Reducing Worry in Patients with Medically Unexplained Symptoms: A Feasibility Study

Somatic complaints (SC), such as headaches, gastrointestinal problems, fatigue
and back pain, are the second most reported health problems in primary
healthcare in the Netherlands. One in five patients presenting with such SCs in
primary care, has Medically Unexplained Symptoms (MUS). MUS are symptoms
without a clear medical, organic cause. MUS are often vague, consequently,
medical professionals cannot adequately help people presenting with these
symptoms, which often results in unnecessary, unproductive referrals and
medical procedures. Consequently, MUS are not only responsible for high health
care costs, but also for economical costs in the form of a loss of productivity
on the work floor and high sick leave compensations. Moreover, MUS are
responsible for high humanitarian costs, as evidenced by research indicating
that higher levels of subjective SCs are related to a poor health-related
quality of life.
Former research has established a link between worry and SCs. Following the
definition of Borkovec et al., worry is a *chain of thoughts and images,
negatively affect-laden and relatively uncontrollable; it represents an attempt
to engage in mental problem-solving on an issue whose future outcome is
uncertain but contains the possibility of one or more negative outcomes;
consequently, worry is related closely to fear processing.* Worrying has been
associated, amongst others, with SCs like the one*s mentioned above: fatigue,
lower back pain and other pains, but also to cardiovascular disease and in
general to heightened activation in the endocrinological, cardiovascular,
neurovisceral and immune system. Moreover, worry has been pointed to as a
central factor in multiple psychopathologies, such as Generalized Anxiety
Disorder and Posttraumatic Stress Disorder. However, the link between worry and
SCs does not only occur in high-level worrying; negative health consequences
already occur in low-level worrying. Furthermore, the relationship between
worry and negative health consequences is also described in the MUS-literature;
worry is described as a precipitating factor for physical symptoms in cognitive
behavioral-models of MUS.
The link between worry and SCs informed a study by Brosschot and van der Doef
in which a worry reduction intervention (WRI) was tested in adolescents. In
this intervention, participants in the intervention group were instructed to
postpone their worries to a self-chosen, 30-minute *worry-window* in the late
evening. The intervention group got the following instruction: *If you find
yourself worrying, try to stop and postpone it to your 30-minute worry-window
at night.*, whilst the control group only had to register their worries.
Results showed that the intervention group reported significantly less SCs and
a reduction in worry duration. Brosschot and van der Doef have replicated these
promising results in a child-sample in which the instructions were adapted for
this younger age group. These studies have focused on SCs, however, given the
fact that worry is also described as a precipitating factor for MUS in
CBT-models of MUS, we believe that manipulating worry duration with the use of
the WRI, might also prove to be effective among MUS-patients.
CBT is the current intervention of choice for MUS, however, improvements of
SCs are modest and MUS-patients are known to be resistant to psychological
treatment, because they feel their health complaints are being categorized as
*in their heads*. Furthermore, CBT is effective only when delivered by
psychotherapists, which is therefore non-accessible for GPs. Other treatments
and interventions that can be delivered by GPs in primary care have limited
effectivity. For example, reattribution, a structured patient-focused approach
for patient education on SCs, does not show consistent effects. Therefore,
there is a need for acceptable interventions that can be delivered in primary
care.

The primary goal of this study is to assess the feasibility and acceptability
of the worry reduction intervention among MUS-patients and GPs as implemented
in primary care.
A second important goal of this study is to assess the feasibility of carrying
out a randomized controlled trial in the future which will assess the
(cost)efficacy of the worry reduction intervention among MUS-patients.
Specifically, the objective is to assess the feasibility of the trial
procedures, including the recruitment of GPs and MUS-patients, the
appropriateness of the measures, and percentage of patient withdrawal during
the study.

This study entails a feasibility study among MUS-patients in primary care.
Participating MUS-patients will be randomized to either the intervention group
(care as usual by GP + WRI) or to the control group (care as usual by GP). The
WRI will be implemented in primary care and the study period will last six
days.
The choice for a feasibility study was based on the fact that an intervention
of this sort has not yet been tested in a primary care patient-setting before
and among MUS-patients. A feasibility study is the preferred study design in
preparation of future, larger randomized controlled designs, because of its
ability to address the acceptability and feasibility of an intervention and of
the study procedures. Qualitative aspects are added regularly to understand the
perspective of health professionals and patients more thoroughly. These aspects
can help to improve the intervention and study procedures, in order to prepare
it for a larger-scale randomized controlled trial.

Participants will be asked to immediately terminate their worries during the
day, if they realize they are worrying. They are further asked to postpone
these worries to a self-chosen 30-minute time period at night, later to be
called their *worry-window*. Participants will receive the following
instruction: *Every time you find yourself worrying during the day, try to stop
and postpone these worries to a self-chosen 30-minute time period at night. If
you do not succeed right away, please try again.*
The instruction to postpone worries is a key component of Cognitive Behavioural
Therapy (CBT) for Generalized Anxiety Disorder (GAD), which is called stimulus
control. However, this instruction is modified for our goals, with a big
difference lying in the fact that participants here will not receive an
instruction on the timing and the content of their worry-window. The selection
(and modification) of this component was made by Brosschot and van der Doef,
because of its success in reducing and controlling worry.

Patients in the control group will be expected to fill in questionnaires daily
for the study period (6 days) for approximately 15 minutes per day and patients
in the intervention group will additionally be expected to practice for half an
hour each day during the 6-day study period. Patients can practice in their
usual environments.