Social Support Intervention for Addiction Recovery (LDART)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06022107 |
Recruitment Status :
Recruiting
First Posted : September 1, 2023
Last Update Posted : February 7, 2024
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Condition or disease | Intervention/treatment | Phase |
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Alcohol; Harmful Use Alcohol | Behavioral: LDART | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 |
Actual Study Start Date : | January 26, 2024 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: LDART
Participants will be asked to log onto the LDART website each night for a month.
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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. |
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022107
Contact: Li Yan McCurdy, PhD | 203-456-7456 | liyan.mccurdy@yale.edu |
United States, Connecticut | |
1 Church St | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact: Li Yan McCurdy, PhD 203-456-7456 liyan.mccurdy@yale.edu |
Principal Investigator: | Marc N Potenza, MD, PhD | Yale University | |
Principal Investigator: | Li Yan McCurdy, PhD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT06022107 |
Other Study ID Numbers: |
2000035434 000 ( Other Identifier: CTGTY ) |
First Posted: | September 1, 2023 Key Record Dates |
Last Update Posted: | February 7, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Behavior, Addictive Compulsive Behavior Impulsive Behavior |