Mindful body trial

Summary of thesis

Medically unexplained symptoms are symptoms for which no clear biomedical cause has been identified. In general, doctors have great difficulty dealing with patients with persistent medically unexplained symptoms. These patients often feel strongly impaired by their symptoms and they have a relatively high health care use, they receive many medical investigations and interventions. This leads to a high risk for adverse effects. The high healthcare use also leads to considerable healthcare costs. An intervention directed at this specific group of patients has the potential to have large societal and individual impact. In this thesis we have studied ways of identifying patients with persistent medically unexplained symptoms, we have explored the views of these patients upon health care and we have examined the effectiveness of diagnostic tests as a way of reassuring patients. In addition, we have examined a new intervention for patients with medically unexplained symptoms: mindfulness-based cognitive therapy (MBCT). The main aim of this thesis was to study the feasibility, effectiveness and the cost effectiveness of mindfulness training for patients with persistent medically unexplained symptoms. Furthermore, we wanted to gain a deeper understanding of the working mechanisms of MBCT for patients with persistent medically unexplained symptoms (MUS). It is a challenge for physicians to improve their competence in recognizing and managing patients with somatoform disorders, and a screening questionnaire for somatoform disorders might be helpful.

In chapter 2 we present our study examining whether the PHQ-15 is a suitable questionnaire for the detection of somatoform disorders in a high-risk primary care population. The study shows that the PHQ-15 is a valid and moderately reliable questionnaire for the screening of patients in a primary care setting at risk for somatoform disorders. The positive predictive value of the PHQ-15 for a somatoform disorder was 21%. With little evidence available on the experiences of patients with persistent MUS, we interviewed 17 patients with a long history of presenting MUS in chapter 3. The patients wanted to be taken seriously by their GP, they wanted to be partners in decision making and expected ongoing guidance from their GP. In addition, they wanted prevention of further suffering and a clear explanation for what was going on. The participants showed a relatively high level of health anxiety. They expected their GP to react quickly to their symptoms and, if necessary, to use diagnostic tests. These patients seem to have a high level of distress intolerance. New interventions for persistent MUS might focus on improving the doctor-patient relationship and on increasing the patient’s acceptance of symptoms.

In chapter 4, we examined whether diagnostic tests lead to increased reassurance of patients by performing a systematic review. In total, five randomized controlled trials examined the reassuring value of a diagnostic test. The trials used different diagnostic tests for different frequently presented physical symptoms. Four out of five trials did not find a significant reassuring value of the diagnostic tests. One study reported a reassuring effect at three months, but this had disappeared after one year. The results point in the direction of diagnostic tests making hardly any contribution to the level of reassurance of patients. Diagnostic tests are easily available and might seem to be a good instrument to reassure patients, but the reassuring effect of diagnostic tests is limited. Patients with persistent MUS make heavy demands on the health care system. Cognitive behavioral therapy (CBT) has been proven to be effective, but an off er for psychological treatment is often declined because these patients do not expect an improvement from psychological treatment. Thus, there is a need for acceptable and effective treatments for persistent MUS. Mindfulness-based cognitive therapy (MBCT) is a relatively new development within the fi eld of medicine. It consists of meditation, yoga exercises and psycho-education during eight weekly group sessions and daily homework exercises. MBCT facilitates participants in developing the ability to tolerate symptoms while at the same time not letting the symptoms dictate behavior. MBCT is a group based skills training program intended to enable participants to become more aware of their bodily sensations, thoughts, and feelings. It has a body focused and experiential approach, which is diff erent from CBT. MBCT might be acceptable to patients with MUS because it is off ered as a group training that is directed towards the body to enhance self-care rather than as a psychological treatment. Previous studies have demonstrated the eff ectiveness of MBCT for patients with depressive and anxiety disorders, fi bromyalgia, chronic pain and chronic fatigue syndrome. MBCT might also be eff ective for patients with persistent medically unexplained symptoms.

Chapter 5 describes the primary results of our randomized controlled trial (RCT). We performed a randomized controlled trial investigating the feasibility and effectiveness of mindfulness-based cognitive therapy (MBCT) on patients with persistent MUS. Nineteen gPs in the area of Nijmegen participated. They selected patients with MUS from their 10% most frequent attenders. These patients were invited to participate in the trial. Patients who were interested, were seen for a research interview. 125 Patients were randomized over two conditions: receiving MBCT or receiving enhanced usual care (EUC). Participants receiving MBCT had a significant greater improvement in mental functioning at the end of the training, specifically vitality and social functioning improved. Physical functioning and general health status did not diff er between groups. We conclude that MBCT was feasible for these frequently attending patients with persistent MUS. MBCT led to clinically relevant improvements in mental functioning.

 

In chapter 6, we present the results of the economic analysis performed alongside the RCT. We performed a cost-effectiveness analysis with a time horizon of one year from a societal perspective. MBCT led to a small increase in quality adjusted life years (QALy) and slightly higher societal costs. Participants in the MBCT condition used re[1]latively more mental health care and less hospital care than participants in the control condition. The shift in health care use might lead to more effective care for patients with persistent MUS. At a willingness to pay of € 80,000 per QALy, the probability that MBCT was cost-effective is 57%. MBCT is a relatively cheap intervention, in our study MBCT was more cost-effective than usual care within one year. To reach a deeper understanding of the findings of the RCT we performed a qualitative study examining how mindfulness training works in patients with persistent MUS. In chapter 7 we present a theoretical model which was derived from the analysis of different sources: longitudinal interviews with participants and observational reports of two researchers who attended a full MBCT course. In total, 35 qualitative interviews were carried out. MBCT initiated a process of change, starting with awareness of the present moment, the associated sensory experiences, thoughts and emotions, and accepting rather than resisting these. Participants started to recognize their own behavioral patterns and change them, thus improving self care. In some participants we noticed an increase in self[1]compassion. Main barriers were concurrent social problems and the inability or unwillingness to accept symptoms. Whereas before MBCT patients with MUS focused on short term symptom relief, MBCT created an opportunity for many of them to accept symptoms as a part of life. At the same time these patients took better care of themselves.

Defense

The defense was in 2013.

 
 
 

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