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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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| Name | Class |
|---|---|
| Society of Addiction Psychology | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDART | Experimental | Participants will be asked to log onto the LDART website each night for a month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDART | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
| 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) |
| 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. Data reported here reflects percentage of participants who answered "agree" or "strongly agree" to the question: "I would recommend LDART to someone trying to cut down or quit drinking". | Post-intervention (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Drinking Days Per Month | 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 Per Month is calculated as the percentage of days in the 28-day window in which one or more standard drinks is consumed for two consecutive windows. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc N Potenza, MD, PhD | Yale University | Principal Investigator |
| Li Yan McCurdy, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 Church St | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37796784 | Derived | McCurdy LY, Kong G, Krishnan-Sarin S, Kiluk BD, Potenza MN. A non-randomized pilot study protocol of a novel social support intervention for individuals in early recovery from hazardous alcohol use. PLoS One. 2023 Oct 5;18(10):e0292293. doi: 10.1371/journal.pone.0292293. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of the 30 participants who were enrolled in the trial, 4 did not complete the baseline assessments and thus did not begin using the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | LDART | Participants will be asked to log onto the LDART website each night for a month. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants per month | Baseline |
|
56 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Li Yan McCurdy, PhD | Yale University | 2037372912 | liyan.mccurdy@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2024 | Jul 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2024 | Jul 10, 2025 | ICF_001.pdf |
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|
| Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
| Percentage of Heavy Drinking Days Per Month | 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 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
| 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 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
| World Health Organization Quality of Life - Brief Version | World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a questionnaire with 24 items that correspond to four domains: physical health, psychological health, social relationships, and environment. Each question is rated on a five-point Likert scale. Each domain score is transformed based on the lowest possible score to create a modified range of 0-100 for each domain. All four domain scores are then averaged to create a single score on a range of 0-100, where higher values indicate higher quality of life. | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
| Brief Assessment of 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). Total score ranges from 0-50, where higher values indicate higher recovery capital. | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Past-year AUDIT score | Alcohol Use Disorder Identification Test (AUDIT) is a screening tool for hazardous alcohol use. Range of score is from 0-40, where higher scores indicate greater severity. A score of ≥8 indicates hazardous alcohol use. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Retention feasibility was calculated as the number of participants who completed the study (i.e., completed the one-month post-intervention assessment) divided by the number of participants who enrolled in the study. | Posted | Count of Participants | Participants | One-month post-intervention (Day 56) |
|
|
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| Primary | Intervention Acceptability (Engagement With Intervention) | Acceptability is calculated as the number of nights participants login to LDART within the 28-day window. | The one participants who dropped out mid-intervention for higher level of care was excluded from analysis. | Posted | Mean | Standard Deviation | nights | 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. Data reported here reflects percentage of participants who answered "agree" or "strongly agree" to the question: "I would recommend LDART to someone trying to cut down or quit drinking". | Of the 25 participants who completed the intervention, 3 did not complete the acceptability ratings, and 1 participant skipped this question. | Posted | Count of Participants | Participants | Post-intervention (Day 28) |
|
|
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| Secondary | Percentage of Drinking Days Per Month | 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 Per Month is calculated as the percentage of days in the 28-day window in which one or more standard drinks is consumed for two consecutive windows. | 2 of the 25 participants did not have data at the third time point (one month post-intervention) so were excluded from analyses. | Posted | Mean | Standard Deviation | Percentage of days in a month | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
|
|
|
| Secondary | Percentage of Heavy Drinking Days Per Month | 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. | 2 of the 25 participants did not have data at the third time point (one month post-intervention) so were excluded from analyses. | Posted | Mean | Standard Deviation | Percentage of days in a month | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
|
|
|
| Secondary | 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. | 2 of the 25 participants did not have data at the third time point (one month post-intervention) so were excluded from analyses. | Posted | Mean | Standard Deviation | hours in a month | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
|
|
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| Secondary | World Health Organization Quality of Life - Brief Version | World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a questionnaire with 24 items that correspond to four domains: physical health, psychological health, social relationships, and environment. Each question is rated on a five-point Likert scale. Each domain score is transformed based on the lowest possible score to create a modified range of 0-100 for each domain. All four domain scores are then averaged to create a single score on a range of 0-100, where higher values indicate higher quality of life. | 2 of the 25 participants did not have data at the second time point (post-intervention); 1 of the 25 participants did not have data at the third time point (one month post-intervention), and 1 of the participants did not have data at either the second or third time point. | Posted | Mean | Standard Deviation | score on a scale | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
|
|
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| Secondary | Brief Assessment of 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). Total score ranges from 0-50, where higher values indicate higher recovery capital. | 2 of the 25 participants did not have data at the second time point (post-intervention); 1 of the 25 participants did not have data at the third time point (one month post-intervention), and 1 of the participants did not have data at either the second or third time point. | Posted | Mean | Standard Deviation | score on a scale | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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