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| ID | Type | Description | Link |
|---|---|---|---|
| A195010 | Other Identifier | UW Madison | |
| ENGR/INDUSTRIAL ENGR | Other Identifier | UW Madison | |
| 1R34AA025675-01A1 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 7/6/2020 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| University of Massachusetts, Worcester | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims:
3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.
Alcohol use disorder (AUD) is one of the most common substance use disorders. Yet only a small fraction of people who need treatment receive it, and most of them get only short-term support even though continuing care has been shown to be much more effective. Partner support can be critical to recovery, but many partners do not know how to support their partners' recovery or manage their own responses to it. Clinicians also lack evidence of the efforts patients are making toward recovery. Treating couples in which one member is recovering from AUD has been shown to be efficacious; in particular, Alcohol Behavioral Couples Therapy (ABCT) has shown positive outcomes. Still, ABCT has not been widely adopted, in part because of practical problems such as the stigma that goes with the partner needing to go to an addiction treatment agency to participate. A-CHESS is a smartphone-based system proven to substantially reduce relapse rates, but A-CHESS serves only the patient.
This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims:
3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.
The project would engage 6 couples to help design PartnerCHESS, test its usability and give feedback on its utility. Once ready, the system would be tested by 34 other couples randomized to receive either PartnerCHESS + treatment as usual (TAU) or A-CHESS + TAU for a 6-month trial. The investigators will collect survey data at baseline, 2, 4, and 6 months and analyze it to see if a large clinical trial holds promise and, if so, produce an application to support a full-scale trial based on the technology developed and the research procedures employed in the pilot test.
The study is important to public health because of the scope of the alcohol abuse and the potential of technology to improve the lives of both patients and partners. If successful, such technology could greatly broaden the reach and impact of AUD treatment in general and couples therapy in particular.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-CHESS Drinker | Active Comparator | Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. |
|
| PartnerCHESS Drinker | Experimental | Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy. |
|
| A-CHESS Partner | Active Comparator | Patient's partner randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. |
|
| PartnerCHESS Partner | Experimental | Patient's partner randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PartnerCHESS | Behavioral | Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT: Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges. Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help. Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc. Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With no Heavy Drinking | At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. Risky drinking day was be defined as greater than 4 drinks for men and greater than 3 drinks for women in 2 hours. | baseline, 2, 4, and 6 months |
| Percentage of Days With Heavy Drinking | At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. | baseline, 2, 4, and 6 months |
| Percentage of Days With Any Drinking | At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. | Baseline, 2, 4, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Distress | Drinkers' and partners' psychological distress was assessed by the OQ-45 scale. Response options range from 0-4, with items 1, 12, 13, 20, 21, 24, 31, 37, and 43 reversed; items are summed (i.e., a possible range of 0-180). High scores suggest distress (anxiety, depression, somatic problems, stress), difficulties in interpersonal relationships and social roles (e.g., work), and low quality of life, with scores of 63 or more indicating symptoms of clinical significance, and changes of 14 points or more considered reliable. |
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A total of 34 dyads were recruited.
Patients and partners:
Patients:
Partners:
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| Name | Affiliation | Role |
|---|---|---|
| David H Gustafson, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley Street Treatment and Resources | Fall River | Massachusetts | 02720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39486022 | Derived | Gustafson DH Sr, Gustafson DH Jr, Mares ML, Johnston DC, Vjorn OJ, Curtin JJ, Epstein EE, Bailey GL. Couple-Focused Smartphone Intervention to Reduce Problem Drinking: Pilot Randomized Control Trial. JMIR Form Res. 2024 Nov 1;8:e58622. doi: 10.2196/58622. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-CHESS Dyads | Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. A-CHESS: A-CHESS control group |
| FG001 | PartnerCHESS Dyads | Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy. PartnerCHESS: Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT: Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges. Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help. Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc. Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | A-CHESS Drinker | Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. A-CHESS: A-CHESS control group |
| BG001 | PartnerCHESS Drinker | Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy. PartnerCHESS: Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT: Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges. Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help. Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc. Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With no Heavy Drinking | At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. Risky drinking day was be defined as greater than 4 drinks for men and greater than 3 drinks for women in 2 hours. | Posted | Count of Participants | Participants | baseline, 2, 4, and 6 months |
|
Up to 6 months
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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 | A-CHESS | Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. A-CHESS: A-CHESS control group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olivia Vjorn | UW Madison | 6084772614 | ocody@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 | Aug 20, 2020 | Sep 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| A-CHESS | Behavioral | A-CHESS control group |
|
| baseline, 2, 4, and 6 months |
| Relationship Satisfaction | Drinkers' and partners' relationship satisfaction was assessed by the Dyadic Adjustment Scale-Brief (DAS-7) plus item 32 from the DAS-32. Response options ranged 0-5 on most items and 0-6 on item 7 of the DAS-7 (possible scores range from 0 to 41). Consistent with scoring instructions for the DAS-7, items were summed, with higher scores indicating more satisfaction. | baseline, 2, 4, and 6 months |
| Perceptions of Family Environment - Cohesion | Drinkers and partners both completed the 9-item Cohesion and 9-item Conflict scales from the Family Environment Scale. Responses were true/false statements, with higher scores indicating more cohesion or conflict. Possible scores range from 4 to 65. | Baseline, 2, 4, 6 months |
| Perceptions of Family Environment - Conflict | Drinkers and partners both completed the 9-item Cohesion and 9-item Conflict scales from the Family Environment Scale. Responses were true/false statements, with higher scores indicating more cohesion or conflict. Possible scores range from 33 to 80. | Baseline, 2, 4, 6 months |
| Commitment to Sobriety | Drinkers completed the 5-item Commitment to Sobriety Scale. Response options ranged 1-5 for a total possible range of scores from 5-25; with higher scores suggesting more commitment. | Baseline, 2, 4, 6 months |
| Peer Support | Partners reported on the availability of peer support using the 5-item McTavish Bonding Scale. Response options ranged 1-5 for a total possible range of scores from 5-25; with higher scores suggesting more support. | Baseline, 2, 4, 6 months |
| BG002 | A-CHESS Partner | Participants randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. A-CHESS: A-CHESS control group |
| BG003 | PartnerCHESS Partner | Participants randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy. PartnerCHESS: Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT: Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges. Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help. Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc. Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Living with partner | Count of Participants | Participants |
|
| Alcohol use disorder severity (DSM-5) | This was not measured for partners, because they are not being assessed for Alcohol use disorder. | The number analyzed differs from overall number because partners were not being assessed for Alcohol use disorder. | Count of Participants | Participants |
|
|
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| Primary | Percentage of Days With Heavy Drinking | At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. | Posted | Mean | Standard Deviation | percentage of days | baseline, 2, 4, and 6 months |
|
|
|
| Primary | Percentage of Days With Any Drinking | At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. | Posted | Mean | Standard Deviation | percentage of days | Baseline, 2, 4, 6 months |
|
|
|
| Secondary | Psychological Distress | Drinkers' and partners' psychological distress was assessed by the OQ-45 scale. Response options range from 0-4, with items 1, 12, 13, 20, 21, 24, 31, 37, and 43 reversed; items are summed (i.e., a possible range of 0-180). High scores suggest distress (anxiety, depression, somatic problems, stress), difficulties in interpersonal relationships and social roles (e.g., work), and low quality of life, with scores of 63 or more indicating symptoms of clinical significance, and changes of 14 points or more considered reliable. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2, 4, and 6 months |
|
|
|
| Secondary | Relationship Satisfaction | Drinkers' and partners' relationship satisfaction was assessed by the Dyadic Adjustment Scale-Brief (DAS-7) plus item 32 from the DAS-32. Response options ranged 0-5 on most items and 0-6 on item 7 of the DAS-7 (possible scores range from 0 to 41). Consistent with scoring instructions for the DAS-7, items were summed, with higher scores indicating more satisfaction. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2, 4, and 6 months |
|
|
|
| Secondary | Perceptions of Family Environment - Cohesion | Drinkers and partners both completed the 9-item Cohesion and 9-item Conflict scales from the Family Environment Scale. Responses were true/false statements, with higher scores indicating more cohesion or conflict. Possible scores range from 4 to 65. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6 months |
|
|
|
| Secondary | Perceptions of Family Environment - Conflict | Drinkers and partners both completed the 9-item Cohesion and 9-item Conflict scales from the Family Environment Scale. Responses were true/false statements, with higher scores indicating more cohesion or conflict. Possible scores range from 33 to 80. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6 months |
|
|
|
| Secondary | Commitment to Sobriety | Drinkers completed the 5-item Commitment to Sobriety Scale. Response options ranged 1-5 for a total possible range of scores from 5-25; with higher scores suggesting more commitment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6 months |
|
|
|
| Secondary | Peer Support | Partners reported on the availability of peer support using the 5-item McTavish Bonding Scale. Response options ranged 1-5 for a total possible range of scores from 5-25; with higher scores suggesting more support. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6 months |
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|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | PartnerCHESS | Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy. PartnerCHESS: Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT: Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges. Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help. Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc. Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Moderate 4-5 |
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| Severe 6+ |
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| 4 months |
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| 6 months |
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| 4 months |
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| 6 months |
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| 2 months |
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| 4 months |
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| 6 months |
|
| 2 months |
|
| 4 months |
|
| 6 months |
|
| 2 months |
|
| 4 months |
|
| 6 months |
|
| 2 months |
|
| 4 months |
|
| 6 months |
|
| 4 months |
|
| 6 months |
|
| 4 months |
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| 6 months |
|