title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ISRCTN10323951.
authors.affiliation: Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Schaub
authors.affiliation: Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Matthijs
authors.initials: M
authors.lastname: Blankers
authors.affiliation: Department of Health Psychology and Applied Biological Psychology, Leuphana University Lueneburg, Lueneburg, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Lehr
authors.affiliation: Division of Health Training Online, Innovation Incubator, Leuphana University Lueneburg, Lueneburg, Germany.
authors.forename: Leif
authors.initials: L
authors.lastname: Boss
authors.affiliation: Division of Health Training Online, Innovation Incubator, Leuphana University Lueneburg, Lueneburg, Germany.
authors.forename: Heleen
authors.initials: H
authors.lastname: Riper
authors.affiliation: Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
authors.forename: Jack
authors.initials: J
authors.lastname: Dekker
authors.affiliation: Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Anna E
authors.initials: AE
authors.lastname: Goudriaan
authors.affiliation: Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
authors.forename: Larissa J
authors.initials: LJ
authors.lastname: Maier
authors.affiliation: Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
authors.forename: Severin
authors.initials: S
authors.lastname: Haug
authors.affiliation: Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
authors.forename: Manuel
authors.initials: M
authors.lastname: Amann
authors.affiliation: Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
authors.forename: Michelle
authors.initials: M
authors.lastname: Dey
authors.affiliation: Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wenger
authors.affiliation: Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen Nuremberg, Erlangen, Germany.
authors.forename: David D
authors.initials: DD
authors.lastname: Ebert
mesh_terms: D000437:Alcoholism / Q000517:prevention & control*; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D003863:Depression / Q000517:prevention & control*; D017831:Diagnosis, Dual (Psychiatry); D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D020407:Internet; D008297:Male; D062405:Motivational Interviewing; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D055502:Secondary Prevention / Q000191:economics* / Q000379:methods*; D016896:Treatment Outcome; D014584:User-Computer Interface
keywords: Alcohol; Internet; behavioural self-management; cognitive behavioural therapy; motivational interviewing