Alcohol, Alcohol; Harmful Use
Conditions
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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Drinking Days Per Month | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) | 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. |
| Brief Assessment of Recovery Capital | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) | 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. |
| Percentage of Heavy Drinking Days Per Month | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) | 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. |
| Hours Spent Engaging With Recovery Support Services | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) | 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. |
| World Health Organization Quality of Life - Brief Version | Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete baseline questionnaire / did not begin using intervention | 4 |
| Overall Study | Dropped out of study for higher level of care | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | LDART |
|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Past-year AUDIT score | 22.7 units on a scale STANDARD_DEVIATION 8.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Intervention Acceptability (Engagement With Intervention)
Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.
Time frame: Duration of intervention (Days 1-28)
Population: The one participants who dropped out mid-intervention for higher level of care was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDART | Intervention Acceptability (Engagement With Intervention) | 22.9 nights | Standard Deviation 4.3 |
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.
Time frame: Post-intervention (Day 28)
Population: Of the 25 participants who completed the intervention, 3 did not complete the acceptability ratings, and 1 participant skipped this question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LDART | Intervention Acceptability (Subjective Experience) | 18 Participants |
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.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDART | Recruitment Feasibility | 10 participants per month |
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.
Time frame: One-month post-intervention (Day 56)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LDART | Retention Feasibility | 23 Participants |
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.
Time frame: Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDART | Brief Assessment of Recovery Capital | Pre-intervention | 43.9 score on a scale | Standard Deviation 8 |
| LDART | Brief Assessment of Recovery Capital | Post intervention | 46.9 score on a scale | Standard Deviation 9.2 |
| LDART | Brief Assessment of Recovery Capital | 1-month post-intervention | 45.3 score on a scale | Standard Deviation 7.9 |
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.
Time frame: Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention)
Population: 2 of the 25 participants did not have data at the third time point (one month post-intervention) so were excluded from analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDART | Hours Spent Engaging With Recovery Support Services | During intervention | 10.8 hours in a month | Standard Deviation 25.4 |
| LDART | Hours Spent Engaging With Recovery Support Services | Pre-intervention | 2.4 hours in a month | Standard Deviation 5.5 |
| LDART | Hours Spent Engaging With Recovery Support Services | Post-intervention | 7.6 hours in a month | Standard Deviation 12.7 |
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.
Time frame: Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention)
Population: 2 of the 25 participants did not have data at the third time point (one month post-intervention) so were excluded from analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDART | Percentage of Drinking Days Per Month | Pre-intervention | 61.3 Percentage of days in a month | Standard Deviation 31.2 |
| LDART | Percentage of Drinking Days Per Month | During intervention | 45.2 Percentage of days in a month | Standard Deviation 34.6 |
| LDART | Percentage of Drinking Days Per Month | Post-intervention | 42.6 Percentage of days in a month | Standard Deviation 34.2 |
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.
Time frame: Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention)
Population: 2 of the 25 participants did not have data at the third time point (one month post-intervention) so were excluded from analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDART | Percentage of Heavy Drinking Days Per Month | Pre-intervention | 27.1 Percentage of days in a month | Standard Deviation 30 |
| LDART | Percentage of Heavy Drinking Days Per Month | During intervention | 17.1 Percentage of days in a month | Standard Deviation 22.5 |
| LDART | Percentage of Heavy Drinking Days Per Month | Post-intervention | 17.9 Percentage of days in a month | Standard Deviation 23.2 |
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.
Time frame: Day 0 (Pre-intervention), 28 (Post-intervention), and 56 (1-month post-intervention)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDART | World Health Organization Quality of Life - Brief Version | Pre-intervention | 57.1 score on a scale | Standard Deviation 4.3 |
| LDART | World Health Organization Quality of Life - Brief Version | Post-intervention | 60.7 score on a scale | Standard Deviation 4.4 |
| LDART | World Health Organization Quality of Life - Brief Version | 1-month post-intervention | 60.1 score on a scale | Standard Deviation 4.7 |