The impact of gender on treatment effectiveness of body psychotherapy for negative symptoms of schizophrenia: A secondary analysis of the NESS trial data
Introduction
Negative symptoms of schizophrenia are strongly associated to social and functional impairment (Hunter and Barry, 2012, Lysaker and Davis, 2004, Milev et al., 2005), and are unresponsive to current treatments (Fusar-Poli et al., 2015). As a result, these symptoms are considered an important unmet therapeutic need in a large proportion of cases (Kirkpatrick et al., 2006). Negative symptoms comprise of two distinct subdomains, with anhedonia, amotivation and asociality representing experiential deficits, and alogia and blunted affect representing expressive deficits (Blanchard and Cohen, 2006, Horan et al., 2011). In the 2014 NICE guidelines (NICE, 2014), creative arts therapies, such as body psychotherapy, were recommended as one effective treatment for negative symptoms. However, in a recent large-scale trial of body psychotherapy, no effects of treatment of negative symptoms were detected (Priebe et al., 2016).
The body psychotherapy NESS trial (Priebe et al., 2016) was an advance on smaller studies by being adequately powered to detect clinically meaningful differences, including 275 participants. The trial had good internal and external validity with a high rating on the Clinical Trials Assessment Measure (88/100), designed to provide quality ratings for psychological treatment studies (Tarrier and Wykes, 2004). The therapy was fully manualised with consistently high treatment fidelity, and the treatment was compared to an active control condition to account for the non-specific effects of structured group activity. Group attendance rates in both arms compared favourably with similar creative arts therapies studies with this patient population (Crawford et al., 2012), while the study retention rate was excellent (96.7% at end of treatment).
Two other randomised controlled trials have been identified as providing data on the effects of body psychotherapy in addition to the NESS trial (Martin et al., 2016, Röhricht and Priebe, 2006). In the Röhricht and Priebe (2006) study large effect size improvements in negative symptoms were detected as compared to a supporting counselling group, with significant improvements in blunted affect and motor retardation evident. In Martin et al. (2016) study, similar effect size improvements were detected relative to treatment-as-usual, with strong improvements found in blunted affect in particular. In NESS, while no effect on negative symptoms was detected, a significant treatment effect on expressive deficits was found, suggesting a greater degree of consistency between the study findings than a first evaluation of the primary outcomes may suggest. Given the current lack of clinically effective treatments for negative symptoms (Fusar-Poli et al., 2015), exploring why this large scale trial did not replicate the findings of the smaller studies may be important in improving recovery opportunities for at least some people with psychosis.
The reason for the differences in outcomes between these studies and the NESS trial is currently unclear. Given physical activity has been found to improve various aspects of psychological wellbeing in schizophrenia (Holley et al., 2011), it is possible that both arms of the NESS study were equally effective. However, the small within-group improvements suggest that this alone cannot account for the differences noted between the studies. A second possibility may relate to variations in the recruited samples. Many of the socio-demographic and clinical characteristics reported in the three studies were similar. One notable exception to this however is that in the full-scale trial a far lower proportion of women were recruited; in the NESS study, 24% of the sample were women, in comparison to 51% in the Röhricht study and 47% in the Martin study. This may be significant, given men have been found to experience significantly poorer premorbid and social functioning (Goldstein and Link, 1988), more pervasive neurodevelopmental abnormalities (Nopoulos et al., 1997), earlier illness onset (Häfner, 2003), are typically less emotionally expressive in response to external stimuli (Kring and Gordon, 1998), and to be more likely to experience extra-pyramidal side effects (Smith, 2010), all of which may impact treatment response in negative symptoms. However, while there is some evidence to suggest that women respond better to antipsychotic treatment (Abel et al., 2010, Usall et al., 2007), and CBT-orientated treatment for depressed patients with chronic pain (Pieh et al., 2012), we could find no studies examining the impact of gender on treatment response in group psychosocial interventions for schizophrenia. While there is some evidence to suggest that negative symptoms are both more severe and more prevalent in males (Galderisi et al., 2012; Morgan et al., 2008), a number of other studies have found no differences between the sexes (see Ochoa et al., 2012), suggesting that negative symptoms remain a significant issue for both men and women.
The primary aim of this study was to assess the moderating effects of gender on body psychotherapy as a treatment for negative symptoms using the NESS data (Priebe et al., 2016). Given the effects of body psychotherapy in the earlier studies have been found predominantly in expressive symptoms such as blunted affect (Martin et al., 2016, Röhricht and Priebe, 2006), analysis on expressive and experiential deficits were considered separately, in addition to assessing negative symptoms as a single construct. In the Röhricht study, clinical improvements were found to occur in negative symptoms only (Röhricht and Priebe, 2006), so an examination of the interaction effect between gender and treatment allocation on positive and general symptoms was completed to examine the specificity of the effect, and the consistency with earlier studies.
Section snippets
Design
The study is a secondary analysis of a blinded, parallel-arm randomised controlled trial. A full description of the design is outlined in the protocol (Priebe et al., 2013), and details of the procedures and study implementation are available in the published full report (Priebe et al., 2016). All participants were randomised, with equal probability, to a 20-session body psychotherapy or Pilates group.
Participants
All participants were outpatients recruited from five different NHS Trusts across the UK. The
Baseline characteristics
The baseline characteristics of the sample, stratified by gender, are presented in Table 1. Of the 275 participants recruited, 203 were men (103 randomised to body psychotherapy and 100 to Pilates) and 72 were women (37 randomised to body psychotherapy and 35 to Pilates).
Impact of gender on treatment outcomes of body psychotherapy on negative symptoms
The mean symptom levels at baseline and end of treatment, stratified by gender, are presented in Table 2. The interaction effect between gender and treatment allocation was found to be significant (Wald's statistic=4.61, p
Main findings
Body psychotherapy was found to significantly reduce negative symptoms of schizophrenia relative to Pilates, however this effect was found only with women. Similar to earlier studies, the improvements were found only to occur in expressive, rather than experiential deficits, whilst no effect of treatment was detected in positive or general psychotic symptoms. These results were consistent after controlling for a number of possible extraneous variables, such as baseline depressive symptoms, EPS,
Conflict of interest
None.
Role of Funding Source
This research was supported by NIMH T32 programme (grant number: MH018261-31). The original data collection was supported by the National Institute for Health Research – Health Technology Assessment (grant number: 08/116/68). The funding sources had no involvement study design; collection, analysis and interpretation of data; the writing of the report; or the decision to submit this article for publication. The views and opinions expressed therein are those of the authors and do not necessarily
Acknowledgements
The authors would like to thank Tabitha Dow, Rebecca Stockley, Josie Davies, Ciara Banks, Nina Papadopoulos, Dr. Christoph Lauber and Dr. Frank Röhricht for their role in the recruitment and implementation of the original study.
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