Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment (HEART)
Primary Purpose
Alcohol Use Disorder, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Physical Activity (LPA)
Fitbit Only
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Butler HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LPA+Fitbit
Fitbit Only
Arm Description
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
Participants in this group are provided with a Fitbit to collect activity data
Outcomes
Primary Outcome Measures
Percent of sample that is abstinent from alcohol
Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.
Secondary Outcome Measures
Alcohol-Related Consequences
The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period.
Depressive symptoms
Symptoms of depression, as measured by the Patient Health Questionnaire-9
Physical Activity levels
Objectively measured steps/day with a Fitbit
Alcohol Abstinence Self-Efficacy
Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale
Cardiorespiratory Fitness (estimated peak VO2)
Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test
Full Information
NCT ID
NCT04667520
First Posted
November 12, 2020
Last Updated
February 14, 2023
Sponsor
Butler Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04667520
Brief Title
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Acronym
HEART
Official Title
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LPA+Fitbit
Arm Type
Experimental
Arm Description
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data
Arm Title
Fitbit Only
Arm Type
Active Comparator
Arm Description
Participants in this group are provided with a Fitbit to collect activity data
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Physical Activity (LPA)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit Only
Intervention Description
Participants are provided with a Fitbit during their study participation.
Primary Outcome Measure Information:
Title
Percent of sample that is abstinent from alcohol
Description
Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Alcohol-Related Consequences
Description
The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period.
Time Frame
12 months
Title
Depressive symptoms
Description
Symptoms of depression, as measured by the Patient Health Questionnaire-9
Time Frame
12 months
Title
Physical Activity levels
Description
Objectively measured steps/day with a Fitbit
Time Frame
12 months
Title
Alcohol Abstinence Self-Efficacy
Description
Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale
Time Frame
12 months
Title
Cardiorespiratory Fitness (estimated peak VO2)
Description
Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test
Time Frame
12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study enrolls females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Abrantes, PhD
Phone
401-455-6652
Email
ana_abrantes@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Herman, PhD
Phone
401-455-6652
Email
dherman@butler.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Abrantes, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Abrantes, Ph.D.
Phone
401-455-6440
First Name & Middle Initial & Last Name & Degree
Julie Desaulniers, M.S.
Phone
401-455-6219
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
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