Social Support Intervention for Addiction Recovery (LDART)
Primary Purpose
Alcohol; Harmful Use, Alcohol
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LDART
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol; Harmful Use
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Is fluent in English and has a 6th grade reading level or higher Alcohol Use Disorders Identification Test (AUDIT) score of ≥8 Has had at least one heavy drinking day in the past month Has some desire to cut down or quit their alcohol use Has a smartphone or computer with access to internet Exclusion Criteria: Has vulnerable population status (e.g., pregnant people, prisoners) Is at the time of study participation receiving in-patient psychiatric treatment involving hospitalization
Sites / Locations
- 1 Church St
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LDART
Arm Description
Participants will be asked to log onto the LDART website each night for a month.
Outcomes
Primary Outcome Measures
Recruitment feasibility
Feasibility of recruitment is measured as the number of adults who consent to study participation divided by the number of months the trial recruits for.
Retention feasibility
Retention rate is calculated as the number of participants who complete the study divided by the number of participants who consented to participating in the study.
Intervention acceptability (engagement with intervention)
Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.
Intervention acceptability (subjective experience)
Acceptability is measured with a 9-item self-report acceptability assessment questionnaire. This comprises questions regarding the motivational and supportive properties of the content, perceptions on the frequency of engaging with the intervention, and whether they enjoyed using the intervention. Each question is rated on a 5-point Likert scale, where higher values indicate greater acceptability. There will also be two open-ended questions for participants to indicate what they liked and did not like about the intervention and ways to improve it.
Secondary Outcome Measures
Change from Baseline in Percent Drinking Days
Timeline Follow Back is a validated, self-reported instrument that provides specific dates for alcohol use in the past 28 days, and the number of standard drinks consumed on each drinking day. Percent Drinking Days is calculated as the number of days in the 28-day window in which one or more standard drinks is consumed for two consecutive windows.
Change from Baseline in Percent Heavy Drinking Days
Percent Heavy Drinking Days is calculated from the Timeline Follow Back instrument as the number of days in the 28-day window in which four/five or more standard drinks is consumed for women/men for two consecutive windows.
Change from Baseline in Hours Spent Engaging with Recovery Support Services
The Timeline Follow Back instrument will be used to quantify number of hours spent engaging in recovery support services (e.g., being at a recovery community center, attending a support group meeting) each day in the past 28-day time window for two consecutive windows.
Change from Baseline in Quality of Life
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a 26-item questionnaire with four domains (score range in parentheses): physical health (7-35), psychological health (6-30), social relationships (3-15), and environment (8-40). Each question is rated on a five-point Likert scale, where higher values indicate higher quality of life.
Change from Baseline in Recovery Capital
Brief Assessment of Recovery Capital (BARC) is a 10-item self-report measure of recovery capital with ten domains (substance use and sobriety, global psychological health, global physical health, citizenship and community involvement, social support, meaningful activities, housing and safety, risk-taking, coping and life functioning, recovery experience). Each item is rated in binary, so domain scores range from 0-5, and total score ranges from 0-10, where higher values indicate higher recovery capital.
Full Information
NCT ID
NCT06022107
First Posted
August 23, 2023
Last Updated
August 30, 2023
Sponsor
Yale University
Collaborators
Society of Addiction Psychology
1. Study Identification
Unique Protocol Identification Number
NCT06022107
Brief Title
Social Support Intervention for Addiction Recovery
Acronym
LDART
Official Title
Piloting a Novel Social Support Intervention for Addiction Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Society of Addiction Psychology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to determine whether using a web-based intervention is feasible, acceptable, and helpful for people who engage in hazardous alcohol use and want to cut down or quit.
Detailed Description
This pilot study will determine the feasibility and acceptability of a novel online social support intervention (Let's Do Addiction Recovery Together!, abbreviated as LDART) that uses pre-recorded videos created by members of recovery support services to help individuals in early recovery from hazardous alcohol use sustain motivation during recovery and introduce them to freely available recovery support services in the community. The investigators will recruit participants to use the web-based intervention daily for a month; they will also fill in questionnaires about their substance use and engagement with recovery support services at the beginning and end of the study to determine preliminary efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Harmful Use, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LDART
Arm Type
Experimental
Arm Description
Participants will be asked to log onto the LDART website each night for a month.
Intervention Type
Behavioral
Intervention Name(s)
LDART
Intervention Description
LDART is a newly developed web-based social support intervention that can be accessed by smartphone or computer. Each night, the participant sets a recovery goal for the next day (e.g., drink less than usual, go to a support group meeting). The next night, they log on to LDART to indicate whether they reached their goal for the day. Depending on their response, they will be shown either a celebratory or encouraging message from someone in the addiction recovery community, along with specific information on that person's recovery organization.
Primary Outcome Measure Information:
Title
Recruitment feasibility
Description
Feasibility of recruitment is measured as the number of adults who consent to study participation divided by the number of months the trial recruits for.
Time Frame
Baseline
Title
Retention feasibility
Description
Retention rate is calculated as the number of participants who complete the study divided by the number of participants who consented to participating in the study.
Time Frame
One-month post-intervention (Day 56)
Title
Intervention acceptability (engagement with intervention)
Description
Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.
Time Frame
Duration of intervention (Days 1-28)
Title
Intervention acceptability (subjective experience)
Description
Acceptability is measured with a 9-item self-report acceptability assessment questionnaire. This comprises questions regarding the motivational and supportive properties of the content, perceptions on the frequency of engaging with the intervention, and whether they enjoyed using the intervention. Each question is rated on a 5-point Likert scale, where higher values indicate greater acceptability. There will also be two open-ended questions for participants to indicate what they liked and did not like about the intervention and ways to improve it.
Time Frame
Post-intervention (Day 28)
Secondary Outcome Measure Information:
Title
Change from Baseline in Percent Drinking Days
Description
Timeline Follow Back is a validated, self-reported instrument that provides specific dates for alcohol use in the past 28 days, and the number of standard drinks consumed on each drinking day. Percent Drinking Days is calculated as the number of days in the 28-day window in which one or more standard drinks is consumed for two consecutive windows.
Time Frame
Day 0, 28, and 56
Title
Change from Baseline in Percent Heavy Drinking Days
Description
Percent Heavy Drinking Days is calculated from the Timeline Follow Back instrument as the number of days in the 28-day window in which four/five or more standard drinks is consumed for women/men for two consecutive windows.
Time Frame
Day 0, 28, and 56
Title
Change from Baseline in Hours Spent Engaging with Recovery Support Services
Description
The Timeline Follow Back instrument will be used to quantify number of hours spent engaging in recovery support services (e.g., being at a recovery community center, attending a support group meeting) each day in the past 28-day time window for two consecutive windows.
Time Frame
Day 0, 28, and 56
Title
Change from Baseline in Quality of Life
Description
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a 26-item questionnaire with four domains (score range in parentheses): physical health (7-35), psychological health (6-30), social relationships (3-15), and environment (8-40). Each question is rated on a five-point Likert scale, where higher values indicate higher quality of life.
Time Frame
Day 0, 28, and 56
Title
Change from Baseline in Recovery Capital
Description
Brief Assessment of Recovery Capital (BARC) is a 10-item self-report measure of recovery capital with ten domains (substance use and sobriety, global psychological health, global physical health, citizenship and community involvement, social support, meaningful activities, housing and safety, risk-taking, coping and life functioning, recovery experience). Each item is rated in binary, so domain scores range from 0-5, and total score ranges from 0-10, where higher values indicate higher recovery capital.
Time Frame
Day 0, 28, and 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Is fluent in English and has a 6th grade reading level or higher
Alcohol Use Disorders Identification Test (AUDIT) score of ≥8
Has had at least one heavy drinking day in the past month
Has some desire to cut down or quit their alcohol use
Has a smartphone or computer with access to internet
Exclusion Criteria:
Has vulnerable population status (e.g., pregnant people, prisoners)
Is at the time of study participation receiving in-patient psychiatric treatment involving hospitalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yan McCurdy, PhD
Phone
2036518748
Email
liyan.mccurdy@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc N Potenza, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Yan McCurdy, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
1 Church St
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yan McCurdy, PhD
Phone
203-651-8748
Email
liyan.mccurdy@yale.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Social Support Intervention for Addiction Recovery
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