Angelina Isabella Mellentin1,2,3,4, Silke Behrendt5,6, Randi Bilberg5,7, Matthijs Blankers8,9,10, Marie Paldam Folker11, Kristine Tarp11, Jakob Uffelmann12, Anette Søgaard Nielsen5,7,13,14. 1. Department of Clinical Research, Unit of Clinical Alcohol Research, University of Southern Denmark, Odense, Denmark. amellentin@health.sdu.dk. 2. Psychiatric University Hospital, University Function, Region of Southern Denmark, Odense, Denmark. amellentin@health.sdu.dk. 3. Research Unit for Telepsychiatry and E-mental Health, Centre for Telepsychiatry in the Mental Health Services in the Region of Southern Denmark and Department of Clinical Research, University of Southern Denmark, Odense, Denmark. amellentin@health.sdu.dk. 4. Department of Clinical Research, I BRIDGE, Brain Research, Inter-Disciplinary Guided Excellence, University of Southern Denmark, Odense, Denmark. amellentin@health.sdu.dk. 5. Department of Clinical Research, Unit of Clinical Alcohol Research, University of Southern Denmark, Odense, Denmark. 6. Institute for Psychology, University of Southern Denmark, Odense, Denmark. 7. Psychiatric University Hospital, University Function, Region of Southern Denmark, Odense, Denmark. 8. Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands. 9. Department of Psychiatry, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands. 10. Trimbos Institute - The Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands. 11. Research Unit for Telepsychiatry and E-mental Health, Centre for Telepsychiatry in the Mental Health Services in the Region of Southern Denmark and Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 12. Sundhed.dk, Copenhagen, Denmark. 13. Department of Clinical Research, I BRIDGE, Brain Research, Inter-Disciplinary Guided Excellence, University of Southern Denmark, Odense, Denmark. 14. OPEN, Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
Abstract
BACKGROUND: A major challenge to psychological treatment for alcohol use disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD. AIMS: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only. METHODS: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n = 1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on sociodemographics, treatment (e.g. intensity, duration), type of treatment conclusion (compliance vs. dropout), alcohol consumption, addiction severity, consequences of drinking, and quality of life, will be collected at treatment entry, at treatment conclusion, and 6 months after treatment conclusion. The primary outcome is compliance at treatment conclusion, and the secondary outcomes include alcohol consumption and quality of life at six-months follow-up. Data will be analyzed with an Intention-to-treat approach by means of generalized linear mixed models with a random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted. DISCUSSION: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and when successful, blended treatment has the potential to become an alternative offer in many outpatient clinics nationwide and internationally. TRIAL REGISTRATION: Clinicaltrials.gov .: NCT04535258 , retrospectively registered 01.09.20.
RCT Entities:
BACKGROUND: A major challenge to psychological treatment for alcohol use disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD. AIMS: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only. METHODS: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n = 1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on sociodemographics, treatment (e.g. intensity, duration), type of treatment conclusion (compliance vs. dropout), alcohol consumption, addiction severity, consequences of drinking, and quality of life, will be collected at treatment entry, at treatment conclusion, and 6 months after treatment conclusion. The primary outcome is compliance at treatment conclusion, and the secondary outcomes include alcohol consumption and quality of life at six-months follow-up. Data will be analyzed with an Intention-to-treat approach by means of generalized linear mixed models with a random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted. DISCUSSION: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and when successful, blended treatment has the potential to become an alternative offer in many outpatient clinics nationwide and internationally. TRIAL REGISTRATION: Clinicaltrials.gov .: NCT04535258 , retrospectively registered 01.09.20.
Authors: Scott D Ramsey; Richard J Willke; Henry Glick; Shelby D Reed; Federico Augustovski; Bengt Jonsson; Andrew Briggs; Sean D Sullivan Journal: Value Health Date: 2015-03 Impact factor: 5.725
Authors: M F Janssen; A Simon Pickard; Dominik Golicki; Claire Gudex; Maciej Niewada; Luciana Scalone; Paul Swinburn; Jan Busschbach Journal: Qual Life Res Date: 2012-11-25 Impact factor: 4.147
Authors: Heleen Riper; Adriaan Hoogendoorn; Pim Cuijpers; Eirini Karyotaki; Nikolaos Boumparis; Adriana Mira; Gerhard Andersson; Anne H Berman; Nicolas Bertholet; Gallus Bischof; Matthijs Blankers; Brigitte Boon; Leif Boß; Håvar Brendryen; John Cunningham; David Ebert; Anders Hansen; Reid Hester; Zarnie Khadjesari; Jeannet Kramer; Elizabeth Murray; Marloes Postel; Daniela Schulz; Kristina Sinadinovic; Brian Suffoletto; Christopher Sundström; Hein de Vries; Paul Wallace; Reinout W Wiers; Johannes H Smit Journal: PLoS Med Date: 2018-12-18 Impact factor: 11.069
Authors: Rosalie van der Vaart; Marjon Witting; Heleen Riper; Lisa Kooistra; Ernst T Bohlmeijer; Lisette J E W C van Gemert-Pijnen Journal: BMC Psychiatry Date: 2014-12-14 Impact factor: 3.630