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Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder, Couples, Behavior, Addictive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PartnerCHESS
A-CHESS
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

A total of 40 dyads will be recruited.

Patients and partners:

  • Must be 18 or older
  • Not have a mental or physical condition that limits smartphone use
  • Cannot have experienced serious Interpersonal ViolenceIntimate Partner Violence (IPV) in the index (therapy) relationship in the past year
  • Not have a history of schizophrenia

Patients:

  • Must have a DSM-5 diagnosis of alcohol use disorder or meet NIAAA guidelines for risky drinking.
  • Have had at least one alcoholic drink in the last 6 months

Partners:

  • Must be a spouse, or in a 6-month or longer committed romantic relationship
  • Willing to participate in the study

Sites / Locations

  • Stanley Street Treatment and Resources

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A-CHESS Drinker

PartnerCHESS Drinker

A-CHESS Partner

PartnerCHESS Partner

Arm Description

Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.

Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy.

Patient's partner randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.

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.

Outcomes

Primary Outcome Measures

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.
Percentage of Days With Heavy Drinking
At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.
Percentage of Days With Any Drinking
At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 14, 2019
Last Updated
November 15, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
University of Massachusetts, Worcester, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04059549
Brief Title
Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
Official Title
Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
University of Massachusetts, Worcester, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT. 3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.
Detailed Description
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: Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Couples, Behavior, Addictive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-CHESS Drinker
Arm Type
Active Comparator
Arm Description
Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.
Arm Title
PartnerCHESS Drinker
Arm Type
Experimental
Arm Description
Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy.
Arm Title
A-CHESS Partner
Arm Type
Active Comparator
Arm Description
Patient's partner randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.
Arm Title
PartnerCHESS Partner
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PartnerCHESS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
A-CHESS
Intervention Description
A-CHESS control group
Primary Outcome Measure Information:
Title
Number of Participants With no Heavy Drinking
Description
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.
Time Frame
baseline, 2, 4, and 6 months
Title
Percentage of Days With Heavy Drinking
Description
At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.
Time Frame
baseline, 2, 4, and 6 months
Title
Percentage of Days With Any Drinking
Description
At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.
Time Frame
Baseline, 2, 4, 6 months
Secondary Outcome Measure Information:
Title
Psychological Distress
Description
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.
Time Frame
baseline, 2, 4, and 6 months
Title
Relationship Satisfaction
Description
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.
Time Frame
baseline, 2, 4, and 6 months
Title
Perceptions of Family Environment - Cohesion
Description
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.
Time Frame
Baseline, 2, 4, 6 months
Title
Perceptions of Family Environment - Conflict
Description
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.
Time Frame
Baseline, 2, 4, 6 months
Title
Commitment to Sobriety
Description
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.
Time Frame
Baseline, 2, 4, 6 months
Title
Peer Support
Description
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.
Time Frame
Baseline, 2, 4, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
A total of 34 dyads were recruited. Patients and partners: Must be 18 or older Not have a mental or physical condition that limits smartphone use Cannot have experienced serious Interpersonal Violence Intimate Partner Violence (IPV) in the index (therapy) relationship in the past year Not have a history of schizophrenia Patients: Must have a DSM-5 diagnosis of alcohol use disorder or meet NIAAA guidelines for risky drinking. Have had at least one alcoholic drink in the last 6 months Partners: Must be a spouse, or in a 6-month or longer committed romantic relationship Willing to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Gustafson, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanley Street Treatment and Resources
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder

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