Chronic spinal pain (i.e., chronic neck pain and chronic low back pain) are highly prevalent, and are known for their immens personal and socio-economic burden. Chronic spinal pain is impacted by many aspects, and in this story, insomnia plays an important role. Clinical insomnia symptoms are very common in people suffering from chronic spinal pain, and the presence of insomnia is known to aggravate the chronic spinal pain symptoms. While research shows that tackling insomnia in these patients is helpful for these patients, the availability of cognitive behavioral therapy, the golden standard to treat insomnia, is unfortunately extremely limited. Therefore this study aims to investigate whether a stepped care approach to cognitive behavioral therapy is a solution to this problem.
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Parallel
Standard Care CBTi
BehavioralStandard Care CBTi will take 10 weeks, during which the participant will receive 5 online les-sons and 3 online face-to-face talks with the therapist. The construction of the online intervention was based on self-help materials, research of the literature, and patient interviews. It consists of 5 online les-sons and incorporates elements commonly used in face-to-face CBTi. The 5 online lessons, one introduced every second week, cover the following topics: Education, stimulus control, sleep restriction, relaxation, cognitions. The intervention is supported by online coaching, with feedback aimed at reviewing exercis-es, clarifying information, and motivating patients to continue the course and make necessary behavioral changes.
Stepped Care CBTi
BehavioralThe stepped care approach in CBTi entails a two-step approach. Participants in this group all receive an initial entry level session of 1 hour delivered by a trained physiotherapist. Step 1: The "entry level" in this stepped care approach will imply a single, 1-hour long session, administered by a physiotherapist. This single session will cover: 1) education on sleep, sleep pressure, circadian rhythms; 2) introducing entry-level CBT-i principles (e.g., optimizing sleep environment, pre-bedtime food and beverage consumption) 3) pinpointing 2 to 3 of the most relevant strategies for the participant; and 4) creating an action plan for consistent implementation of these strategies over the next month. One month after 'Step 1' the participants' score on the Insomnia Severity Index (T1) will guide further decision making. Those with ISI scores \<12 will enter the follow-up phase immediately. Those with ISI scores ≥12 after step 1 will be referred to standard care CBTi.
Rate of remission from insomnia
Rate of insomnia remission will be assessed using the Insomnia Severity Index (ISI), a self-report questionnaire assessing the nature, severity, and impact of insomnia. Participants will be considered treatment responders if their Insomnia Severity Index (ISI) score improves by ≥8 points and will be considered as having remitted if their post-treatment ISI score is \<12.
Insomnia Severity
Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI), a self-report questionnaire assessing the nature, severity, and impact of insomnia. Each item scored on a Likert scale ranging from 0 (no problem) to 4 (very severe problem) yields a total score, interpreted as: 0-7 = absence of insomnia; 8-14 = sub-threshold insomnia; 15-21 = moderate insomnia; and 22-28 = severe insomnia. The score will be used as a continuous variable in the analysis.
Medical Consumption Questionnaire
The Medical Consumption Questionnaire (MCQ) is an instrument for measuring medical consumption. The MCQ includes questions related to frequently occurring contacts with health care providers.
Productivity Cost Questionnaire
The Productivity Cost Questionnaire (PCQ) is a recall questionnaire that collects data related to loss of productivity in paid and unpaid work.
Health-related quality of life
The EQ-5D is a standardized instrument used to assess five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by assigning a score. From this, a weighted health index can be derived for an individual or a population.
Demographics
Information on age, sex, educational level, employment status, marital status, and ethnici-ty will be collected.
Adverse Events
With each online assessment (except for baseline), adverse events will we questioned in the participants. This will be done using the following question: "What unusual symptoms or medical problems have you experienced since the last round of questionnaires?". Re-ported adverse events will be classified as 'mild' (i.e., mild concentration problems), 'mod-erate' (e.g., fever) or 'serious adverse events' (e.g., death, hospitalization). No moderate or serious adverse events are expected in this trial.
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