An interventional study of U Control Drink Smartphone Application and Control group in Alcohol Use Disorder, sponsored by St Patrick's Hospital, Ireland. Status unknown at 1 site in Ireland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by St Patrick's Hospital, Ireland · Not applicable, Interventional, and Supportive care
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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 50 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →St Patrick's Hospital, Ireland is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: U Control Drink Smartphone Application
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.
Other: Control group
The smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification.
The control group will receive treatment as usual.
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.
Time frame: 3 months
App activity score
Activity score on the app
Time frame: 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.
Time frame: 3 months
Time to first drink
Number of days to first drink
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Jul 2018, 14 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 14 months is below that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St Patrick's Hospital, Ireland