Alcohol Use Disorder, Depression
Conditions
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.
Interventions
BEHAVIORALLifestyle 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.
BEHAVIORALFitbit Only
Participants are provided with a Fitbit during their study participation.
Sponsors
Butler Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of sample that is abstinent from alcohol | 12 months | Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol-Related Consequences | 12 months | The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period. |
| Depressive symptoms | 12 months | Symptoms of depression, as measured by the Patient Health Questionnaire-9 |
| Physical Activity levels | 12 months | Objectively measured steps/day with a Fitbit |
| Alcohol Abstinence Self-Efficacy | 12 months | Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale |
| Cardiorespiratory Fitness (estimated peak VO2) | 12 months | Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAna Abrantes, PhD
Butler Hospital
Outcome results
None listed