Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/29/2018
Start Date:September 2015
End Date:July 31, 2019

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Technology-Supported Physical Activity Intervention for Depressed Alcoholic Women

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.

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.

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
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Ana M. Abrantes, Ph.D.
Phone: 401-455-6440
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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