Alcohol Use DisorderHEARTNCT04667520
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
A study testing Lifestyle Physical Activity (LPA) and Fitbit Only in people with Alcohol Use Disorder and Depression, run by Butler Hospital at 1 site in United States.
Trial summary
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Alcohol Use Disorder, Depression
- What is being tested?
- Lifestyle Physical Activity (LPA) and Fitbit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 30 Jun 2026
- 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
- female
- between 18 and 65 years of age
- score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2)
- Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months)
- are currently engaged in alcohol treatment
- own a smartphone - to allow for EMA software and Fitbit application
Who cannot join
- current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
- a history of psychotic disorder or current psychotic symptoms
- current suicidality or homicidality
- current mania
- marked organic impairment according to either the medical record or responses to the diagnostic assessments
- physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician)
- current pregnancy or intent to become pregnant during the next 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.
Read the detailed description
Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men. Physical activity (PA) interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse.
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 \& 2, 5 \& 6, and again at weeks 11 \& 12.
- Conditions
- Alcohol Use Disorder, Depression
- Being tested
- Lifestyle Physical Activity (LPA), Fitbit Only
- Medical subject headings
- Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Physical Activity (LPA)Behavioural
This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.
Fitbit OnlyBehavioural
Participants are provided with a Fitbit during their study participation.
| Study group | Role | What they receive |
|---|---|---|
| LPA+Fitbit | Experimental | Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data Receives: Behavioral: Lifestyle Physical Activity (LPA) |
| Fitbit Only | Active comparator | Participants in this group are provided with a Fitbit to collect activity data Receives: Behavioral: Fitbit Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of drinking alcohol during early recovery (first 3 months)
Timeline Follow-back Interview will be used to determined the likelihood participants drank alcohol on any given day during the time frame assessed.
Measured: 3 months
Secondary outcomes (4)
Likely of drinking alcohol in the first year (12 months)
Timeline Follow-back Interview will be used to determined the likelihood participants drank alcohol on any given day during the time frame assessed.
Measured: 12 months
Alcohol-Related Consequences
The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period.
Measured: 12 months
Depressive symptoms
Symptoms of depression, as measured by the Patient Health Questionnaire-9
Measured: 12 months
Physical Activity levels
Objectively measured steps/day with a Fitbit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start10 May 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ana Abrantes, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667520
- Sponsor's protocol ID
- 202006-001
- Other IDs
- R01AA028186
- Acronym
- HEART
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
- ClinicalTrials.gov ID
- NCT04667520
- Acronym / sponsor ID
- HEART / 202006-001
- Conditions
- Alcohol Use Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.
Detailed description
Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men. Physical activity (PA) interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse.
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 \& 2, 5 \& 6, and again at weeks 11 \& 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPA+Fitbit | Experimental | Behavioral: Lifestyle Physical Activity (LPA)Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data |
| Fitbit Only | Active comparator | Behavioral: Fitbit OnlyParticipants in this group are provided with a Fitbit to collect activity data |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female
- between 18 and 65 years of age
- score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2)
- Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months)
- are currently engaged in alcohol treatment
Key exclusion criteria (7 listed)
- current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
- a history of psychotic disorder or current psychotic symptoms
- current suicidality or homicidality
- current mania
- marked organic impairment according to either the medical record or responses to the diagnostic assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Physical Activity (LPA)This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation. | Behavioural | LPA+Fitbit |
| Fitbit OnlyParticipants are provided with a Fitbit during their study participation. | Behavioural | Fitbit Only |
Primary outcome
Likelihood of drinking alcohol during early recovery (first 3 months)
Time frame: 3 months
Timeline Follow-back Interview will be used to determined the likelihood participants drank alcohol on any given day during the time frame assessed.
4 secondary outcomes
Likely of drinking alcohol in the first year (12 months)
Time frame: 12 months
Alcohol-Related Consequences
Time frame: 12 months
Depressive symptoms
Time frame: 12 months
Physical Activity levels
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Abrantes, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Physical Activity (LPA) and Fitbit Only in people with Alcohol Use Disorder and Depression, 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 6 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 2 Oct 2026. 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?
Likelihood of drinking alcohol during early recovery (first 3 months) (time frame: 3 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 2 Oct 2026.