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Alcohol DependenceNCT02705898

Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women

A study testing LPA+Fitbit and HEC in people with Alcohol Dependence, run by Butler Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Alcohol Dependence
What is being tested?
LPA+Fitbit and HEC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
Sep 2015to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Butler Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
LPA+Fitbit, HEC
Keywords
alcohol use disorders, physical activity, women's health
Medical subject headings
Alcoholism, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LPA+FitbitBehavioural

  • HECBehavioural

Study groups in NCT02705898
Study groupRoleWhat they receive
LPA+FitbitExperimentalA 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.
Receives: Behavioral: LPA+Fitbit
Health Education Contact Control (HEC)Active comparatorThe 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.
Receives: Behavioral: HEC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent days abstinent

    Measured: 6-months

Secondary outcomes (6)
  1. Level of depressive symptoms as measured by the Quick Inventory of Depressive Symptomatology (QIDS)

    Measured: 6-months

  2. Steps/day as measured by the actigraphy

    Measured: 6-months

  3. Positive coping scores on the Brief COPE measure

    Measured: 6-months

  4. Level of motivation for abstinence using the Contemplation Ladder

    Measured: 6-months

  5. Level of self-efficacy on the Alcohol Abstinence Self-Efficacy Scale

    Measured: 6-months

  6. estimated VO2 max on the 6-minute Astrand-Rhyming Cycle Test

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study startSep 2015
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
RCT
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02705898
Sponsor's protocol ID
1507-001
Other IDs
R34AA024038
Status last verified
Aug 2019
First submitted
29 Feb 2016
Last updated
5 Aug 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing LPA+Fitbit and HEC in people with Alcohol Dependence, run by Butler Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent days abstinent (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.

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