JMIR Publications

ABSTRACT

Background:

Medically unexplained symptoms (MUS) constitute a major health problem because of their high prevalence, the suffering and disability they cause, and the associated medical costs. Internet-based interventions may provide an accessible and convenient tool for managing MUS. We developed a personalized, internet-based, guided self-help intervention for MUS in primary care (Grip) and will compare its effectiveness to that of usual care.

Objective:

To describe the rationale, objectives, and design, of a pragmatic randomized controlled trial assessing the effectiveness of Grip.

Methods:

For a pragmatic, multi-center randomized controlled trial, 165 adult patients with mild to moderate MUS will be recruited through general practices in the Netherlands. Randomization will be performed at general practice level. Patients in the intervention group will receive a personalized set of online self-help exercises, targeting the unhelpful cognitions, emotions, behaviors, and social factors that are relevant to them. The intervention is guided by a general practice mental health worker. The control group will receive care as usual. Primary outcome is physical health-related quality of life (RAND-36, physical component score). Secondary outcomes include severity of physical and psychological symptoms, mental health-related quality of life, cost-effectiveness, and acceptability. Assessments will take place at baseline, end of treatment, and at 16, 26, and 52 weeks follow-up.

Results:

Recruitment has started in December 2018.

Conclusions:

To our knowledge, this is the first study to combine the concepts of e-health, self-help, and personalized medicine in the treatment of MUS. By improving the quality of life and reducing symptoms of patients with MUS, Grip has the potential to reduce costs, and conserve scarce healthcare resources. Clinical Trial: Dutch Trial Register, identifier: NTR7598, registered on 8 November 2018.