Efficacy of an internet-based self-help intervention to reduce co-occurring alcohol misuse and depression symptoms in adults: study protocol of a three-arm randomised controlled trial.
- Schaub MP Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
- Blankers M Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
- Lehr D Department of Health Psychology and Applied Biological Psychology, Leuphana University Lueneburg, Lueneburg, Germany.
- Boss L Division of Health Training Online, Innovation Incubator, Leuphana University Lueneburg, Lueneburg, Germany.
- Riper H Division of Health Training Online, Innovation Incubator, Leuphana University Lueneburg, Lueneburg, Germany.
- Dekker J Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
- Goudriaan AE Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
- Maier LJ Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
- Haug S Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
- Amann M Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
- Dey M Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
- Wenger A Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
- Ebert DD Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen Nuremberg, Erlangen, Germany.
- 2016-05-27
Published in:
- BMJ open. - 2016
Alcohol
Internet
behavioural self-management
cognitive behavioural therapy
motivational interviewing
Alcoholism
Cognitive Behavioral Therapy
Cost-Benefit Analysis
Depression
Diagnosis, Dual (Psychiatry)
Female
Humans
Intention to Treat Analysis
Internet
Male
Motivational Interviewing
Psychiatric Status Rating Scales
Research Design
Secondary Prevention
Treatment Outcome
User-Computer Interface
English
INTRODUCTION
In the general population, alcohol use disorder and depression more often occur together than any other combination of a mental illness with a substance use disorder. It is important to have a cost-effective intervention that is able to reach at-risk individuals in the early stages of developing alcohol use disorders and depression disorders.
METHODS AND ANALYSIS
This paper presents the protocol for a 3-arm multicentre randomised controlled trial (RCT) to test the efficacy and cost-effectiveness of the combined internet-based self-help intervention Take Care of You (TCOY) to reduce alcohol misuse and depression symptoms in comparison with a waiting list control group and a comparable intervention focusing on problematic alcohol use only. The active interventions consist of modules designed to reduce alcohol use, based on the principles of motivational interviewing and methods of cognitive behavioural therapy, together with additional modules in the combined study arm to reduce symptoms of depression. Data will be collected at baseline, as well as at 3 and 6 months postrandomisation. The primary outcome is the quantity of alcohol used in the past 7 days. A number of secondary outcome measures will be studied. These include the Centre of Epidemiologic Studies of Depression Scale (CES-D) and a combined measure with the criteria of values below the cut-off for severe alcohol use disorder and for CES-D. Data analysis will follow the intention-to-treat principle using (generalised) linear mixed models. In order to investigate the interventions' cost-utility and cost-effectiveness, a full economic evaluation will be performed.
ETHICS AND DISSEMINATION
This RCT will be executed in compliance with the Helsinki Declaration and has been approved by 2 local Ethics Committees. Results will be reported at conferences and in peer-reviewed publications. Participant-friendly summaries of trial findings will be published on the TCOY websites.
TRIAL REGISTRATION NUMBER
ISRCTN10323951.
In the general population, alcohol use disorder and depression more often occur together than any other combination of a mental illness with a substance use disorder. It is important to have a cost-effective intervention that is able to reach at-risk individuals in the early stages of developing alcohol use disorders and depression disorders.
METHODS AND ANALYSIS
This paper presents the protocol for a 3-arm multicentre randomised controlled trial (RCT) to test the efficacy and cost-effectiveness of the combined internet-based self-help intervention Take Care of You (TCOY) to reduce alcohol misuse and depression symptoms in comparison with a waiting list control group and a comparable intervention focusing on problematic alcohol use only. The active interventions consist of modules designed to reduce alcohol use, based on the principles of motivational interviewing and methods of cognitive behavioural therapy, together with additional modules in the combined study arm to reduce symptoms of depression. Data will be collected at baseline, as well as at 3 and 6 months postrandomisation. The primary outcome is the quantity of alcohol used in the past 7 days. A number of secondary outcome measures will be studied. These include the Centre of Epidemiologic Studies of Depression Scale (CES-D) and a combined measure with the criteria of values below the cut-off for severe alcohol use disorder and for CES-D. Data analysis will follow the intention-to-treat principle using (generalised) linear mixed models. In order to investigate the interventions' cost-utility and cost-effectiveness, a full economic evaluation will be performed.
ETHICS AND DISSEMINATION
This RCT will be executed in compliance with the Helsinki Declaration and has been approved by 2 local Ethics Committees. Results will be reported at conferences and in peer-reviewed publications. Participant-friendly summaries of trial findings will be published on the TCOY websites.
TRIAL REGISTRATION NUMBER
ISRCTN10323951.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1136/bmjopen-2016-011457
- PMID 27225652
- Persistent URL
- https://sonar.ch/global/documents/252235
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