Brief multimodal psychosomatic therapy in patients with medically unexplained symptoms: feasibility and treatment effects.

BACKGROUND: Patients repeatedly presenting with medically unexplained symptoms (MUS) to their GPs, suffer from their symptoms. Experts in the field suggest a multicomponent approach for these patients. Brief multimodal psychosomatic therapy (BMPT) is such an intervention. OBJECTIVES: To test the systematic identification of eligible patients, acceptability of BMPT and potential treatment effects of BMPT. METHODS: The participants in this randomized pilot trial, patients consulting their GPs more than once with MUS, were randomized to intervention [usual care (UC) and additional BMPT] or control condition (UC alone).We monitored the number of patients identified and recruited, trial recruitment and retention. Potential treatment effects were measured with perceived symptom severity [Visual Analogue Scale (VAS)]; patients' self-rated symptoms of distress, depression, anxiety and somatization [Four-Dimensional Symptom Questionnaire (4DSQ)]; symptoms of hyperventilation [Nijmegen Hyperventilation List (NHL)]; physical and mental health status and quality of life [Short-Form Health Survey-36 items (SF-36)]; and level of functioning (measure of general functioning). Follow-up was 1 year. RESULTS: A total of 42 patients could be included in the trial. Four patients withdrew after randomization and two patients were lost to follow-up, resulting in 36 patients (86%). During the 12-month follow-up after BMPT, there was an improvement in perceived symptom severity [adjusted mean difference -2.0, 95% confidence interval (CI) -3.6 to -0.3], in somatization (adjusted mean difference -4.4, 95% CI -7.5 to -1.4) and in symptoms of hyperventilation (adjusted mean difference -5.7, 95% CI -10.5 to -0.8). CONCLUSIONS: This randomized pilot study shows that a larger trial studying the effectiveness of BMPT in patients with MUS in primary care is feasible and useful.

Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care.

OBJECTIVE: To evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS). METHODS: We conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6-12 sessions delivered by specialised exercise- and physiotherapists. PRIMARY OUTCOME MEASURE: patient's level of functioning. SECONDARY OUTCOMES: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts. RESULTS: Compared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference - 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference - 1.93 [95% CI -3.81 to -0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference - 0.91 [95% CI -1.78 to -0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups. CONCLUSION: We only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study. TRIAL REGISTRATION: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356.

Perceived working mechanisms of psychosomatic therapy in patients with persistent somatic symptoms in primary care: a qualitative study.

OBJECTIVES: To explore the perceived working mechanisms of psychosomatic therapy according to patients with persistent somatic symptoms (PSS) and their psychosomatic therapists. DESIGN: Qualitative study using semistructured face-to-face interviews and focus groups. All interviews were audiorecorded, transcribed verbatim and analysed, by two researchers independently, based on the thematic analysis. SETTING: Alongside a randomised controlled trial to establish the (cost-)effectiveness of psychosomatic therapy in patients with PSS in primary care, we conducted a process evaluation with a qualitative study. Patients were recruited in general practice in three regions in the Netherlands. PARTICIPANTS: Interviews were conducted with twenty patients with PSS who received psychosomatic therapy and 25 psychosomatic therapists. In addition, two focus groups were conducted with six and seven psychosomatic therapists, respectively. INTERVENTION: Psychosomatic therapy, delivered by specialised exercise and physical therapists, is a multimodal and tailored treatment based on the biopsychosocial model. OUTCOME MEASURES: Experiences, opinions and views from patients' and therapists' perspective on psychosomatic therapy were identified. RESULTS: A total of 37 interviews with patients, 25 interviews and two focus groups with therapists were analysed. Three main themes emerged from the data of the patients: (1) continuous alternation of psychosocial conversations and body-oriented exercises; (2) awareness of body-mind connection and (3) good relationship with therapist. Four main themes emerged from the data of the therapists (1) building rapport; (2) continuously searching for common ground; (3) making patients aware of the interaction between body and mind; and (4) continuous alternation between exploration and treatment. CONCLUSION: According to patients as well as therapists, the continuous alternation of psychosocial conversations and body-oriented exercises to provide awareness of the interaction between body and mind are the perceived working mechanism of psychosomatic therapy. Therapeutic alliance and finding common ground between patient and therapist are prerequisites for the success of psychosomatic therapy. TRIAL REGISTRATION NUMBER: NL7157 (NTR7356).

Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial.

BACKGROUND: Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient's acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is cost- effective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS. METHODS: A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30-45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. DISCUSSION: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS. TRIAL REGISTRATION: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.

Cost-effectiveness of interventions for medically unexplained symptoms: A systematic review.

BACKGROUND: In primary and secondary care medically unexplained symptoms (MUS) or functional somatic syndromes (FSS) constitute a major burden for patients and society with high healthcare costs and societal costs. Objectives were to provide an overview of the evidence regarding the cost-effectiveness of interventions for MUS or FSS, and to assess the quality of these studies. METHODS: We searched the databases PubMed, PsycINFO, the National Health Service Economic Evaluation Database (NHS-EED) and the CEA registry to conduct a systematic review. Articles with full economic evaluations on interventions focusing on adult patients with undifferentiated MUS or fibromyalgia (FM), irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS), with no restrictions on comparators, published until 15 June 2018, were included. We excluded preventive interventions. Two reviewers independently extracted study characteristics and cost-effectiveness data and used the Consensus on Health Economic Criteria Checklist to appraise the methodological quality. RESULTS: A total of 39 studies out of 1,613 articles met the inclusion criteria. Twenty-two studies reported costs per quality-adjusted life year (QALY) gained and cost-utility analyses (CUAs). In 13 CUAs the intervention conditions dominated the control conditions or had an incremental cost-effectiveness ratio below the willingness-to-pay threshold of € 50,000 per QALY, meaning that the interventions were (on average) cost-effective in comparison with the control condition. Group interventions focusing on MUS (n = 3) or FM (n = 4) might be more cost-effective than individual interventions. The included studies were heterogeneous with regard to the included patients, interventions, study design, and outcomes. CONCLUSION: This review provides an overview of 39 included studies of interventions for patients with MUS and FSS and the methodological quality of these studies. Considering the limited comparability due to the heterogeneity of the studies, group interventions might be more cost-effective than individual interventions. REGISTRATION: Study methods were documented in an international prospective register of systematic reviews (PROSPERO) protocol, registration number: CRD42017060424.