Adherence therapy following an acute episode of schizophrenia: A multi-centre randomised controlled trial Michael Schulz a, b , Richard Gray c, ⁎, Alexa Spiekermann d , Christoph Abderhalden e , Johann Behrens f , Martin Driessen b a University of Applied Sciences–Welfare and Social Work, Bielefeld, Germany b Department of Psychiatry and Psychotherapy Bethel, Bielefeld, Germany c University of the West of England, England, United Kingdom d Cologne, Germany e University of Bern Psychiatric Services, Berne, Switzerland f Martin-Luther-University Halle Wittenberg, Germany abstract article info Article history: Received 22 August 2012 Received in revised form 14 January 2013 Accepted 30 January 2013 Available online xxxx ISRCTN: 76324634 Keywords: Adherence Compliance Antipsychotic Schizophrenia Background: Non-adherence with antipsychotic medication is common in patients with schizophrenia. Aims: To establish the efficacy of adherence therapy (AT) compared to treatment as usual (TAU) in improving medication compliance in patients following an acute episode of schizophrenia. Method: The study was designed as a parallel group, single blind, randomised controlled trial. Fieldwork was conducted in four centres (3 in Germany and 1 in Switzerland) and involved a total of 161 patients. Patients received 8 sessions of AT in addition to treatment as usual. The main outcomes of this study were adherence and psychopathology at 12 weeks post discharge follow up. Results: In total 80 patients received AT and 57 TAU. Intention-to-treat analysis included all randomised patients. Psychopathology, as determined using the PANSS-total, improved in the AT compared to TAU group by a mean of -6.16 points 12 weeks after discharge from hospital (p b .05). AT had no significant effects on patients' adherence, treatment attitudes or functioning. No significant adverse events were reported. Conclusion: AT improves psychopathology in patients recovering from an acute episode of schizophrenia. © 2013 Elsevier B.V. All rights reserved. 1. Introduction Improving adherence to treatment in patients with schizophrenia has the potential to reduce relapse rates and prolong remission, improve functioning and reduce health care costs (Robinson et al., 1999; David, 2010). Adherence therapy (AT) is a promising candidate intervention that utilises motivational and cognitive behavioural techniques to modify patients' beliefs about treatment to enhance medication adherence (Gray et al., 2004; Gray et al., 2006; Staring et al., 2010; Alhalaiqa et al., 2012; Anderson et al., 2010). The ap- proach is cognisant with the National Institute for Health and Clinical Excellence and WHO guideline and review on promoting adherence in long term conditions (WHO, 2003; Nunes et al., 2009). To date there have been a number of trials of AT in severe mental illness that have produced conflicting findings. For example Gray et al. (2006) in a trial involving 409 patients with schizophrenia found that AT had no effect on the quality of life compared to a health edu- cation control intervention. Although a large, well-conducted trial the intervention was targeted at stable, largely adherent, community dwelling patients and has been criticised for a possible ceiling effect. AT trials that have focused on intervening with patients just after an acute episode (Kemp et al., 1998; Maneesakorn et al., 2007) have gener- ally reported more favourable although not consistently positive out- comes (O'Donell et al., 2003). This observation is consistent with Caplan's crisis theory that suggests that people are more willing to look at alternative perspectives after a life event (such as being admitted to hospital) because they are in a state of confusion and disorganisation (Caplan, 1964). We hypothesised that AT initiated whilst patients with schizophrenia are inpatient and followed up in the community will be ef- fective in enhancing adherence and reducing psychopathology com- pared to usual care. Our randomised controlled trial aimed to test the hypotheses that compared to TAU 12 weeks after discharge from hospital AT: 1. reduces patient levels of psychopathology, 2. leads to an improvement in adherence to treatment, Schizophrenia Research xxx (2013) xxx–xxx ⁎ Corresponding author at: Faculty of Health and Life Sciences, The University of the West of England, Blackberry Hill, Bristol, BS16 1DD, United Kingdom. Tel.: +44 7557 014860. E-mail address: Richard.gray@uwe.ac.uk (R. Gray). SCHRES-05295; No of Pages 5 0920-9964/$ – see front matter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.schres.2013.01.028 Contents lists available at SciVerse ScienceDirect Schizophrenia Research journal homepage: www.elsevier.com/locate/schres Please cite this article as: Schulz, M., et al., Adherence therapy following an acute episode of schizophrenia: A multi-centre randomised controlled trial, Schizophr. Res. (2013), http://dx.doi.org/10.1016/j.schres.2013.01.028