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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AA029804 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This R01 project titled "Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19" is a Hybrid II RCT/implementation study to modify and test two of our alcohol smartphone interventions to address the fallout from COVID. We propose a three-arm RCT comparing a smartphone control group vs. a drinker-focused intervention vs. a family-focused intervention. All study arms recruit dyads comprising a person who drinks and a family partner.
The current randomized controlled trial tested whether PartnerCHESS (an ACHESS intervention along with aspects of Alcohol Behavioral Couple Therapy designed specifically for individuals with alcohol use disorder and their concerned significant other) could reduce high-risk drinking and improve quality of life.
For this trial, 199 dyads (398 participants) were recruited from the community and randomized 1:1:1 to the PartnerCHESS intervention, ACHESS intervention, or smartphone control for 8 months with a follow-up at 12 months. Participants were part of a dyad: identified patients met criteria for high-risk drinking (defined by the DSM-5) and had at least one drink in the past month, concerned significant others were the identified patient's romantic partner, family member, or close friend aged 21 or older. Primary outcomes were identified patient percent high-risk drinking days, and quality of life for both identified patients and concerned significant others. Participants were surveyed at baseline, 4, 8, and 12 months; PartnerCHESS and ACHESS usage data were continuously collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACHESS | Active Comparator | In ACHESS, both the identified patient and the concerned significant other will receive a smartphone, but only the identified patient will receive the ACHESS app. The concerned significant other will receive a smartphone with contact information for standard AUD, SUD, and crisis support. |
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| PartnerCHESS | Experimental | In the PartnerCHESS arm, identified patient and concerned significant other will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. |
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| Smartphone Control | No Intervention | Both the identified patient and concerned significant other will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PartnerCHESS | Behavioral | The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between identified patient and concerned significant other to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
| Measure | Description | Time Frame |
|---|---|---|
| % of Patient Risky Drinking Days | Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days. 8 months was the end of the intervention, 12 months was the final follow-up (4 months after the intervention ended). | 8 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Distress | The OQ45 measures the patient's and partner's outcomes during treatment by assessing three sub-domains, Symptom Distress, Interpersonal Relations, and Social Role. Scores from the Outcomes Questionnaire-45 range from 0-180, the higher the score, the higher the symptoms of distress. Cut-off score: 63 or more - indicates symptoms of clinical significance A high score suggests that the client is admitting to a large number of symptoms of distress (mainly anxiety, depression, somatic problems and stress) as well as difficulties in interpersonal relationships, social role (such as work or school), and in their general quality of life. Reliable change: indicated when a client's score changes by 14 points or more. |
| Measure | Description | Time Frame |
|---|---|---|
| % of Patient Risky Drinking Days | Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days. | Baseline, 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gustafson, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53706 | United States |
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No significant events occurred after enrollment and prior to assignment.
Recruitment was conducted from April 2022 to May 2023. The intervention period ended in June 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Smartphone Control - Identified Patient (IP) | Both the identified patient (IP) and concerned significant other (CSO) will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. |
| FG001 | ACHESS - Identified Patient (IP) | In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders |
| FG002 | PartnerCHESS - Identified Patient (IP) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
| FG003 | Smartphone Control - Concerned Significant Other (CSO) | Both the identified patient (IP) and concerned significant other (CSO) will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. |
| FG004 | ACHESS - Concerned Significant Other (CSO) | In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders |
| FG005 | PartnerCHESS - Concerned Significant Other (CSO) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smartphone Control - Identified Patient (IP) | Both the identified patient (IP) and concerned significant other (CSO) will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. |
| BG001 |
| 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 | % of Patient Risky Drinking Days | Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days. 8 months was the end of the intervention, 12 months was the final follow-up (4 months after the intervention ended). | Identified Patients in each arm (Smartphone Control, ACHESS, and PartnerCHESS) were surveyed at baseline, 4, 8, and 12 months. | Posted | Mean | Standard Error | percentage of high-risk drinking days | 8 and 12 months |
|
1 year
Adverse events in Redcap
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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 | Smartphone Control - Identified Patient (IP) | Both the identified patient (IP) and concerned significant other (CSO) will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kasey Thompson | CHESS - University of Wisconsin--Madison | 608-590-7821 | kfwagner@wisc.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 | Sep 7, 2023 | May 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Partner Version | Mar 30, 2022 | May 1, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Version | Mar 30, 2022 | May 1, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ACHESS | Behavioral | ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders |
|
| Baseline, 4, 8, and 12 months |
| % Days Abstinent | % days abstinent will be measured through the Timeline Followback every 120 days. | Baseline, 4, 8, and 12 months |
| Relationship Satisfaction | Determined by use of the Dyadic Adjustment Scale - 7 (DAS-7) which is a brief version of the 32 question Dyadic Adjustment Scale (DAS) and assesses the quality of marriage and similar dyads. Possible range is 0-36. Higher scores indicate more positive relationship quality. Scores less than 21 are considered to indicate a relationship in distress. | Baseline, 4, 8, and 12 months |
| Lost to Follow-up |
|
| ACHESS - Identified Patient (IP) |
In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders |
| BG002 | PartnerCHESS - Identified Patient (IP) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
| BG003 | Smartphone Control - Concerned Significant Other (CSO) | Both the identified patient (IP) and concerned significant other (CSO) will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. |
| BG004 | ACHESS - Concerned Significant Other (CSO) | In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders |
| BG005 | PartnerCHESS - Concerned Significant Other (CSO) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Man, Woman, or Other (nonbinary, prefer not to say, etc.) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Percentages do not sum to 100 because participants could endorse multiple times. | Count of Participants | Participants |
|
| Living arrangement | Percentages do not sum to 100 because participants could endorse multiple times. | Count of Participants | Participants |
|
| Dyad relationship type | Relationship type based on survey at baseline (some dyads had a discrepancy on how they defined their relationship, for example: romantic vs. friend). | Count of Participants | Participants |
|
| Employment status | Percentages do not sum to 100 because participants could endorse multiple times. | Count of Participants | Participants |
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| Vaccinated for COVID | Count of Participants | Participants |
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| Past month drug use or abuse | Percentages do not sum to 100 because participants could endorse multiple times. | Count of Participants | Participants |
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| Past month treatment | Percentages do not sum to 100 because participants could endorse multiple times. | Count of Participants | Participants |
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| Past month treatment engagement | Percentages do not sum to 100 because participants could endorse multiple times. | Count of Participants | Participants |
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| Other healthcare utilization | Percentages do not sum to 100 because participants could endorse multiple times. 12-step/self-help group could include Al-Anon. meetings. Emergency room visit reasons were not specified. | Count of Participants | Participants |
|
| Severe Alcohol Use Disorder | Based on DSM-5, Mild is defined as having 2-3 symptoms, Moderate is defined as having 4-5 symptoms, Severe is defined as having 6 or more symptoms (out of 11 total), only Identified Patients were screened for Alcohol Use Disorder eligibility. | Only Severe Alcohol Use was calculated, participants not shown had mild or moderate Alcohol Use Disorder as determined by the DSM-5. | Count of Participants | Participants |
|
| OG001 | ACHESS - Identified Patient (IP) | In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders |
| OG002 | PartnerCHESS - Identified Patient (IP) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
|
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| Secondary | Psychological Distress | The OQ45 measures the patient's and partner's outcomes during treatment by assessing three sub-domains, Symptom Distress, Interpersonal Relations, and Social Role. Scores from the Outcomes Questionnaire-45 range from 0-180, the higher the score, the higher the symptoms of distress. Cut-off score: 63 or more - indicates symptoms of clinical significance A high score suggests that the client is admitting to a large number of symptoms of distress (mainly anxiety, depression, somatic problems and stress) as well as difficulties in interpersonal relationships, social role (such as work or school), and in their general quality of life. Reliable change: indicated when a client's score changes by 14 points or more. | All participants (identified patients and concerned significant others from each arm) were surveyed at baseline, 4, 8, and 12 months. | Posted | Mean | Standard Deviation | score on a scale from 0-180 | Baseline, 4, 8, and 12 months |
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| Secondary | % Days Abstinent | % days abstinent will be measured through the Timeline Followback every 120 days. | Identified patients were surveyed at baseline, 4, 8, and 12 months. | Posted | Mean | Standard Deviation | percentage of days abstinent | Baseline, 4, 8, and 12 months |
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| Secondary | Relationship Satisfaction | Determined by use of the Dyadic Adjustment Scale - 7 (DAS-7) which is a brief version of the 32 question Dyadic Adjustment Scale (DAS) and assesses the quality of marriage and similar dyads. Possible range is 0-36. Higher scores indicate more positive relationship quality. Scores less than 21 are considered to indicate a relationship in distress. | Romantic dyads (identified patients and concerned significant others from each arm who stated their partner was a significant other/spouse at baseline) were surveyed at baseline, 4, 8, and 12 months. | Posted | Mean | Standard Deviation | score on a scale from 0-36 | Baseline, 4, 8, and 12 months |
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| Other Pre-specified | % of Patient Risky Drinking Days | Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days. | Identified Patients in each arm (Smartphone Control, ACHESS, and PartnerCHESS) were surveyed at baseline, 4, 8, and 12 months. | Posted | Mean | Standard Error | percentage of high-risk drinking days | Baseline, 4 months |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | ACHESS - Identified Patient (IP) | In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders | 1 | 66 | 0 | 66 | 0 | 66 |
| EG002 | PartnerCHESS - Identified Patient (IP) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG003 | Smartphone Control - Concerned Significant Other (CSO) | Both the identified patient (IP) and concerned significant other (CSO) will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. | 0 | 67 | 0 | 67 | 0 | 67 |
| EG004 | ACHESS - Concerned Significant Other (CSO) | In ACHESS, both the identified patient (IP) and the concerned significant other (CSO) will receive a smartphone, but only the IP will receive the ACHESS app. The CSO will receive a smartphone with contact information for standard AUD, SUD, and crisis support. ACHESS: ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders | 0 | 66 | 0 | 66 | 0 | 66 |
| EG005 | PartnerCHESS - Concerned Significant Other (CSO) | In the PartnerCHESS arm, identified patient (IP) and concerned significant other (CSO) will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services. PartnerCHESS: The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between IP and CSO to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. | 0 | 66 | 0 | 66 | 0 | 66 |
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| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Parent/adult child/other family member |
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| Friend |
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| No past month treatment |
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| Unknown |
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| 4 Months |
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| 8 Months |
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| 12 Months |
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| 8 Months |
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| 12 Months |
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| 4 Months |
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| 8 Months |
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| 12 Months |
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