Alcohol DependenceNCT01003119
Computer-Based Alcohol Use Disorder Recovery System
A study testing Addiction CHESS in people with Alcohol Dependence, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The purpose of this grant is to develop and test a proven computer based quality improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support System) to help prevent relapse in alcohol dependent patients being discharged from residential treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Addiction CHESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must be at least 18 years of age
- All subjects must be willing to participate in the study
- All subjects must be willing to identify two people who could provide contact information about their location for the next year
- If randomized into ACHESS, all subjects must agree to allow monitoring of their ACHESS usage, including internet browsing
- All subjects must pass a literacy test
Who cannot join
- Homelessness
- Psychiatric or medical condition that precludes participation in the study including: subjects with a history of suicidality, significant developmental/cognitive impairments that limit their ability to understand the material or have vision problems will not be included in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CAB Health and Recovery Services
Boston, Massachusetts, 01960
Fayette Companies
Peoria, Illinois, 61654
About this study
Official title: Developing and Testing a Computer-Based Alcohol Use Disorder Recovery System
The purpose of this grant is to develop and test a proven computer based quality improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support System) to help prevent relapse in alcohol dependent patients being discharged from residential treatment. The investigators' primary hypothesis is that ACHESS (Addiction CHESS) will improve competence, relatedness and autonomy, which will reduce the days of risky drinking over a 12-month period.
Read the detailed description
The system to be tested (ACHESS - Addiction CHESS) will be delivered through a new modality (smart-phone rather than PC) to make access more widespread, focus on new patients (alcohol dependent patients leaving residential care), offer optional audio delivery to improve access for those who have literacy challenges and be enhanced with services tailored to relapse prevention. ACHESS will offer: 1) communication with peer support groups and addiction experts; 2) timely monitoring to assess risk of relapse, 3) reminders and alerts to encourage adherence to therapeutic goals; 4) addiction-related educational material and tools tailored to the needs of the particular patient, 5) access to selected Internet based resources and 6) communication with a care manager. Patients randomly assigned to ACHESS will learn to use it prior to discharge from residential care.
- Conditions
- Alcohol Dependence
- Being tested
- Addiction CHESS
- Keywords
- Alcohol addiction, Alcohol treatment, Alcohol recovery, Post residential treatment DSM-IV diagnosis of alcohol dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addiction CHESSBehavioural
Smartphone with ACHESS application loaded onto the phone.
| Study group | Role | What they receive |
|---|---|---|
| A CHESS | Experimental | Those in the ACHESS arm will also be given a smart-phone with access to the ACHESS system (the intervention) for a full 12 months. The ACHESS intervention includes: 1) the Core CHESS system that has been tested in several diseases, 2) a proactive computer-based relapse prevention system, 3) data transfer from the phone to a computer accessible by the patient's counselor/care manager, and 4) systems for the patient to maintain contact with his/her Care Manager Receives: Behavioral: Addiction CHESS |
| Usual Care | No intervention | Those randomized into the Usual Care group will receive usual medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACHESS + standard care will reduce days of risky drinking over the 12-month follow-up period as measured by three interviews. The time-line follow-back techniques will be used'.
Measured: 12 months
Secondary outcomes (1)
ACHESS will reduce proximal outcomes of cravings and negative affect, and produce distal outcomes of increased complete abstinence from alcohol, days of abstinence and reduced negative consequences of substance use.
Measured: 12 mos.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David H Gustafson, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003119
- Sponsor's protocol ID
- SE-2009-0484
- Other IDs
- R01AA017192
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2009
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gustafson DH, Shaw BR, Isham A, Baker T, Boyle MG, Levy M. Explicating an evidence-based, theoretically informed, mobile technology-based system to improve outcomes for people in recovery for alcohol dependence. Subst Use Misuse. 2011;46(1):96-111. doi: 10.3109/10826084.2011.521413.
PubMed 21190410McTavish FM, Chih MY, Shah D, Gustafson DH. How Patients Recovering From Alcoholism Use a Smartphone Intervention. J Dual Diagn. 2012;8(4):294-304. doi: 10.1080/15504263.2012.723312. Epub 2012 Nov 8.
PubMed 23316127Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.
PubMed 24671165
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Computer-Based Alcohol Use Disorder Recovery System
- ClinicalTrials.gov ID
- NCT01003119
- Acronym / sponsor ID
- SE-2009-0484
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol addiction, Alcohol treatment, Alcohol recovery, Post residential treatment DSM-IV diagnosis of alcohol dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this grant is to develop and test a proven computer based quality improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support System) to help prevent relapse in alcohol dependent patients being discharged from residential treatment. The investigators' primary hypothesis is that ACHESS (Addiction CHESS) will improve competence, relatedness and autonomy, which will reduce the days of risky drinking over a 12-month period.
Detailed description
The system to be tested (ACHESS - Addiction CHESS) will be delivered through a new modality (smart-phone rather than PC) to make access more widespread, focus on new patients (alcohol dependent patients leaving residential care), offer optional audio delivery to improve access for those who have literacy challenges and be enhanced with services tailored to relapse prevention. ACHESS will offer: 1) communication with peer support groups and addiction experts; 2) timely monitoring to assess risk of relapse, 3) reminders and alerts to encourage adherence to therapeutic goals; 4) addiction-related educational material and tools tailored to the needs of the particular patient, 5) access to selected Internet based resources and 6) communication with a care manager. Patients randomly assigned to ACHESS will learn to use it prior to discharge from residential care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A CHESS | Experimental | Behavioral: Addiction CHESSThose in the ACHESS arm will also be given a smart-phone with access to the ACHESS system (the intervention) for a full 12 months. The ACHESS intervention includes: 1) the Core CHESS system that has been tested in several diseases, 2) a proactive computer-based relapse prevention system, 3) data transfer from the phone to a computer accessible by the patient's counselor/care manager, and 4) systems for the patient to maintain contact with his/her Care Manager |
| Usual Care | No intervention | –Those randomized into the Usual Care group will receive usual medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects must be at least 18 years of age
- All subjects must be willing to participate in the study
- All subjects must be willing to identify two people who could provide contact information about their location for the next year
- If randomized into ACHESS, all subjects must agree to allow monitoring of their ACHESS usage, including internet browsing
- All subjects must pass a literacy test
Key exclusion criteria (2 listed)
- Homelessness
- Psychiatric or medical condition that precludes participation in the study including: subjects with a history of suicidality, significant developmental/cognitive impairments that limit their ability to understand the material or have vision problems will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addiction CHESSSmartphone with ACHESS application loaded onto the phone. | Behavioural | A CHESS |
Primary outcome
ACHESS + standard care will reduce days of risky drinking over the 12-month follow-up period as measured by three interviews. The time-line follow-back techniques will be used'.
Time frame: 12 months
1 secondary outcome
ACHESS will reduce proximal outcomes of cravings and negative affect, and produce distal outcomes of increased complete abstinence from alcohol, days of abstinence and reduced negative consequences of substance use.
Time frame: 12 mos.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Background: PubMed 21190410Gustafson DH, Shaw BR, Isham A, Baker T, Boyle MG, Levy M. Explicating an evidence-based, theoretically informed, mobile technology-based system to improve outcomes for people in recovery for alcohol dependence. Subst Use Misuse. 2011;46(1):96-111. doi: 10.3109/10826084.2011.521413.
- Results publication: PubMed 23316127McTavish FM, Chih MY, Shah D, Gustafson DH. How Patients Recovering From Alcoholism Use a Smartphone Intervention. J Dual Diagn. 2012;8(4):294-304. doi: 10.1080/15504263.2012.723312. Epub 2012 Nov 8.
- Results publication: PubMed 24671165Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.
- Project DescriptionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Gustafson, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addiction CHESS in people with Alcohol Dependence, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACHESS + standard care will reduce days of risky drinking over the 12-month follow-up period as measured by three interviews. The time-line follow-back techniques will be used'. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003119, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016; AzTrials last refreshed its copy on 29 Oct 2026.