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Lifestyle Physical Activity for Depression and Alcoholism (HEART Trial)

N/A
Recruiting
Led By Ana Abrantes, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
own a smartphone - to allow for EMA software and Fitbit application
between 18 and 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

HEART Trial Summary

This trial is testing whether a physical activity intervention using a Fitbit can help prevent relapse among women with depression in alcohol treatment.

Who is the study for?
This trial is for women aged 18-65 with depression who are currently in alcohol treatment, own a smartphone, and lead a sedentary lifestyle (less than 150 minutes of moderate exercise per week). They must score at least 5 on the PHQ-9 depression scale. Women can't join if they have certain medical conditions, severe substance use disorders, current pregnancy or intent to become pregnant soon.Check my eligibility
What is being tested?
The study is testing whether a Lifestyle Physical Activity (LPA) program supported by technology like Fitbit helps prevent relapse in these women. Participants will be randomly placed into two groups: one doing LPA with Fitbit and another using only the Fitbit.See study design
What are the potential side effects?
Since this trial involves physical activity and monitoring via Fitbit without any medication or invasive procedures, side effects may include typical exercise-related issues such as muscle soreness or strain.

HEART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I own a smartphone compatible with health tracking apps.
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I am between 18 and 65 years old.

HEART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of sample that is abstinent from alcohol
Secondary outcome measures
Alcohol Abstinence Self-Efficacy
Alcohol-Related Consequences
Cardiorespiratory Fitness (estimated peak VO2)
+2 more

HEART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LPA+FitbitExperimental Treatment1 Intervention
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
Group II: Fitbit OnlyActive Control1 Intervention
Participants in this group are provided with a Fitbit to collect activity data

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,204 Total Patients Enrolled
31 Trials studying Depression
6,175 Patients Enrolled for Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,297 Total Patients Enrolled
25 Trials studying Depression
7,855 Patients Enrolled for Depression
Ana Abrantes, PhDPrincipal InvestigatorButler Hospital
2 Previous Clinical Trials
301 Total Patients Enrolled
1 Trials studying Depression
240 Patients Enrolled for Depression

Media Library

Lifestyle Physical Activity (LPA) Clinical Trial Eligibility Overview. Trial Name: NCT04667520 — N/A
Depression Clinical Trial 2023: Lifestyle Physical Activity (LPA) Highlights & Side Effects. Trial Name: NCT04667520 — N/A
Depression Research Study Groups: LPA+Fitbit, Fitbit Only
Lifestyle Physical Activity (LPA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04667520 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total population of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is seeking participants and was initially posted on May 10th 2021 with the latest update made on July 7th 2022. A total of 214 patients must be recruited from one site only."

Answered by AI

Who meets the requirements for participating in this experiment?

"This clinical study is recruiting 214 female patients aged 18-65 years old with a PHQ-9 score of at least 5 and either question 1 or 2 scoring 1. Additionally, those interested in participating must possess both a smartphone to access EMA software and Fitbit applications as well as lead generally sedentary/low active lifestyles (with less than 150 minutes of moderate intensity exercise per week for the past 3 months)."

Answered by AI

Does the eligibility criteria for this test extend to individuals beneath forty years of age?

"This trial is open to individuals aged 18-65. For those below age of majority and above the retirement age, there are 211 trials and 1149 trials respectively that they can join."

Answered by AI

Is enrollment for this research still open?

"Affirmative. The information available on clinicaltrials.gov shows that this medical trial is still taking applicants, having been initially published on May 10th 2021 and most recently updated July 7th 2022. 214 participants are expected to enroll at a single site for the study."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
What site did they apply to?
Butler Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
2021. "Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04667520.
All > Alcoholism
~61 spots leftby Jun 2025
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