Helpful explanatory models for somatoform symptoms HERMES
AbstractIntroduction Persistent somatic symptoms (PSS) are common both in the general population and primary care. They are bothersome in terms of psychological and somatic symptom burden. Health professionals often struggle with communication, as there is a lack of scientifically supported explanatory models for PSS or a focus merely on somatic aspects of the complaints, which both frustrate patients’ needs. The objective of the present study is therefore to develop a psychoeducational intervention based on a current evidence based explanatory model, to examine its feasibility and form the basis for a large scale randomised controlled trial.Methods and analysis In a randomised controlled mixed methods pilot trial, 75 adult psychosomatic outpatients with PSS (duration of symptoms 6 months) and accompanying psychological (Somatic Symptom B Criteria Scale total score 18) and somatic symptom burden (Patient Health Questionnaire 15 score >10) and no prior psychosomatic treatment will be eligible. Participants will be presented with either the explanatory model without (intervention group 1, n=25) or with elements of personalisation (intervention group 2, n=25). Participants in the control group (n=25) will receive information on current PSS guidelines. Participants will be blinded to group assignment and interventions will be shown on tablet computers at the outpatient clinic. After 1month, qualitative follow up telephone interviews will be conducted. As primary outcomes, mean changes in psychological and somatic symptom burden will quantitatively be compared between groups, respectively. Behavioural change mechanisms and feasibility of the three interventions will be evaluated using quantitative and qualitative measures.Ethics and dissemination Ethics approval has been granted by the medical ethics board of the Hamburg Medical Chamber (PV5653). Results from this study will be published in peer reviewed journals and presented at national and international conferences.psychiatrygeneral medicine (see internal medicine)primary carepreventive medicineStrengths and limitations of this studyThis is the first study to translate a state of the art aetiological model for persistent somatic symptoms (PSS) into an explanatory model that can be used in daily patient care.Feedback both from a patient group and an international expert panel was used during the development of the psychoeducational interventions, which employ means of visualisation and personalisation.The sample will consist of 75 patients with PSS in three experimental groups in order to ensure sufficient power for the pilot trial, using a mixed methods approach.Limitations include the diverse target population with heterogeneous symptom profiles, thus restricting the external validity of the results.The present study is limited to a brief psychoeducational intervention on a tablet computer without further face to face interaction.IntroductionPersistent somatic symptoms (PSS) are marked by long lasting (typically more than 6 months) physical afflictions and sensations and include complaints associated with disorders such as fibromyalgia, irritable bowel syndrome or somatic symptom disorder.1 PSS are a common phenomenon both in the general population and medical settings. At the same time, treatment options are still limited and patients are often regarded as ‘bothersome’ and ‘frustrating’ to work with.2 PSS can affect every organ system and the estimated lifetime prevalence ranges between 5.9% and 16.3% in the general population and specialised settings.3 5 In primary care, approximately 20% of all consultations are estimated to be due to PSS.6 7 PSS are often accompanied by psychological symptoms at cognitive, emotional and behavioural level.8 11 The term PSS in the context of this study summarises PSS that reach diagnostic threshold according to current diagnostic classifications (eg, somatoform disorders),12 13 somatic symptom disorder (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition/DSM 5),14 bodily distress disorder (International Classification of Diseases 11th Revision).15The impairments caused by PSS affect individuals in terms of a significantly reduced quality of life4 and the healthcare system in terms of excessive healthcare costs due to medical consultations and diagnostic procedures.16 Despite their individual and socioeconomic relevance, the majority of affected patients receive no treatment according to hermes replica black clutch
guidelines,17 19 thus enabling a chronic course of disease.20 Additionally, there is a considerable delay between PSS symptom onset and the start of an adequate treatment, that is, psychological interventions.21 22 Further, treatment options for PSS are limited and multidisciplinary treatment as well as non pharmacological interventions show only moderate effect sizes.23 Thus, there is a great need to improve early treatment in PSS.Early interventions usually include psychoeducational material. While there is evidence for the general usefulness of psychoeducational interventions for medically unexplained symptoms (MUS) and functional disorders,24 26 the lack of evidence based explanatory models has been identified as one central barrier in the early treatment of PSS.27 A systematic search of MUS literature identified nine different explanatory models for PSS.28 These explanatory models were based on somatosensory amplification, sensitisation, sensitivity, immune system sensitisation, endocrine dysregulation, the signal filter model, the illness behaviour model, autonomous nervous system dysfunction and abnormal proprioception, and also included one meta model, the cognitive behavioural therapy model. However, most of these models were only partly based on empirical evidence. In primary care, health professionals often feel insecure about the management of patients with PSS.2 They explain the development and maintenance of symptoms only vaguely, and without any references to current aetiological models,29 32 thereby failing patients’ needs for biomedical and tangible explanatory models.29 33 35 When symptom explanations and treatment are not readily available, medical doctors may rely on a defensive biomedical approach in dealing with the symptoms.19 The patients on the other hand may continue to search for the biomedical diagnosis which explains their symptoms,36 that is, examinations for short time reassurance instead of actively engaging in treatment, for example, with the help of knowledge of illness or self management strategies.37Recently, a new aetiological model on PSS was suggested by Henningsen et al.38 While historically, aetiological models of symptom persistence emphasised bottom up processes in a biomedical context and further developed into a biopsychosocial understanding, this new model on PSS focuses on top down processes and conceptualises symptoms as a perceptual dysregulation. It represents a comprehensive biopsychosocial model of PSS and incorporates evidence based findings, that is, by enhancing existing vulnerability stress models and emphasising the role of the patients’ perception and expectations regarding their symptoms. The model has not yet been translated into an explanatory model adapted for the use with patients with PSS. Visual health information is becoming more widely used to communicate information about health and illness to patients. When used in an intervention, it can improve patients’ illness understanding and may ameliorate health behaviour such as adherence to treatment.40 As illness understanding requires a certain level of abstract thinking, visual information may make these intangible processes easier to understand.41 43 Additionally, visual information is often easier to attend to and to be remembered compared with more traditional forms of information.44Apart from visualisation, the provided information should be considered as relevant by the patient, thus increasing the likelihood of it being used. To increase individual relevance, the information has to address needs or fears of the individual,45 should be adjusted to the patients’ level of communication46 and give patients an active choice in the selection of the content.47 Such a person centred, or personalised, approach has been shown to be of value for patients with long term conditions such as PSS.48In conclusion, explanatory models for PSS are thus far not based on current aetiological models, existing knowledge is not available in a way understandable for patients and their practitioners and not designed to suit individual patient needs. However, a current state of the art aetiological model combined with the use of active visualisation and personalisation might be a valuable approach for both patients and their practitioners to communicate explanatory models for PSS.ObjectivesThe primary aim of the HERMES pilot study (full title: Helpful explanatory models in somatoform symptoms) is to explore the feasibility and the impact of an intervention formed on an evidence based explanatory model which can be used as a state of the art early psychoeducational intervention to improve the physical and psychological symptom burden in patients with PSS. We thus translated the aetiological model on PSS suggested by Henningsen et al into an explanatory model that fits both patients’ and practitioners’ needs,35 39 49 50 and that employs means of visualisation. Development of this explanatory model was sustained by the use of feedback both by a patient group and an expert panel, and feasibility of the model will be tested in patients with PSS and their practitioners. Therefore, this study will serve as proof of concept and feasibility study to form the basis for a randomised controlled study, using explanatory models as a starting point to improve early treatment for patients with PSS.51 Additionally, the present study will allow an estimation of randomised controlled trial (RCT) eligibility as well as recruitment and attrition rates. Last, the present study will examine the effect of this newly developed explanatory model both with and without elements of personalised medicine on psychological and physical symptom burden.Study hypothesesThe primary hypothesis is that the presentation of explanatory models for PSS in both experimental conditions results in significantly greater changes in psychological and physical symptom burden between baseline and 1 month follow up compared with the control group. It is further explored whether the additional provision of choice regarding patient information leads to significantly greater changes in psychological and somatic symptom burden compared with an explanatory model without choice. Exploratory analyses will shed light on whether the presentation of explanatory models for PSS in the experimental conditions leads to a significantly greater improvements in quality of life between baseline and 1 month follow up compared with the control condition.Methods and analysisStudy designA pilot RCT was designed to evaluate the influence of evidence based explanatory models for PSS on somatic and psychological symptom burden. Data will be collected at baseline and after 1month. Independent variables will be operationalised through the experimental conditions. At baseline, participants will be randomised into one of three experimental conditions: explanatory model without personalised choice versus explanatory model with personalised choice versus generic PSS information (control group). Primary dependent variables are psychological and physical symptom burden (figure 1).Rationale of the HERMES Study.Open in new tabFigure 1 Rationale of the HERMES Study.Study proceduresInclusion and exclusion criteriaAdult patients aged18 years with PSS (duration6 months) and a sum score of18 in the Somatic Symptom B Criteria Scale (SSD 12)52 and10 in the Patient Health Questionnaire 15 (PHQ 15)53 and thus at risk for somatic symptom disorder54 will be included. Written informed consent will be collected.Exclusion criteria are insufficient knowledge of the German language, current or previous psychotherapeutic treatment of PSS, an acute need for treatment due to other comorbid psychological disorders, and the possibility of acute self harm or endangerment of others.