Sleep as an additional painkiller

Chronic pain is a pervasive experience that significantly impacts daytime
functioning and disrupts sleep. Sleeplessness (insomnia) exacerbates patients*
chronic pain and diminishes overall well-being and functioning. Moreover, the
interplay between chronic pain and insomnia can escalate into a vicious cycle,
hindering pain treatments' effectiveness, increasing the risk of a new pain
problem after successful treatment, and therefore unnecessarily prolonging
patient suffering as well as increases costs of pain healthcare.
The hypothesis of this study is that enhancing standard pain treatment by
adding an internet-based, guided Cognitive Behavioural Therapy for Insomnia
(i-CBT-I) at the start of pain treatment may alleviate patient suffering and
reduce healthcare costs associated with pain healthcare.

The objective of the study is to investigate whether adding i-CBT-I at the
start of standard pain treatment can enhance pain healthcare by reducing
patient suffering and costs compared to Treatment As Usual (TAU). Our analyses
will examine whether patient characteristics (such as having comorbid mental
health problems) influence this effect. Additionally, we seek to evaluate
whether providing a brief neuroscience educational film prior to i-CBT-I
explaining the vicious cycle between sleep and pain improves the effectiveness
and implementation of i-CBT-I. Lastly, we aim to identify factors that
facilitate or hinder i-CBT-I implementation in the daily practice of a Pain
Medicine outpatient clinic.

The study is a monocentric, pragmatic, randomised controlled trial, enrolling
182 patients. Patients will be randomised on a 1:1:1 basis to receive either
i-CBT-I, i-CBT-I preceded by a brief neuroscientific educational film
(i-CBT-I+) or TAU. Assessments will be conducted at baseline, upon completion
the i-CBT-I or control condition and six months after completion of the i-CBT-I
or control condition.

The i-CBT-I utilised in our study, referred to as i-Sleep, consists of six
weekly online sessions covering the following topics: sleep psychoeducation,
sleep hygiene, sleep habits/lifestyle, sleep rhythm, cognitive strategies and
relaxation. To customize i-Sleep while minimizing costs, therapists and
patients communicate via text messages within the i-Sleep application.

Participating in the study entails completing assessments and, if randomised to
i-CBT-I, adhering to the treatment, both of which require time and energy from
patients. To minimize nocturnal discomfort, we utilise a sleep monitoring
system positioned under the mattress rather than physically attached to the
patient, ensuring minimal disruption to sleep and adherence to the research
protocol.

Patients undergoing i-CBT-I may experience a reduction in insomnia, potentially
improving physiological, psychological, and social well-being and functioning.
However, i-CBT-I may also lead to temporary side effects, including sleep
disturbances, fatigue, daytime sleepiness, loss of motivation/energy, and
headaches. Patients will be informed in advance about these potential side
effects.