Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women

Completed · Not applicable

Conditions studied: Alcohol Dependence

In brief

Building on the large body of evidence for the effect of exercise in decreasing depressive symptoms and the few preliminary findings of its effect on craving and drinking outcomes, the purpose of this study is to develop a lifestyle physical activity (LPA) intervention that harnesses the technological advantages of the Fitbit tracker (plus its web and mobile platforms) for depressed women with alcohol use disorders (AUDs). The intervention will provide women with an acceptable, flexible and effective alternate coping strategy during early recovery, when relapse risk is highest. The overall objective of this work is to fully develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to ensure its feasibility and acceptability for depressed women with AUDs in early recovery, propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.

Key facts

Study ID

NCT02705898

Run by

Butler Hospital

People needed

70

Starts

2015-09-01

Expected to finish

2019-07-31

Last updated by the study team

2019-08-05

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• currently engaged in alcohol treatment
• meets criteria for DSM-5 alcohol use disorder
• score of 1 on ONE of the first 2 items of the Patient Health Questionnaire (PHQ-9)
• less than 150 minutes of moderate-intensity aerobic exercise per week over the last 6 months
• has access to a computer connected to the internet or a smartphone compatible with the Fitbit application

You may not qualify if…

• current DSM-5 diagnosis of moderate/severe substance use disorder, anorexia, or bulimia
• history of psychotic disorder or current psychotic symptoms
• current suicidality or homicidality
• current mania
• marked organic impairment
• physical or medical problems that would not allow safe participation in exercise
• currently pregnant or intending to be pregnant in the next 12 weeks

Where it is running

• Butler Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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