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| [ Print-friendly version ] |
| SMS study for alcohol dependence |
| ISRCTN | ISRCTN78350716 |
| ClinicalTrials.gov identifier | |
| Public title | SMS study for alcohol dependence |
| Scientific title | Continuity of care among alcohol dependent patients via mobile phone SMS: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | German Research Fund (DFG) Lu 849/2-1 |
| 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. |
| Lay 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 |
| 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 |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Alcohol dependence; alcohol withdrawal |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2012 |
| Anticipated end date | 31/12/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 462 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) (Lu 849/2-1) |
| Trial website | |
| Publications | |
| Contact name | Dr Michael Lucht |
| Address |
Hospital for Psychiatry and Psychotherapy
University of Greifswald Haus 30 Rostocker Chaussee 70 |
| City/town | Stralsund |
| Zip/Postcode | 18437 |
| Country | Germany |
| lucht@uni-greifswald.de | |
| Sponsor | German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) |
| Address | Kennedyallee 40 |
| City/town | Bonn |
| Zip/Postcode | 53175 |
| Country | Germany |
| postmaster@dfg.de | |
| Sponsor website: | http://www.dfg.de |
| Date applied | 18/11/2011 |
| Last edited | 24/01/2012 |
| Date ISRCTN assigned | 24/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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