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

Primary Purpose

Alcohol Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
U Control Drink Smartphone Application
Control group
Sponsored by
St Patrick's Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Use Disorder focused on measuring Alcohol Use Disorder, Smartphone Application

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Patrick's University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smartphone Application Users

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
App activity score
Activity score on the app
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.

Secondary Outcome Measures

Time to first drink
Number of days to first drink
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.
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.
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.
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.
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.

Full Information

First Posted
May 12, 2017
Last Updated
January 9, 2018
Sponsor
St Patrick's Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT03396887
Brief Title
The Effectiveness of a Smartphone Application in the Treatment of Alcohol Use Disorder
Official Title
The Effectiveness of a Smartphone Application in the Treatment of Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Patrick's Hospital, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol Use Disorder, Smartphone Application

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised to intervention or control condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone Application Users
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
U Control Drink Smartphone Application
Intervention Description
The smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will receive treatment as usual.
Primary Outcome Measure Information:
Title
Number of drinking days
Description
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
Title
App activity score
Description
Activity score on the app
Time Frame
3 months
Title
Units of alcohol consumed per drinking day
Description
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
Secondary Outcome Measure Information:
Title
Time to first drink
Description
Number of days to first drink
Time Frame
3 months
Title
Changes in the Alcohol Use Disorders Identification Test scores from baseline
Description
Changes in scores on the Alcohol Use Disorders Identification Test between baseline and 3 month follow-up assessment.
Time Frame
3 months
Title
Changes in the Alcohol Abstinence Self-Efficacy Scale scores from baseline
Description
Changes in the Alcohol Abstinence Self-Efficacy Scale scores between baseline and 3 month follow-up assessment.
Time Frame
3 months
Title
Changes in the Obsessive Compulsive Drinking Scale scores from baseline
Description
Changes in scores on the Obsessive Compulsive Drinking Scale between baseline and 3 month follow-up assessment.
Time Frame
3 months
Title
Changes in the Beck Depression Inventory scores from baseline
Description
Changes in scores on the Beck Depression Inventory between baseline and 3 month follow-up assessment.
Time Frame
3 months
Title
Changes in the Beck Anxiety Inventory scores from baseline
Description
Changes in scores on the Beck Anxiety Inventory between baseline and 3 month follow-up assessment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conor Farren, PhD,MRCPsych
Phone
+35312493523
Email
cfarren@stpatsmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conor Farren, PhD,MRCPsych
Organizational Affiliation
St. Patrick's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Patrick's University Hospital
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conor Farren, PhD MRCPsych
Phone
+35312493523
Email
cfarren@stpatsmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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