RATIONALE
The two-way street of chronic spinal pain (CSP) and insomnia: a bidirectional
relationship
Chronic spinal pain (CSP) is a highly prevalent and pressing health concern, known
for its ex-tensive health and socioeconomic burden, incl. prolonged sick-leave,
reduced quality of life, and substantial socioeconomic costs. Also, CSP ranks as one
of the most prominent causes of years lived with disability worldwide. CSP is a
multifaceted problem, and is significantly influ-enced by various factors, among
which insomnia plays a pivotal role. Insomnia is, in the absence of other intrinsic
sleep disorders and shift work, defined as a sleep dissatisfaction associated with
difficulties initiating, maintaining or returning to sleep for >3 days/week for >3
months, with a clear impact on daytime functioning. Clinical insomnia symptoms are
very common in peo-ple with CSP, with prevalence rates ranging from 53% up to 90%.
Consequently, people with CSP experience detrimental daytime effects, such as memory
impairment, work-related issues, and reduced quality of life.
Insomnia is often considered a result of CSP, yet research findings suggest a
bidirectional relation-ship between both. Sleep problems can both trigger and
sustain pain, indicating a complex interplay where each can amplify the intensity of
the other. Thus, the presence of insomnia can hinder treatment effectiveness in CSP.
Moreover, insomnia is also associated with de-creased daily functioning and life
satisfaction in this population. Notable, people with chronic pain tend to engage in
increased physical activity after one night of better sleep. Hence, target-ing
sleep-related issues in people with CSP and comorbid insomnia by offering them an
appropri-ate treatment for insomnia (i.e. cognitive behavioral therapy) integrated
into pain management is found to enhance treatment effects.
Cognitive behavioral therapy for insomnia (CBT-i): Gold Standard Treatment
Cognitive behavioural therapy for insomnia (CBT-i) is the gold standard treatment
for treating insomnia. Over 200 systematic reviews and meta-analyses show evidence
for its high long-term, clinically meaningful effectiveness. CBT-i is
non-pharmacological and aims to rectify mala-daptive sleep-related beliefs and
behaviors, by targeting cognitive and behavioural factors that maintain insomnia
with a multicomponent approach, incl. sleep hygiene and restriction, stimulus
control, cognitive therapy, and relaxation training. International guidelines
recommend CBT-i as first-line treatment for insomnia, and its favorable impact
extends to people with chronic pain and comorbid insomnia. Notable, in the context
of CSP, an RCT evidences substantial enhancements (moderate to large and clinically
meaningful effect sizes) in sleep-related pa-rameters and the impact of pain on
daily function.
Extremely limited accessibility of CBT-i prevents people from benefiting its
efficacy
The compelling evidence outlined above underscores the importance of integrating
CBT-i within pain management. The challenge for CBT-i is no longer to prove its
credentials, but to punch its weight, as the extremely limited accessibility of
CBT-i hinders patients from both en-gaging in and benefiting from CBT-i. This
extremely limited accessibility results from the short-age of licenced CBT-i
practitioners, alongside a lack of comprehensive training among primary care
providers regarding the identification of sleep-related issues and the appropriate
referral for such complaints. Moreover, it is worth noting that the traditional and
current usual application of CBT-i necessitates a significant investment of the
patient's resources in terms of time, energy, and costs. While the efficacy of CBT-i
in people with CSP is undeniably established, it is imperative that future research
delves into strategies for mitigating these implementation barriers linked to
accessibility. A stepped care model enhances resource efficiency by strategically
allo-cating the most expensive human resources to situations where they are most
essential, and op-timizes the capacity to effectively treat a larger number of
individuals at lower levels of care.
Breaking down the barriers: A stepped care CBT-i approach as a promising solution
To mitigate these challenges of CBT-i access in people with CSP, a stepped care
approach offers a solution (fig. 2). This involves providing a step 1 ("entry
level") characterized by easy access, minimal therapeutic intensity, least
inconvenience for patients, cost-effective, and requir-ing minimal specialist time.
An evidence-based approach meeting these criteria, involves replacing
sleep-interfering behaviors with sleep-promoting ones through education and behavior
change councelling, which can aid sleep initiation and maintenance. Essentially, as
step 1 is suitable for dissemination by non-specialists such as nurses, doctors, and
physiotherapists, it becomes more accessible for people dealing with insomnia.
Moreover, its lower required commit-ment facilitates engagement. The stepped care
approach implies that not benefiting sufficiently from the initial "entry level"
gives access to step 2: comprehensive, highly effective standard CBT-i.
Proof of concept for Stepped Care CBT-i in Chronic Conditions: Transforming
Treatment Paradigms
Due to its efficacy, clinical impact, cost-effectiveness and feasibility for many
psychological inter-ventions, the stepped care approach is put forward by experts as a
promising strategy, which can increase access to high quality interventions. Specifically
for insomniacs, uncontrolled studies suggest the effectiveness of stepped care CBT-i with
a 69% improvement in sleep efficien-cy. In the context of chronic conditions, an
uncontrolled trial (n=51) demonstrated a 45% response (with 41% remitted) to a single
session of sleep-related education and behavioral counceling, and subsequent standard
CBT-i for the unremitted participants resulted in a 79% response rate and 71% remission.
Together with an uncontrolled non-inferiority RCT (n=177) which further corrobo-rated the
effectiveness of stepped care CBT-i, this evidence positions stepped care CBT-i as a
val-uable and accessible alternative to standard interventions. Looking ahead, the focus
of the StepUp project, aligns seamlessly with prevailing expert recommendations. While
stepped care CBT-i in CSP awaits empirical validation, a qualitative study in clinicians
(n=42) and patients (n=10) supports the feasibility of implementing stepped care in
clinical practice. Yet, despite recom-mendations and the prevalence and impact of
insomnia in CSP, high-quality controlled trials exploring stepped care CBT-i in this
population remain lacking. In summary, these compelling findings not only show the
potential benefits of stepped care CBT-i, but also underscore the urgent need to extend
this transformative paradigm to the CSP population, as high-quality evidence is lacking.
STUDY OBJECTIVES
In light of the aforementioned considerations, the primary research objective is to
examine whether stepped care CBT-i, in comparison to standard CBT-i and a usual care
group, leads to a high-er rate of remission from insomnia among people with CSP at 6
months post-treatment (i.e. Pri-mary Endpoint).
Secondary objectives are to assess if stepped care CBT-i, relative to standard CBT-i and
a usual care group, yields:
Improved cost-effectiveness: Analysing the economic implications and efficiency of
stepped-care CBT-i compared to the alternatives.
Reduced pain-related and/or sleep-related medication use: Investigating the impact
on medica-tion as a key of treatment efficacy.
Higher treatment adherence at treatment completion: assessing the levels of patient
adher-ence throughout the treatment course
A final secondary aim is to evaluate whether stepped care CBT-i surpasses the usual care
group in enhancing sleep quality, pain and physical function among people with CSP.
The overarching hypothesis is that stepped care CBT-i equals or surpasses standard care
CBT-i in remission efficacy, with added benefits like reduced medication use, and
improved adherence and cost-effectiveness. Additionally, stepped care CBT-i is expected
to surpass the usual group in improving sleep quality.
STUDY DESIGN
To examine the research aims, a three-arm RCT in people with CSP will be used to compare
stepped care CBT-i, standard CBT-i, and a usual care group. Outcome assessments will take
place at baseline, 1 month (T1 = during the intervention period), 3 months (T2 = directly
post-treatment), and 9 months (T3 = 6 months follow-up). T1 is the time point where
participants in the stepped care group who have not remitted after the entry level (step
- treatment will continue with receiving comprehensive CBT-I (step 2). T2 is the
immediate post-treatment assessments after comprehen-sive CBT-i (both for stepped care
CBT-i and the standard CBT-i groups). 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 posttreatment ISI score is <12. Participants
ran-domized to the stepped care CBT-i group whose ISI remained ≥12 after step 1 will be
referred to step 2.
