LDART: Social Support Intervention for Addiction Recovery

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06022107
Collaborator
Society of Addiction Psychology (Other)
30
1
1
23
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: LDART
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Piloting a Novel Social Support Intervention for Addiction Recovery
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: LDART

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

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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment feasibility [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.

  2. Retention feasibility [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.

  3. Intervention acceptability (engagement with intervention) [Duration of intervention (Days 1-28)]

    Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.

  4. Intervention acceptability (subjective experience) [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.

Secondary Outcome Measures

  1. Change from Baseline in Percent Drinking Days [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.

  2. Change from Baseline in Percent Heavy Drinking Days [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.

  3. Change from Baseline in Hours Spent Engaging with Recovery Support Services [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.

  4. Change from Baseline in Quality of Life [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.

  5. Change from Baseline in Recovery Capital [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 1 Church St New Haven Connecticut United States 06510

Sponsors and Collaborators

  • Yale University
  • Society of Addiction Psychology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT06022107
Other Study ID Numbers:
  • 2000035434
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2023