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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
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 belowSelect...
I own a smartphone compatible with health tracking apps.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had a psychotic disorder or current symptoms.
Select...
I am currently experiencing a manic episode.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreTrial 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
130 Previous Clinical Trials
16,279 Total Patients Enrolled
31 Trials studying Depression
6,175 Patients Enrolled for Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,161,092 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You haven't been physically active or exercising enough in the past 3 months (less than 150 minutes per week of moderate-intensity exercise).You are currently receiving treatment for alcohol addiction.I have never had a psychotic disorder or current symptoms.I own a smartphone compatible with health tracking apps.The PHQ-9 is a questionnaire that can help determine if you have depressionI am currently experiencing a manic episode.You currently have thoughts of harming yourself or others.I am female.I am between 18 and 65 years old.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: LPA+Fitbit
- Group 2: Fitbit Only
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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