Condition category
Mental and Behavioural Disorders
Date applied
18/11/2011
Date assigned
24/01/2012
Last edited
13/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Alcohol dependence is a common disease with high rates of recovery but some patients may have many relapses. Not only is there a high risk of recurrent alcohol consumption after inpatient detoxification, but 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. German counselling services may lose track of their patients. Feelings of guilt and shame and physical inability also constitute a barrier to treatment. Outreach services (home visits) are costly and therefore not common. One solution could be a mobile phone based system.

Who can participate?
Patients (age >=18 y) with alcohol dependence after inpatient alcohol detoxification in one of the participating hospitals in Rostock, Schwerin, Greifswald and Stralsund. Patients with dementia, acute psychoses and current use of illegal drugs cannot participate.

What does the study involve?
Patients are randomly assigned to one of two groups. In group 1, patients will receive automatically generated personalized mobile phone SMS: in month 1-2 twice a week, in month 3 once a week, and in months 4 to 12 every second week. Patients have to answer within 24h with "N" (no help is needed) or "J" (help is needed or relapse has occurred). They also may send an "emergency SMS" anytime. In this case, an e-mail will be sent to a therapist who will call the patient by telephone. The therapist will then provide brief telephone counselling and may recommend existing treatments (support, brief interventions, outpatient treatment or readmission). Patients sending "N" receive an automatically generated supporting SMS. Outcome parameters are assessed by a telephone studio 4 times during the following year. There is no exchange of information between therapists of the study and collaborators of the telephone studio. 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?
Bethanien Hospital for Psychiatry and Psychotherapy, Odebrecht Foundation, Greifswald, Jens Langosch, MD; HELIOS Hospital Schwerin, Hospital for Addictive Disorders, Markus Stuppe, MD; Hospital for Psychiatry and Psychotherapy, University of Rostock, Rostock, Jacqueline Höppner, MD; Hospital for Psychiatry and Psychotherapy, University of Greifswald, Stralsund; Michael Lucht, MD
Lead centre: Hospital for Psychiatry and Psychotherapy, University of Greifswald

When is study starting and how long is it expected to run for?
Anticipated start date: 12/2011. Approximate duration of the trial: 30 months
The trial will be recruiting patients for 18 months

Who is funding the study?
German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG)

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 of Greifswald
Haus 30
Rostocker Chaussee 70
Stralsund
18437
Germany
-
lucht@uni-greifswald.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

German Research Fund (DFG) Lu 849/2-1

Study information

Scientific title

Continuity of care among alcohol dependent patients via mobile phone SMS: a randomised controlled trial

Acronym

Study hypothesis

Evaluate the efficacy of a 12-months standardized outpatient interactive mobile phone SMS intervention to increase abstinence and non-hazardous drinking (according to WHO criteria) rates in month 10-12 after randomisation in alcohol dependent patients after initial routine inpatient detoxification.

Ethics approval

1. Ethics Committee of the University of Greifswald (Ethikkommission der Ernst-Moritz-Arndt Universität Greifswald) Friedrich-Löffler-Str, 17489 Greifswald approved on July 28th, 2011, Ref.-Nr. BB 79/11
2. Ethics Committee of the University of Rostock (Ethikkommission an der Medizinischen Fakultät der Universität Rostock), St.-Georg-Str. 108
,18055 Rostock, Germany approved on August 18th, 2011; Ref.-Nr. A 2011 99

Study design

Randomised controlled two-armed multi-centre (four hospitals) ratio of intervention to control-group of 1:1

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Alcohol dependence; alcohol withdrawal

Intervention

Patients will receive automatically generated personalized SMS over mobile phones with the following regimen: in month 1-2 twice a week, in month 3 once a week, and in months 4 to 12 every second week. The SMS messages from the study centre are sent to receive information about relapses and need for help as early as possible. Patients have to answer within 24h with "N" (no help is needed) or "J" (help is needed or relapse has occurred). They also may send an "emergency-SMS" anytime. In case of sending “J”, 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).

Therapists of four hospitals in Mecklenburg-Pomerania will receive training for brief telephone counselling. A manual is provided detailing interventions to be recommended to the patient. Patients sending "N" receive an automatically generated supporting SMS.

Control group receives treatment as usual (TAU) only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Level of alcohol consumption” with three ordered categories abstinence < non-hazardous
drinking < hazardous drinking, using the WHO criteria of hazardous drinking of > 60g/day for males and > 40 g/day for females, in months 10 to 12 after randomization

Secondary outcome measures

1. Cumulative drinking days
2. Standard consumption units
3. Number of heavy drinking episodes
4. Time to first heavy drinking episode
5. Utilisation of treatment services
6. Self-rated health quality
7. Craving
8. Social characteristics such as partnership and housing

Overall trial start date

01/01/2012

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Alcohol dependence [Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)]
2. Inpatient alcohol detoxification treatment
3. Male or female adult patients aged >18 years, legally competent
4. Able to read and send SMS messages
5. Written informed consent of the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

462

Participant exclusion criteria

1. Expected noncompliance to the planned assessments
2. Acute withdrawal from illegal drugs within the last 6 months (amphetamines, cannabinoids, morphine, cocaine etc.); nicotine and benzodiazepines are no reason for exclusion
3. Participation in a drug substitution (e.g. methadone) program
4. Severe mental problems, particularly active psychoses and dementia
5. Life expectancy < 12 months due to severe comorbidities
6. Concomitant participation in other clinical trials before inclusion

Recruitment start date

01/01/2012

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Hospital for Psychiatry and Psychotherapy
Stralsund
18437
Germany

Sponsor information

Organisation

German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53175
Germany
-
postmaster@dfg.de

Sponsor type

Government

Website

http://www.dfg.de

Funders

Funder type

Government

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) (Lu 849/2-1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24730528

Publication citations

Additional files

Editorial Notes