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

Butler Hospital

Status: Enrolling

Conditions: Depression; Alcohol Use Disorder

Treatments: Behavioral: Lifestyle Physical Activity (LPA); Behavioral: Fitbit Only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04667520

R01AA028186 (U.S. NIH Grant/Contract)

202006-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

LPA+Fitbit

Experimental group

Description:

Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data

Treatment:

Behavioral: Lifestyle Physical Activity (LPA)

Fitbit Only

Active Comparator group

Description:

Participants in this group are provided with a Fitbit to collect activity data

Treatment:

Behavioral: Fitbit Only