Retraining the Fatigued Brain (REFAB): A randomized controlled trial evaluating personalized cognitive rehabilitation treatment in somatic symptom and related disorders

Somatic symptom and related disorders (SSRD) are disorders that involve
significant distress due to and impairment caused by (anticipated) physical
complaints. These disorders are often accompanied by cognitive complaints which
to date are not treated with targeted evidence-based therapy.

In the current study, the subjective and objective effectiveness of cognitive
rehabilitation therapy for people with somatic symptom and related disorders
will be investigated. Additionally, the effects of this treatment on brain
activity in the frontal cortex, the neuroendocrine system, the autonomic
nervous system and the immune response will be researched.

Randomized controlled trial

The experimental group will receive personalized cognitive rehabilitation
treatment, whereas the control condition will receive treatment as usual
(cognitive behavioral therapy).

The risks of participation are minimal. Both experimental and control
treatments are already given in the target population, and the experimental
treatment has already been proven to be effective in other patient populations.
The burden associated with participation includes taking part in a non-invasive
psychophysiological assessment (i.e., fNIRS, cortisol and heart rate
variability measurements), once before and once after the treatment. In
addition, participants are asked to fill in additional questionnaires pre and
post treatment, as well as at six months follow up. In case patients take part
in the experimental condition, they are able to receive treatment tailored to
their cognitive complaints. In addition, patients in this condition still have
the possibility to receive the treatment as usual upon completion of the study.