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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
Must not have
a history of psychotic disorder or current psychotic symptoms
current mania
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had a psychotic disorder or current symptoms.
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I am currently experiencing a manic episode.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
131 Previous Clinical Trials
16,294 Total Patients Enrolled
31 Trials studying Depression
6,175 Patients Enrolled for Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
839 Previous Clinical Trials
1,083,434 Total Patients Enrolled
26 Trials studying Depression
7,962 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
~26 spots leftby Jun 2025
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