Clinical trial NCT02705898: Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women
Official title: Technology-Supported Physical Activity Intervention for Depressed Alcoholic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: alcohol use disorders
physical activity
women's health
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-03-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Alcohol use disorders (AUDs) are the 3rd leading preventable cause of death in the U.S. and are associated with significant economic burden and health-related negative consequences. While women may be less likely to develop AUDs, they experience more significant negative health consequences of alcohol use than men. Due to stigma, shame, and child care issues; women are less likely to receive specialty addiction treatment. The comorbidity of depression and AUDs is much higher in women, and compared to men, women depression often has a temporal onset prior to an AUD. Relapse rates are very high in both men and women but significant gender differences emerge in the predictors of relapse. Women are more likely to relapse in unpleasant, negative emotional states and depressive symptoms and negative affect mediate the relationship between these stressors and drinking outcomes. More so than men, women with AUDs report drinking to cope with negative emotions. Therefore, intervention approaches that help women develop alternate coping strategies can have an important role in decreasing alcohol relapse among depressed women with AUDs. Given the demonstrated benefits of exercise for decreasing depression, negative affect, and urges to drink, helping women engage in a flexible and acceptable lifestyle physical activity (LPA) intervention may provide them a tool they can utilizing "in the moment" to cope with negative emotional states and alcohol craving during early recovery when relapse risk is highest. Exciting new digital fitness technologies (e.g., Fitbit activity monitor with web and mobile applications) have emerged in recent years that include features able to further enhance critical components for increasing physical activity - goal setting and self-monitoring. The investigators propose to develop a 12-week LPA+Fitbit intervention for depressed women in alcohol treatment. This will include: 1) an in-person physical activity (PA) counseling orientation session; 2) 4 brief, phone-based PA counseling sessions focused on increasing PA and strategically using bouts of PA to cope with affect and alcohol cravings; 3) use of the Fitbit fitness tracker for physical activity goal-setting and daily self-monitoring; and 4) weekly supportive messages delivered by text message. The overall objective of this application is to develop this LPA+Fitbit intervention, modify it based on a initial open pilot (n=20) and feedback to ensure its feasibility and acceptability for depressed women with AUDs in early recovery, propose potential mechanisms, and to obtain preliminary data on its efficacy in a small randomized clinical trial (n=50). The LPA+Fitbit intervention proposed in this application is simple, low-cost, and easily transportable to the varied clinical settings women with AUDs receive treatment. If women with AUDs find the LPA+Fitbit intervention feasible, acceptable, and helpful during early recovery, they could be afforded with a much needed alternate coping strategy that would reduce relapse risk and decrease the overall negative impact of alcohol use on their health and well-being.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent days abstinent
timeFrame: 6-months
Secondary outcomes:
measure: Level of depressive symptoms as measured by the Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: 6-months
measure: Steps/day as measured by the actigraphy
timeFrame: 6-months
measure: Positive coping scores on the Brief COPE measure
timeFrame: 6-months
measure: Level of motivation for abstinence using the Contemplation Ladder
timeFrame: 6-months
measure: Level of self-efficacy on the Alcohol Abstinence Self-Efficacy Scale
timeFrame: 6-months
measure: estimated VO2 max on the 6-minute Astrand-Rhyming Cycle Test
timeFrame: 6-months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: