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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03396887
• Other study ID #: UCD - Protocol 19/15
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2017
• Last updated: January 9, 2018
• Start date: May 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2017
• Source: St Patrick's Hospital, Ireland
• Contact: Conor Farren, PhD,MRCPsych
• Phone: +35312493523
• Email: cfarren[@]stpatsmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Disease

Intervention

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.
• Control group
The control group will receive treatment as usual.

Locations

Country	Name	City	State
Ireland	St. Patrick's University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St Patrick's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	App activity score	Activity score on the app	3 months
Primary	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	Time to first drink	Number of days to first drink	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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