Relating Therapy for distressing auditory hallucinations: A pilot randomized controlled trial
Introduction
Auditory hallucinations (AH) are reported by the majority of patients with Schizophrenia Spectrum Disorder (Thomas et al., 2007) and are also common in other psychiatric disorders (Sommer et al., 2012). This symptom can have a devastating effect on patients' lives due to high levels of distress (Birchwood and Chadwick, 1997), depression (Birchwood et al., 2004) and an increased risk of suicide (Kjelby et al., 2015). Patients with persistent AH report the reduction of distress to be a priority for treatment (Greenwood et al., 2010, Meddings and Perkins, 2002).
NICE recommend antipsychotic medication and Cognitive Behaviour Therapy for Psychosis (CBTp) for the treatment of ‘positive’ symptoms of schizophrenia, including AH (National Collaborating Centre for Mental Health, 2014). Despite evidence for its benefits, antipsychotic medication is often not fully effective, and 40–50% of patients are non-adherent (Lacro et al., 2002). CBTp has evidence from 12 meta-analyses that suggest small to moderate effects (ranging from Hedges g = 0.09 to 0.49 depending on trials included and outcomes examined). However, CBTp as a broad approach has not consistently reduced AH distress (Mawson et al., 2010).
To better target AH outcomes, a symptom-specific approach that focuses on key processes hypothesized to be associated with adaptation to persisting AH is needed (Thomas et al., 2014). Such an approach has been used successfully with paranoid delusions (Freeman et al., 2015) and has resulted in larger effect sizes than broader CBT approaches (Mehl et al., 2015). For AH, a large and methodologically robust trial of Cognitive Therapy for Command hallucinations (CTCH) has successfully utilized a symptom-specific and mechanism-focused approach to reduce the targeted outcome of behavioural compliance with command hallucinations (Birchwood et al., 2014). However, this study reported no reduction in AH distress. Avatar Therapy (Leff et al., 2013) and Competitive Memory Training (COMET) (Van Der Gaag et al., 2012) are also psychological therapies that have specifically focused upon AH. Whilst they have reported encouraging findings from pilot studies, neither has targeted or reported specific outcomes for AH distress.
We have drawn upon Birtchnell's Relating Theory (Birtchnell, 2001) and Birchwood's interpersonal CBT model of AH (Birchwood et al., 2004) to develop Relating Therapy (RT) as a symptom-specific therapy that targets interpersonal relating as a mechanism associated with AH distress. An evolving literature has explored AH within relational frameworks and patients have been found to have subordinating and intrusive relationships with their AH (Hayward et al., 2011). These relationships are associated with distress (Sorrell et al., 2010), share similarities with patient's relationships with people within their social environments (Birchwood et al., 2004, Hayward, 2003), and are often maintained by the submissive (Hayward et al., 2008) and/or aggressive (Thomas et al., 2009) responses of the patient. Relating Therapy has been developed to modify the ‘negative relating’ of the patient through the teaching of assertiveness skills. An initial case series found Relating Therapy to be intuitive and acceptable to patients and therapists (Hayward and Fuller, 2010, Hayward et al., 2009).
Within this pilot RCT we sought to generate a descriptive summary of the primary and secondary outcomes to provide robust estimates of variability to inform calculations for a subsequent fully powered phase 3 trial. We also explored differences in outcomes between groups and changes over time.
Section snippets
Study design
This was a pilot study for conducting a single-blind, pragmatic, parallel groups, superiority RCT comparing Relating Therapy plus treatment as usual (hereafter referred to as RT) with treatment as usual alone (hereafter referred to as TAU). Eligible participants were recruited from one mental health centre in Sussex, UK. Recruitment began in June 2013 and was completed in February 2015. Follow-up assessments began in April 2014 and were completed in November 2015. Assessments were completed
Results
The CONSORT diagram shows the trial profile (see Fig. 1). A total of 57 patients were referred to the study, 41 (72%) were assessed for eligibility, with the remaining 16 (28%) patients being non-contactable or not wishing to take part in the study.
The demographic and clinical characteristics of the study sample can be found in Table 1. The majority of the participants had a diagnosis of Schizophrenia Spectrum Disorder and all had been hearing AH for more than five years. The sample was similar
Discussion
This study aimed to inform the parameters of a larger, suitably powered phase 3 trial assessing the effectiveness of RT in reducing AH distress in comparison to TAU for patients with persistent and distressing AH. The large effect size for the primary outcome in favour of the treatment arm, and maintained at follow-up suggests that RT may be clinically effective in reducing AH distress. Medium-large effect sizes for some of the secondary clinical outcomes and the process measures in favour of
Trial registration
Current Controlled Trials ISRCTN registration number 44114663 on 13th June 2013.
Contributors
AJ completed the statistical analysis. MH completed the first draft of the report with input from NT, CS and LBJ.
Conflict of interest
None.
Role of the funding source
This study was funded by the British Academy (SG121682) and Sussex Partnership NHS Foundation Trust.
Acknowledgements
Thanks are due to Cassie Hazell for the collection of data, to David Fowler for helpful comments on the manuscript and to the participants for volunteering to take part in the study.
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