The Effectiveness of a Smartphone Application in the Treatment of Alcohol Use Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Other: U Control Drink Smartphone Application; Other: Control group

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, Dublin 8
    • Recruiting
    • St. Patrick's University Hospital
    • Contact: Conor Farren, PhD MRCPsych; Phone Number: +35312493523; Email: cfarren@stpatsmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients will fulfil the criteria for an alcohol use disorder according to the Structured Clinical Interview for DSM-5 Axis I Disorders
2. Patients must complete an alcohol treatment programme at St. Patrick's University Hospital.
3. Primary addiction must be alcohol in poly-substance abusers.
4. Aged over 18 years of age and capable of providing written, informed consent.
5. Mini Mental State Examination (MSSE) score of ≥25.
6. Patients must have an iphone or Android smartphone and are familiar with using smartphone applications.

Exclusion Criteria:

1. Patients whose primary substance of abuse is not alcohol, although may meet the criteria for alcohol dependency/abuse.
2. Patients who do not have an iPhone or Android smartphone.
3. Age <18years or >70years.
4. Psychotic disorder
5. Patients who do not fully complete an inpatient treatment programme before discharge.
6. History of alcohol use disorder but not current.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone Application Users; 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 smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification.
Active Comparator: Control Group; 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 control group will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
App activity score	Activity score on the app	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first drink	Number of days to first drink	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.	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.	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: St Patrick's Hospital, Ireland
• Investigators: Principal Investigator: Conor Farren, PhD,MRCPsych, St. Patrick's University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): July 31, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Alcohol Use Disorder; Smartphone Application
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Disease
• Other Study ID Numbers: UCD - Protocol 19/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No