NCT03396887

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 11, 2018

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

May 12, 2017

Last Update Submit

January 9, 2018

Conditions

Keywords

Alcohol Use DisorderSmartphone Application

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Time to first drink

    3 months

  • Changes in the Alcohol Use Disorders Identification Test scores from baseline

    3 months

  • Changes in the Alcohol Abstinence Self-Efficacy Scale scores from baseline

    3 months

  • Changes in the Obsessive Compulsive Drinking Scale scores from baseline

    3 months

  • Changes in the Beck Depression Inventory scores from baseline

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Smartphone Application Users

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

The smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification.

Smartphone Application Users

The control group will receive treatment as usual.

Control Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Patrick's University Hospital

Dublin, Dublin 8, Ireland

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Conor Farren, PhD,MRCPsych

    St. Patrick's University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Conor Farren, PhD,MRCPsych

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomised to intervention or control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Psychiatrist

Study Record Dates

First Submitted

May 12, 2017

First Posted

January 11, 2018

Study Start

May 1, 2017

Primary Completion

July 31, 2018

Study Completion

September 30, 2018

Last Updated

January 11, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations