sample that is abstinent from alcohol
timeFrame: 12 months
Secondary outcomes:
measure: Alcohol-Related Consequences
timeFrame: 12 months
measure: Depressive symptoms
timeFrame: 12 months
measure: Physical Activity levels
timeFrame: 12 months
measure: Alcohol Abstinence Self-Efficacy
timeFrame: 12 months
measure: Cardiorespiratory Fitness (estimated peak VO2)
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Ana Abrantes, PhD
role: PRINCIPAL_INVESTIGATOR
References: