Cost-effectiveness of psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms

In primary care one-tenth of the attenders account for between 30% and 50% of
consultations. Compared to *normal* attenders, these frequent attenders (FAs)
generate five times as many prescriptions and hospital contacts and they incur
up to five times the health care costs over the preceding 10 years. However,
they still have lower quality of life. FAs often seek medical care with somatic
symptoms not explained by physical disease (i.e. medically unexplained symptoms
(MUS)). These symptoms are often accompanied by psychological, psychiatric,
social(-economic) problems or stressful life events. Verhaak indicated that
2,5% of the patients attending primary care can be classified as persisting
MUS. These patients are at risk for false-positive diagnostic tests and
potentially harmful additional testing and treatment procedures. Medically
Unexplained Symptoms (MUS) have been defined as symptoms of which the origins
remain unclear to a medical doctor after adequate history taking, physical
examination and careful consideration of the psychosocial context. These
symptoms are common in primary and secondary care and associated with enormous
societal costs. Patients with MUS generate costs for the use of healthcare
services of 3123 EUR per patient per year. When work-related costs are taken
into account (absence from work, lower on-the-job productivity and paid
substitution of domestic tasks) the total costs are enlarged to 6815 EUR per
patient per year.
Recently, a Cochrane Review assessed the effects of non-pharmacological
interventions for MUS. This review concludes that when all psychological
therapies included in the review were combined they seem to be superior to
usual care or waiting list in terms of reduction of symptom severity. However,
effect sizes were small and as only CBT has been adequately studied as single
treatment the review only allow tentative conclusions for daily practice.
Furthermore, most patients do not accept CBT as treatment for their MUS. The
authors of the review state that the number of studies investigating various
treatment modalities (other than CBT) needs to be increased and that this is
especially relevant for studies concerning physical therapies.
Psychosomatic therapy is such a physical (multi-component) treatment. This
therapy is administered by physical and exercise therapists with special
interest in MUS. It is a stepped-care and tailor-made approach in which
(psycho)education, relaxation therapy, mindfulness, cognitive behavioural
therapeutic interventions and activating exercise therapy are key elements.
Recently we performed a pilot randomized trial comparing psychosomatic therapy
with usual care in order to study feasibility and treatment effects. Trial
retention as well as acceptability of the intervention was good, as 86% of the
included patients completed the trial and 81% of the patients were (very)
satisfied with the intervention. At 12 month follow-up patients who received
psychosomatic therapy showed significant and clinically relevant improvements
with regard to perceived symptom severity (adjusted mean difference -2.0,
95%CI:-3.6 to -0.3), symptoms of somatisation (adjusted mean difference -4.4,
95%CI: -7.5 to -1.4) and symptoms of hyperventilation (adjusted mean difference
-5.7, 95%CI: -10.5 to -0.8). Aspects of approaches incorporated in
psychosomatic therapy have been shown effective in several studies. A
combination of cognitive behavioural intervention or education and exercise was
found to reduce pain and fatigue and to increase physical functioning and
quality of life in patients with MUS. Mindfulness has shown to improve mental
functioning in patients with MUS. An observational before and after cohort
study by the Dutch psychosomatic therapists association in 119 patients with
MUS demonstrated that patients improve significantly after psychosomatic
therapy (in comparison with baseline scores) on self-rated symptom severity,
symptoms of distress, quality of life, level of functioning, sick leave and use
of medication.

Given the problems GPs are facing when patients with MUS consult them, the risk
of unnecessary medical interventions, the limited prospects for improvement,
and the lack of a therapy acceptable for many patients, a cost-effective
approach in primary care is urgently needed.

In order to guarantee optimal health care for patients who frequently attend
with MUS in primary care, we want to study the cost-effectiveness of
psychosomatic therapy. An effective and acceptable treatment is urgently needed
because (1) these patients are functionally impaired in the absence of an
effective treatment, (2) the proportion of patients who frequently attend
appears to be increasing, and (3) patients are a burden for the health care
system since they generate high, often unnecessary, health care costs.

Aim of the study:
We will evaluate the effects and costs of psychosomatic therapy in primary care
for patients who frequently attend the GP for MUS in improving symptoms and
daily functioning and disability, while reducing consultation frequency and
referrals to secondary care. In addition to the quantitative effectiveness
study, we perform a process evaluation to: a) identify which modules are
actually deployed; b) identify the most effective elements of psychosomatic
therapy and c) understand which patients can benefit from this approach. In a
qualitative project we will examine the experiences of patients as part of
study section b) and c).

The study consists of two phases

Part 1;
Effect and economic evaluation:
We will perform a randomized cost-effectiveness trial in primary care. Patients
(n=158) will be randomized into intervention (psychosomatic therapy in addition
to usual care) or control condition (usual care alone). All patients will be
followed for one year and will be asked to complete questionnaires at baseline,
and at 4 and 12 months follow-up.
The participants will be randomized by a research assistant directly after
receiving the written informed consent. The research assistant will be unaware
of the health status of the participant and will use a computer-generated
permuted block randomization table.

Part 2;
Process evaluation:
We will perform a quantitative and qualitative (sub)study with both therapists
and patients; questionnaires for therapists and interviews with therapists and
participating patients in the interventiongroup.





.

Intervention:
Patients randomised to the intervention group will be invited to attend 6 to 12
sessions of tailor-made psychosomatic therapy lasting 45 minutes each. These
sessions are additional to the usual care for patients with MUS provided by
their GP and other healthcare professionals.
Psychosomatic therapy is administered by Dutch psychosomatic therapists. These
healthcare providers are physical and exercise therapists with special
interests in MUS, respectively from the Dutch association for psychosomatics in
physical therapy (NFP) and the Dutch association for exercise therapists
(VvOCM). Psychosomatic therapy was developed from the broad concept of the
biopsychosocial model in which illness is viewed as a result of interacting
mechanisms at the biomedical, interpersonal and environmental levels.
Psychosomatic therapy is a multi-component, a stepped-care and tailor-made
approach and includes the following modules: (1) psycho-education, (2)
relaxation therapy and mindfulness, (3) cognitive behavioural approaches and
(4) activating therapy.
The intervention, psychosomatic therapy, implies that patients* symptoms,
illness beliefs, anxiety, concerns, illness behaviour and social environment
are addressed. It is a tailor-made treatment for the symptoms and psychosomatic
therapy is captured in a treatment protocol which allows the therapists to
change the intensity, frequency and order of the four modules in order to
deliver a tailor-made approach, fitting within the recommendations of the
recent Cochrane review on non-pharmacological interventions of somatoform
disorders and MUS.
In the psychosomatic therapy sessions the therapist together with the patient
explores and treats somatic symptoms by integrating the physical, cognitive,
emotional, behavioural and social dimensions of the symptoms presented. During
the therapy underlying beliefs and psychosocial factors, which influence the
perceived somatic symptoms, are identified in order to give patients
(experienced) insight in the interaction of these factors with the somatic
symptoms. This will result in empowerment of the patients to regain control
over their own health.

Usual care / comparison:
Patients in the control group will receive usual care provided by the GP and
other health care professionals. The usual care for patients with MUS has been
described in the guideline on the management of MUS of the Dutch College of
General practitioners. It advocates GPs to focus on the exploration of the
symptoms, and related cognitions, emotions and behaviour, and apply
psychoeducation, monitoring, and when necessary refer for physical therapy,
mental health nurse-practitioners or cognitive behavioural therapy (CBG). GPs
don*t use these additional referral options very often as patients resist
*psychological* treatments for their physical symptoms.

Questionnaires will be administered at baseline, at 4 and 12 months. These
questionnaires consist in total of 166 items and will take patients
approximately one hour to complete.
The patients in the interventiongroup will get 6 to 12 sessions psychosomatic
therapy, each of 45 minutes, delivered by a specialized exercise or physical
therapist.