Alcohol Use DisorderNCT03396887
The Effectiveness of a Smartphone Application in the Treatment of Alcohol Use Disorder
A study of Alcohol Use Disorder, run by St Patrick's Hospital, Ireland at 1 site in Ireland.
Trial summary
Alcohol dependence poses a major problem for Irish and UK society, placing a huge burden on the health system. It is difficult to treat and relapse is common. There is an urgent need to develop novel treatment methods. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 1 May 2017to 30 Sep 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will fulfil the criteria for an alcohol use disorder according to the Structured Clinical Interview for DSM-5 Axis I Disorders
- Patients must complete an alcohol treatment programme at St. Patrick's University Hospital.
- Primary addiction must be alcohol in poly-substance abusers.
- Aged over 18 years of age and capable of providing written, informed consent.
- Mini Mental State Examination (MSSE) score of ≥25.
- Patients must have an iphone or Android smartphone and are familiar with using smartphone applications.
Who cannot join
- Patients whose primary substance of abuse is not alcohol, although may meet the criteria for alcohol dependency/abuse.
- Patients who do not have an iPhone or Android smartphone.
- Age <18years or >70years.
- Psychotic disorder
- Patients who do not fully complete an inpatient treatment programme before discharge.
- History of alcohol use disorder but not current.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St. Patrick's University Hospital
Dublin, Dublin 8
Conor Farren, PhD MRCPsych, +35312493523, cfarren@stpatsmail.com
About this study
Alcohol dependence poses a major problem for Irish and UK society, placing a huge burden on the health system. It is difficult to treat and relapse is common. There is an urgent need to develop novel treatment methods. One growing area of intervention is the use of mobile phone technology to develop personalised, patient-centred treatments. These can be used in outpatient settings, allowing patients to manage their own illness and take control of their recovery. In this study the investigators will investigate how a smartphone application, UControlDrink, can help alcoholics stay abstinent from alcohol. The application consists of a number of features known to aid recovery such as supportive messages and online therapy.
Read the detailed description
Alcohol use disorder (AUD) is a common and difficult disorder to treat. Only a fraction of sufferers seek treatment and the rate of relapse is high. There is therefore an urgent need for improved methods of promoting long term abstinence and recovery in AUD. This study will explore the effectiveness of a smartphone application, UControlDrink, in aiding recovery from AUD in patients who have been discharged from an inpatient alcohol treatment programme. The application comprises five recovery focused features:
supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, activities and trigger avoidance log, craving management and gamification. Patients will use the application for 3 months. A control group of patients will also be followed over the same time period. Cumulative abstinence duration as well as changes in questionnaire measures to baseline, time to first drink, proportion of patients continuously abstinent from alcohol, levels of activity within the app and patient satisfaction with their overall treatment will be measured at 3 months. If successful, this application may offer a unique, patient-centred, technology-driven, cost effective method of improving outcomes in AUD.
- Conditions
- Alcohol Use Disorder
- Being tested
- U Control Drink Smartphone Application, Control group
- Keywords
- Alcohol Use Disorder, Smartphone Application
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U Control Drink Smartphone ApplicationOther
The smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification.
Control groupOther
The control group will receive treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application Users | Experimental | The experimental group will receive the smartphone intervention along with treatment as usual for 3-months. The smartphone application (UControlDrink) includes twice daily text message recovery support, relapse prevention cognitive behavioural therapy, 12 sessions in total, drinking and recovery activity logs where participants detail their abstinence, drinking and recovery activity engagement on a daily basis. Craving intervention in the form of a "calm button" to deal with cravings and prevent relapse and gamification, a system of encouraging positive behaviour with the awarding of "points" to achieve various "status" levels, is used to increase adherence and compliance with treatment recommendations. Receives: Other: U Control Drink Smartphone Application |
| Control Group | Active comparator | The control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinking days
The number of drinking days will be assessed using the Time Line to Follow-Back scale (TLFB).The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record the number of days they drank over the previous 90 days. Drinking days will be calculated by summing the total number of days when alcohol was consumed in the previous 90 days.
Measured: 3 months
App activity score
Activity score on the app
Measured: 3 months
Units of alcohol consumed per drinking day
The Time Line Follow Back (TLFB) will be used to record the average number of units of alcohol consumed on drinking days.
Measured: 3 months
Secondary outcomes (6)
Time to first drink
Number of days to first drink
Measured: 3 months
Changes in the Alcohol Use Disorders Identification Test scores from baseline
Changes in scores on the Alcohol Use Disorders Identification Test between baseline and 3 month follow-up assessment.
Measured: 3 months
Changes in the Alcohol Abstinence Self-Efficacy Scale scores from baseline
Changes in the Alcohol Abstinence Self-Efficacy Scale scores between baseline and 3 month follow-up assessment.
Measured: 3 months
Changes in the Obsessive Compulsive Drinking Scale scores from baseline
Changes in scores on the Obsessive Compulsive Drinking Scale between baseline and 3 month follow-up assessment.
Measured: 3 months
Changes in the Beck Depression Inventory scores from baseline
Changes in scores on the Beck Depression Inventory between baseline and 3 month follow-up assessment.
Measured: 3 months
Changes in the Beck Anxiety Inventory scores from baseline
Changes in scores on the Beck Anxiety Inventory between baseline and 3 month follow-up assessment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start1 May 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to intervention or control condition.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Patrick's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Conor Farren, St Patrick's Hospital, Ireland
- Investigators
- Conor Farren, PhD,MRCPsych, Principal investigator, St. Patrick's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396887
- Sponsor's protocol ID
- UCD - Protocol 19/15
- Status last verified
- Nov 2017
- First submitted
- 12 May 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Smartphone Application in the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03396887
- Acronym / sponsor ID
- UCD - Protocol 19/15
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol Use Disorder, Smartphone Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St Patrick's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 11 Jan 2018 (actual)
- 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.
Alcohol dependence poses a major problem for Irish and UK society, placing a huge burden on the health system. It is difficult to treat and relapse is common. There is an urgent need to develop novel treatment methods. One growing area of intervention is the use of mobile phone technology to develop personalised, patient-centred treatments. These can be used in outpatient settings, allowing patients to manage their own illness and take control of their recovery. In this study the investigators will investigate how a smartphone application, UControlDrink, can help alcoholics stay abstinent from alcohol. The application consists of a number of features known to aid recovery such as supportive messages and online therapy.
Detailed description
Alcohol use disorder (AUD) is a common and difficult disorder to treat. Only a fraction of sufferers seek treatment and the rate of relapse is high. There is therefore an urgent need for improved methods of promoting long term abstinence and recovery in AUD. This study will explore the effectiveness of a smartphone application, UControlDrink, in aiding recovery from AUD in patients who have been discharged from an inpatient alcohol treatment programme. The application comprises five recovery focused features:
supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, activities and trigger avoidance log, craving management and gamification. Patients will use the application for 3 months. A control group of patients will also be followed over the same time period. Cumulative abstinence duration as well as changes in questionnaire measures to baseline, time to first drink, proportion of patients continuously abstinent from alcohol, levels of activity within the app and patient satisfaction with their overall treatment will be measured at 3 months. If successful, this application may offer a unique, patient-centred, technology-driven, cost effective method of improving outcomes in AUD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomised to intervention or control condition.
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application Users | Experimental | Other: U Control Drink Smartphone ApplicationThe experimental group will receive the smartphone intervention along with treatment as usual for 3-months. The smartphone application (UControlDrink) includes twice daily text message recovery support, relapse prevention cognitive behavioural therapy, 12 sessions in total, drinking and recovery activity logs where participants detail their abstinence, drinking and recovery activity engagement on a daily basis. Craving intervention in the form of a "calm button" to deal with cravings and prevent relapse and gamification, a system of encouraging positive behaviour with the awarding of "points" to achieve various "status" levels, is used to increase adherence and compliance with treatment recommendations. |
| Control Group | Active comparator | Other: Control groupThe control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will fulfil the criteria for an alcohol use disorder according to the Structured Clinical Interview for DSM-5 Axis I Disorders
- Patients must complete an alcohol treatment programme at St. Patrick's University Hospital.
- Primary addiction must be alcohol in poly-substance abusers.
- Aged over 18 years of age and capable of providing written, informed consent.
- Mini Mental State Examination (MSSE) score of ≥25.
Key exclusion criteria (6 listed)
- Patients whose primary substance of abuse is not alcohol, although may meet the criteria for alcohol dependency/abuse.
- Patients who do not have an iPhone or Android smartphone.
- Age <18years or >70years.
- Psychotic disorder
- Patients who do not fully complete an inpatient treatment programme before discharge.
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 |
|---|---|---|
| U Control Drink Smartphone ApplicationThe smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification. | Other | Smartphone Application Users |
| Control groupThe control group will receive treatment as usual. | Other | Control Group |
Primary outcome
Number of drinking days
Time frame: 3 months
The number of drinking days will be assessed using the Time Line to Follow-Back scale (TLFB).The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record the number of days they drank over the previous 90 days. Drinking days will be calculated by summing the total number of days when alcohol was consumed in the previous 90 days.
App activity score
Time frame: 3 months
Activity score on the app
Units of alcohol consumed per drinking day
Time frame: 3 months
The Time Line Follow Back (TLFB) will be used to record the average number of units of alcohol consumed on drinking days.
6 secondary outcomes
Time to first drink
Time frame: 3 months
Changes in the Alcohol Use Disorders Identification Test scores from baseline
Time frame: 3 months
Changes in the Alcohol Abstinence Self-Efficacy Scale scores from baseline
Time frame: 3 months
Changes in the Obsessive Compulsive Drinking Scale scores from baseline
Time frame: 3 months
Changes in the Beck Depression Inventory scores from baseline
Time frame: 3 months
Changes in the Beck Anxiety Inventory scores from baseline
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Conor Farren, PhD,MRCPsych principal investigator
St. Patrick's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Alcohol Use Disorder, run by St Patrick's Hospital, Ireland at 1 site in Ireland.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conor Farren, PhD,MRCPsych (+35312493523, cfarren@stpatsmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of drinking days (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2018.