ISRCTN - ISRCTN35240647: SMS study for alcohol consumption reduction

Plain English Summary

Background and study aims
Alcohol dependence is a common disease with high rates of recovery but also high morbidity and mortality in chronic courses. Recurrent alcohol consumption occurs frequently after inpatient detoxification, and also many alcohol dependent patients do not respond well to further treatment. Inpatient treatments aiming at staying away from alcohol after discharge do not take into account that alcohol use disorders are chronic diseases and should be treated continuously. Counselling services may lose track of their patients. Feelings of guilt and shame and physical inability also are barriers to treatment. Outreach services (home visits) are costly and therefore not common. One solution could be a mobile phone based system to maintain contact.

Who can participate?
Patients (age >=18 y) with alcohol dependence after inpatient alcohol detoxification in the
psychiatric hospital in Stralsund, who can receive and send SMS and are able to answer questionnaires.

What does the study involve?
Patients were randomly assigned to one of two groups. In the SMS-group, patients received automatically generated personalized mobile phone SMS twice a week for eight weeks. Patients were requested to answer within 24h with "B" (no help is needed) or "A" (help is needed or relapse has occurred). They also could send an "emergency SMS" anytime. In case of help-need, an e-mail was sent to a therapist who will call the patient by telephone. The therapist would then provide brief telephone counselling and may recommend existing treatments (support, brief interventions, outpatient treatment or readmission). Patients sending "B" received an automatically generated supportive SMS. Outcome parameters were assessed via telephone after 4 and 8 weeks. Group 2 is the control group and does not receive SMS but treatment as usual.

What are the possible benefits and risks of participating?
Patients in the SMS-group are in close contact with their therapists with a possible positive effect on alcohol consumption. There are no risks for either the SMS or the control group.

Where is the study run from?
Hospital for Psychiatry and Psychotherapy at HELIOS Hanseklinikum, University of Greifswald, Stralsund; Michael Lucht, MD

When is the study starting and how long is it expected to run for?
The study has already been conducted (Start: May 2009, End: May 2010)
Approximate duration of the trial: 12 months

Who is funding the study?
Hospital for Psychiatry and Psychotherapy, Greifswald University Medicine, HELIOS Hanseklinikum Stralsund, Germany.

Who is the main contact?
Michael Lucht, MD
lucht@uni-greifswald.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Lucht

ORCID ID

Contact details

Hospital for Psychiatry and Psychotherapy
University Medicine Greifswald at HELIOS Hanseklinikum Stralsund
Rostocker Chaussee 70
Haus 30
Stralsund
18437
Germany
+49 38381 452143
lucht@uni-greifswald.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An intervention using mobile phone short message service to reduce alcohol consumption among alcohol dependent patients

Acronym

Study hypothesis

Evaluate the efficacy of a 2-month standardized outpatient interactive mobile phone SMS intervention to increase low-risk alcohol consumption rates (males: <= 30 g alcohol/typical drinking day; females: females: <= 20 g alcohol/typical drinking day) in alcohol dependent patients after inpatient detoxification.

Note:
We started with the SMS-system as clinical add-on to treatment as usual, to find out, if the system works (pilot-study). All patient signed an informed consent for participation and data use. There was no randomisation at this stage. We then decided to proceed with a control group and applied for approval of the Ethics Committee. The first patient of the control group was included on November 11th, 2009 (after approval of the Ethics committee).

Ethics approval

Ethics Committee of the University of Greifswald (Ethikkommission der Ernst-Moritz-Arndt Universitaet Greifswald) Friedrich-Loeffler-Str, 17489 Greifswald, October 1st, 2009, Ref.-Nr. BB71/09

Study design

Randomised controlled two-armed single-centre time frame randomisation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet in German

Condition

Alcohol dependence

Intervention

Patients will receive automatically generated personalized SMS via mobile phones twice a week for eight weeks. The SMS messages from the study centre are sent to receive information about relapses and need for help as early as possible. Patients are requested to answer within 24h with "B" (no help is needed) or "A" (help is needed or relapse has occurred). They also may send an "emergency-SMS" anytime. In case of sending a "B", or in case of not replying, an e-mail to a therapist will be generated by the system to call the patient by telephone. The therapist will then provide brief telephone counselling and may recommend routinely existing and available interventions (support, brief interventions, outpatient treatment or readmission).

Control group receives treatment as usual (TAU) only.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Level of alcohol consumption: attainment of low-risk alcohol consumption rates (males: <= 30 g alcohol/typical drinking day; females: <= 20 g alcohol/typical drinking day) as measured with FORM-90 AQ/AT by telephone in the time interval between four and eight weeks after discharge from hospital.

Secondary outcome measures

1. Number of drinking days
2. Standard consumption units per consumption day
3. Number of heavy drinking episodes
4. Utilisation of treatment services

Overall trial start date

27/05/2009

Overall trial end date

08/05/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with alcohol dependence (ICD-10)
2. Inpatient alcohol detoxification treatment
3. Male or female adult patients aged >= 18 years, legally competent
4. Able to read and send SMS messages and answer questionnaires
5. Written informed consent of the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

27/05/2009

Recruitment end date

08/05/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Hospital for Psychiatry and Psychotherapy
Stralsund
18437
Germany

Sponsor information

Organisation

University Medicine Greifswald (Germany)

Sponsor type

University/education

Website

http://www.uni-greifswald.de

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital for Psychiatry and Psychotherapy, Greifswald University Medicine, HELIOS Hanseklinikum Stralsund (Germany)