Clinical trial NCT03396887: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol Use Disorder
Smartphone Application
Lead sponsor: St Patrick's Hospital, Ireland
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to intervention or control condition.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of drinking days
timeFrame: 3 months
measure: App activity score
timeFrame: 3 months
measure: Units of alcohol consumed per drinking day
timeFrame: 3 months
Secondary outcomes:
measure: Time to first drink
timeFrame: 3 months
measure: Changes in the Alcohol Use Disorders Identification Test scores from baseline
timeFrame: 3 months
measure: Changes in the Alcohol Abstinence Self-Efficacy Scale scores from baseline
timeFrame: 3 months
measure: Changes in the Obsessive Compulsive Drinking Scale scores from baseline
timeFrame: 3 months
measure: Changes in the Beck Depression Inventory scores from baseline
timeFrame: 3 months
measure: Changes in the Beck Anxiety Inventory scores from baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Patrick's University Hospital
Study officials:
affiliation: St. Patrick's University Hospital
name: Conor Farren, PhD,MRCPsych
role: PRINCIPAL_INVESTIGATOR
References: