Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

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.
    

Intervention name(s): LPA+Fitbit; HEC
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol use disorders; physical activity; women's health