WorRI in MUS

Rationale: One in five people presenting with somatic complaints in primary care, has Medically Unexplained Symptoms (MUS). General Practitioners (GPs) cannot adequately help these people due to the vague nature of these symptoms, which often leads to unnecessary referrals and unproductive medical procedures. Therefore, MUS are responsible for high healthcare costs. Currently, Cognitive Behavioural Therapy (CBT) is the treatment of choice for MUS, however, improvements are modest and MUS-patients are known to be resistant to psychological treatment. Therefore, there is a need for acceptable interventions.
Objective: To study the feasibility and acceptability of a simple Worry Reduction Intervention (WRI) and of study procedures to set up a larger trial among MUS-patients in primary care.


Study design: A feasibility study in which MUS-patients will all be randomized to either the intervention group (care as usual by GP + WRI) or the control group (care as usual by GP).
Study population: MUS-patients will be recruited by GPs. Four GPs will each identify four MUS-patients (aged 18-80 year). These MUS-patients will be invited to participate.


Intervention: The intervention consists of an instruction to postpone worries during the day to a 30-minute ‘worry-window’ in the late evening, in which patients are allowed to worry. The WRI will last six days and patients are able to do the WRI in their usual environments.


Main study parameters/endpoints: Our primary outcome measure is the feasibility and acceptability of the WRI, measured primarily with in-depth interviews for which four GPs and approximately ten MUS-patients will be invited to talk about their experiences with the intervention. Additionally, patient satisfaction with the intervention, measured with a Likertscale, percentage of patient withdrawal and perceived symptom severity, measured with a VAS, will be assessed.

Primary Objective: 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.



Secondary Objective(s): 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.



There are no specified hypotheses because of the exploratory nature of this feasibility-study.

T1: pre-measure (within 1-2 weeks after entrance clinic)

T2: post-measure (after 6 days of intervention/control and experience sampling)

T3: interview (within 1-2 weeks after ending intervention)

Worry Reduction Intervention (WRI):

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 selfchosen 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.’ Participants will be advised not to plan their worry window within an hour before bedtime.

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 intervention group will receive the WRI in addition to the usual care they receive of their GP. Patients in the control group will only receive care as usual by their GP.
This group will be offered the WRI after this period.