Social Support Intervention for Addiction Recovery (LDART)

• ClinicalTrials.gov Identifier: NCT06022107
• Recruitment Status: Active, not recruiting
• First Posted: September 1, 2023
• Last Update Posted: May 6, 2024
• Sponsor: Yale University
• Collaborator: Society of Addiction Psychology
• Information provided by (Responsible Party): Yale University

Tracking Information

• First Submitted Date: August 23, 2023
• First Posted Date: September 1, 2023
• Last Update Posted Date: May 6, 2024
• Actual Study Start Date: January 26, 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2023)

• Recruitment feasibility [ Time Frame: Baseline ]
  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 [ Time Frame: One-month post-intervention (Day 56) ]
  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) [ Time Frame: Duration of intervention (Days 1-28) ]
  Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.
• Intervention acceptability (subjective experience) [ Time Frame: Post-intervention (Day 28) ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2024)

• Change from Baseline in Percent Drinking Days [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  Self-reported total number of hours spent engaging in recovery support services (e.g., being at a recovery community center, attending a support group meeting) in the past 28-day time window for two consecutive windows.
• Change from Baseline in Quality of Life [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  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.

Original Secondary Outcome Measures (submitted: August 30, 2023)

• Change from Baseline in Percent Drinking Days [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  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 [ Time Frame: Day 0, 28, and 56 ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Social Support Intervention for Addiction Recovery
• Official Title: Piloting a Novel Social Support Intervention for Addiction Recovery
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Alcohol; Harmful Use
• Alcohol

Intervention

Behavioral: LDART

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.

Study Arms

Experimental: LDART

Participants will be asked to log onto the LDART website each night for a month.

Intervention: Behavioral: LDART

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 30, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 years of age or older
• Is at the time of study participation residing in Connecticut, USA
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06022107
• Other Study ID Numbers: 2000035434; 000 ( Other Identifier: CTGTY )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Yale University
• Original Responsible Party: Same as current
• Current Study Sponsor: Yale University
• Original Study Sponsor: Same as current
• Collaborators: Society of Addiction Psychology

Investigators

• Principal Investigator: Marc N Potenza, MD, PhD; Yale University
• Principal Investigator: Li Yan McCurdy, PhD; Yale University

• PRS Account: Yale University
• Verification Date: May 2024