- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02705898
Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women
August 1, 2019 updated by: Butler Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LPA+Fitbit
A 12-week LPA+Fitbit intervention for depressed women in intensive alcohol treatment.
This will include: 1) a single in-person physical activity (PA) counseling orientation session; 2) 6 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 email.
|
|
Active Comparator: Health Education Contact Control (HEC)
The HEC condition will include: 1) an in-person orientation session, 2) 6 telephone-delivered health education sessions, and 3) weekly health-related e-mails.
A variety of health and lifestyle topics will be addressed including the following: Session 1 (week 1) - Nutrition-What to Eat and What Not to Eat; Session 2 (week 2) - Sleep Problems and Sleep Hygiene; Session 3 (week 4) - Alcohol Use among Women; Session 4 (week 6) - Relaxation training; Session 5 (week 8) - Time Management and Assertiveness; and Session 6 (week 10) - Being a Smart Patient when Coordinating your Healthcare.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent days abstinent
Time Frame: 6-months
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Level of depressive symptoms as measured by the Quick Inventory of Depressive Symptomatology (QIDS)
Time Frame: 6-months
|
6-months
|
Steps/day as measured by the actigraphy
Time Frame: 6-months
|
6-months
|
Positive coping scores on the Brief COPE measure
Time Frame: 6-months
|
6-months
|
Level of motivation for abstinence using the Contemplation Ladder
Time Frame: 6-months
|
6-months
|
Level of self-efficacy on the Alcohol Abstinence Self-Efficacy Scale
Time Frame: 6-months
|
6-months
|
estimated VO2 max on the 6-minute Astrand-Rhyming Cycle Test
Time Frame: 6-months
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 11, 2016
Study Record Updates
Last Update Posted (Actual)
August 5, 2019
Last Update Submitted That Met QC Criteria
August 1, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1507-001
- R34AA024038 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Dependence
-
University Hospital, LilleCompleted
-
Tel-Aviv Sourasky Medical CenterMinistry of Health, IsraelUnknownAlcohol-dependenceIsrael
-
Pop Test Oncology LLCBaylor College of Medicine; Michael E. DeBakey VA Medical Center; Congressionally... and other collaboratorsCompletedPotential Treatment for Alcohol Dependence-Alcohol InteractionUnited States
-
DynamiCare HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA); RANDActive, not recruitingAlcohol Dependence | Alcohol Use Disorder | Drug DependenceUnited States
-
National Institute on Alcohol Abuse and Alcoholism...CompletedAlcohol Abuse | Alcohol Dependence (Primary Condition)United States
-
University Hospital, Gentofte, CopenhagenCompleted
-
Massachusetts General HospitalCompletedAlcohol Dependence | Drug Abuse | Alcohol Abuse | Drug DependenceUnited States
-
University of WashingtonU.S. Army Medical Research and Development CommandCompletedAlcohol Dependence | Substance Abuse | Alcohol Abuse | Substance DependenceUnited States
-
Anders Fink-Jensen, MD, DMSciThe Novavì outpatient clinics, Copenhagen; Neurobiology Research Unit, Rigshospitalet... and other collaboratorsCompletedAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
-
Psychiatric Centre RigshospitaletThe Novavì outpatient clinics, CopenhagenRecruitingAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
Clinical Trials on LPA+Fitbit
-
Butler HospitalActive, not recruitingPregnancy | CannabisUnited States
-
Butler HospitalRecruiting
-
Butler HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDepression | Alcohol Use DisorderUnited States
-
Boston UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingHIV | Physical Inactivity | Unhealthy Alcohol UseUnited States
-
Women and Infants Hospital of Rhode IslandCompletedOvarian Cancer | brca1 Mutation Carrier | brca2 Mutation CarrierUnited States
-
Ohio State UniversityNational Institute of Nursing Research (NINR); National Institutes of Health...CompletedCardiovascular Diseases | Physical Activity | Kidney Transplant; Complications | Cardiorenal; ChangeUnited States
-
Hospices Civils de LyonRecruitingRheumatoid ArthritisFrance
-
The London Spine CentreUnknownLumbar Degenerative Spinal StenosisCanada
-
University of South CarolinaCompletedArthroplasty, Replacement, KneeUnited States
-
Arizona State UniversityCompleted