Social Support Intervention for Addiction Recovery

Alcohol; Harmful Use Clinical Trial

— LDART  

Official title:

Piloting a Novel Social Support Intervention for Addiction Recovery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06022107
• Other study ID #: 2000035434
• Secondary ID: 000
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol
• Alcohol; Harmful Use
• Behavior, Addictive

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.

Locations

Country	Name	City	State
United States	1 Church St	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Society of Addiction Psychology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	One-month post-intervention (Day 56)
Primary	Intervention acceptability (engagement with intervention)	Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.	Duration of intervention (Days 1-28)
Primary	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.	Post-intervention (Day 28)
Secondary	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.	Day 0, 28, and 56
Secondary	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.	Day 0, 28, and 56
Secondary	Change from Baseline in Hours Spent Engaging with Recovery Support Services	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.	Day 0, 28, and 56
Secondary	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.	Day 0, 28, and 56
Secondary	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.	Day 0, 28, and 56