Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMJ Open. 2021 Mar 24;11(3):e044244. doi: 10.1136/bmjopen-2020-044244.
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.
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 1 month, 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 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.
DRKS00018803.
持续性躯体症状（PSS）在普通人群和初级保健中都很常见。它们在心理和躯体症状负担方面令人烦恼。由于缺乏针对 PSS 的科学支持的解释模型，或者仅关注投诉的躯体方面，健康专业人员在沟通方面常常感到困难，这两种情况都使患者的需求得不到满足。因此，本研究的目的是基于当前基于证据的解释模型开发一种心理教育干预措施，检验其可行性，并为大规模随机对照试验奠定基础。
在一项随机对照混合方法的试点试验中，将有 75 名患有 PSS（症状持续时间≥6 个月）和伴随心理症状（躯体症状 B 标准量表总分≥18）和躯体症状负担（患者健康问卷-15 得分>10）的成年身心科门诊患者，且无前期身心治疗史的患者符合条件。参与者将接受或不接受个性化元素的解释模型（干预组 1，n=25；干预组 2，n=25）。对照组（n=25）的参与者将获得关于当前 PSS 指南的信息。参与者将对分组和干预措施进行盲法评估，这些干预措施将在门诊诊所的平板电脑上展示。1 个月后，将进行定性随访电话访谈。主要结局是定量比较各组之间心理和躯体症状负担的平均变化。使用定量和定性措施评估三种干预措施的行为改变机制和可行性。
汉堡医疗协会医学伦理委员会（PV5653）已批准该伦理。本研究的结果将发表在同行评议的期刊上，并在国内外会议上展示。
DRKS00018803。
