https://orcid.org/0000-0002-4421-388X
Figures
Abstract
Background
Disordered sleep and persistent musculoskeletal pain are highly comorbid. Behavioural interventions such as Cognitive Behavioural Therapy for Insomnia (CBT-I) have shown promise in the management of both disordered sleep and persistent musculoskeletal pain. The aim of this review was to examine how CBT-I is delivered in randomised controlled trials involving people with comorbid disordered sleep and persistent musculoskeletal pain.
Methods
The protocol for this scoping review was registered with the Open Science Framework. Electronic searches of ten database and three clinical trials registries were performed up to 25 October 2023. The methodological quality of each study was evaluated by two independent reviewers using the PEDro tool. The reporting of CBT-I interventions was evaluated using the Template for Intervention Description and Replication (TIDieR) checklist.
Results
Twelve studies met the eligibility criteria. TIDieR scores ranged from 7-11/12, with a mean score of 8.8/12. CBT-I always involved two core components–sleep restriction and stimulus control. Furthermore, an additional five components were usually involved–a cognitive component, sleep hygiene, sleep education, relaxation/deactivation procedures and relapse planning. There was also considerable consistency in the frequency (weekly) and duration (5–9 weeks) of CBT-I programmes. Aspects inconsistently reported included who delivered the intervention; what modifications were made, if any; and the session content and duration. PEDro scores ranged from 5-8/10, with a mean score of 6.7/10.
Conclusions
These findings demonstrate considerable consistency in the components of CBT-I delivered in clinical trials along with the number of sessions. The frequency of sessions was also consistent where almost all studies held weekly session. However, some aspects were either not reported (e.g., precise content of components) or inconsistent (e.g., use of terminology). CBT-I was delivered both individually and in groups. Greater consistency, and more detailed reporting regarding who delivered the intervention, the training provided, and the specific content of CBT-I components would add clarity, and may enhance CBT-I efficacy and allow better replication.
Citation: Browne A, Cahalan R, O’ Sullivan K (2024) How is cognitive behavioural therapy for insomnia delivered to adults with comorbid persistent musculoskeletal pain and disordered sleep? A scoping review. PLoS ONE 19(7): e0305931. https://doi.org/10.1371/journal.pone.0305931
Editor: Sascha Köpke, University Hospital Cologne: Uniklinik Koln, GERMANY
Received: September 2, 2022; Accepted: June 6, 2024; Published: July 18, 2024
Copyright: © 2024 Browne et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the manuscript and its Supporting Information files. This submission contains all raw data required to replicate the results of this study.
Funding: One author (AB) is the recipient of a Fee Waiver from the Faculty of Education and Health Sciences at the University of Limerick. The authors have been awarded the BMP Patient Centred Innovation Grant for a follow up study. There is no grant number applicable. The funders did not play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Persistent musculoskeletal (MSK) pain (e.g. low back pain, arthritis) is one of the biggest burdens on healthcare delivery worldwide and a major cause of years lived with health-related disability internationally [1]. Persistent pain is defined as pain that persists for longer than three to six months and is estimated to affect 20% of the world’s population [2]. Insomnia is reported in over half of people with persistent MSK pain [3–5] Disordered sleep and persistent MSK pain have reciprocal effects on one another, and comorbid disordered sleep is recognised as an important issue for clinicians [6, 7]. However, despite emerging evidence of efficacy [8], evidence-based sleep interventions, such as cognitive behavioural therapy for insomnia (CBT-I), are rarely implemented in the clinical management of persistent MSK pain [9], even when disordered sleep is present. Instead, a range of interventions which are more costly, risky and/or less effective (e.g. opioids, surgery, imaging) continue to be offered [10, 11]. A number of guidelines recommend the use of exercise, pacing and other strategies for pain, but none explicitly recommend sleep as a treatment target [12–15].
In recent years psychologically informed rehabilitation approaches have been promoted in the treatment of persistent MSK pain, especially when other comorbid factors (e.g. poor sleep, anxiety, depression) are present [10, 16, 17]. CBT-I appears to be effective for the treatment of both sleep [18] and MSK pain [7] and is more effective for disordered sleep than other non-pharmacological approaches such as sleep hygiene advice [18]. CBT-I is a multi-component treatment for insomnia [19]. Common core components include sleep restriction, sleep hygiene, stimulus control and cognitive therapy [19]. Due to the non-pharmacological nature of CBT-I, it is not associated with the addiction issues surrounding many pharmacological approaches [20]. However, issues such as the training required to deliver CBT-I, and concerns about scope of practice, could limit its uptake and utilisation by clinicians.
Furthermore, while CBT-I is recognised as a first line treatment for insomnia [21], it appears there is considerable variation in how it is delivered across studies [7]. For example, the format could be face to face, online or telephone sessions, and in a group or one-to-one format [22]. The precise content of CBT-I in randomised controlled trials (RCT) appears to vary, including in components such as sleep education, sleep hygiene, relaxation, sleep restriction and cognitive restructuring. Clinicians routinely involved in treating MSK pain (e.g., physiotherapists) have developed skills in psychologically informed care in recent decades [23–25]. However, it is not clear which professionals are involved in the delivery of CBT-I within clinical trials, or how they are trained and supervised.
To better understand how to implement CBT-I for comorbid persistent MSK pain and disordered sleep, a critical evaluation of the delivery of CBT-I in clinical trials is required. Lack of access to psychologists and social workers is a known barrier to implementation of psychologically informed care [9]. This scoping review will inform whether there is potential for first contact practitioners such as physiotherapists, nurses and general practitioners dealing with persistent MSK pain patients, to provide CBT-I. Therefore, this scoping review will explore the delivery of CBT-I in people with comorbid persistent MSK pain and disordered sleep. Specifically, the review will address the following questions:
- What is the content (e.g., components) of CBT-I delivered to patients with comorbid disordered sleep and persistent musculoskeletal pain in RCTs?
- What is the format (e.g., delivery mode and personnel, frequency, duration) of CBT-I delivered to patients with comorbid disordered sleep and persistent musculoskeletal pain in RCTs?
Methods
This scoping review was conducted according to Peters et al. (2020) [26] methodology for scoping reviews. There are six steps including: 1) defining the research question/s, 2) identifying relevant studies, 3) study selection, 4) charting the data, 5) collating, summarising, and reporting the results, and 6) consultation. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed using the PRISMA extension for scoping reviews (PRISMA-ScR) checklist [27]. An iterative approach was taken towards searching the literature, refining the search strategy, reviewing articles for inclusion, and extracting relevant data.
Protocol and registration
The scoping review protocol was registered with the Open Science Framework on 02 July 2021. Available at https://osf.io/dvja8/.
Eligibility criteria
We focused on CBT-I delivered as stand-alone CBT-I or as hybrid CBT-I which included components of CBT-I and CBT- P (Cognitive Behavioural Therapy for Pain) such as CBT-IP or CBT-PI or CBT-C. Due to the high volume of studies available on the topic, and the likelihood of better reporting standards in such studies, we focussed on RCTs exploring CBT-I programmes. No restrictions were placed on the location where care was delivered (e.g., public or private setting or community), the healthcare professional delivering the care, whether it was applied in a group or individual setting, or whether it was delivered in-person or using a telehealth platform.
Inclusion criteria
- Studies of adults 18 years and older
- Studies where all participants reported both comorbid persistent MSK pain (e.g., spinal pain, arthritis, headache) and disordered sleep
- Completed RCTs, excluding those designated as ‘pilot’ studies.
- Published in English, or with an English translation
Exclusion criteria
- Studies that explicitly included participants with acute pain only (e.g., all participants had pain for <3 months)
- Studies that explicitly included participants with a diagnosis of sleep disorders such as sleep apnoea, narcolepsy, restless leg syndrome and parasomnias
- Studies of people with conditions which could clearly cause pain that is not primarily MSK in nature (e.g., cancer, multiple sclerosis etc)
- Studies of only experimental pain
- RCTs which were only published as protocol or design papers
- Secondary analyses of RCTs, where the same data was already published and shortlisted
Information sources/ search strategy
A comprehensive search strategy was developed with a research librarian. We applied this search strategy to the following nine databases; Medline, EMBASE, CINAHL Complete, PubMed, Academic Search Complete, AMED, APA PsychArticles, APA PsychInfo and SPORTDiscus with Full Text. RCTs from 1996 to 19 August 2021 were initially searched, with a ‘bridge’ search conducted in February 2022 and October 2023. Reference lists of selected articles, meta-analysis and Cochrane reviews were searched for additional studies. Searches were undertaken to find completed studies for registered study protocols and authors of relevant registered study protocols shortlisted were contacted to identify additional studies in print. Grey literature (Open Grey database) and three clinical trial registries (Cochrane Central Register of Controlled Trials (CENTRAL), Clinical Trials Registry (https://clinicaltrials.gov) and Australia and New Zealand Clinical Trials Registry (https://www.anzctr.org.au) were also searched.
Evidence screen and selection
Removing duplicates of articles was conducted using Rayyan online software [28] https://www.rayyan.ai. Initially, two reviewers selected a sample of eligible titles and abstracts and assessed for suitability. After confirming very good agreement and in line with the AMSTAR checklist (at least 80 percent), the remainder were screened by one reviewer only https://amstar.ca/Amstar_Checklist.php. Where there was insufficient data provided in the title and abstract, the full text was retrieved and analysed to determine eligibility. This process was represented using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach [29].
Data charting process
Extraction tables were initially piloted with two team members of the team on two articles. Charting was iterative and the form was updated with continuous data extraction.
Study characteristics
The following data were extracted from each study: Country, Participant Age (mean where available), Sample size, Gender, Type of CBT, Treatment comparison, MSK Condition, and Sleep Criteria.
Description of CBT-I intervention
The 12 item TIDieR checklist was developed to improve reporting of complex interventions in clinical trials [30]. Items that have no description or are poorly described do not meet the criteria for this item [30]. All data relevant to the TIDieR Checklist were extracted for each study. We have used a TIDieR checklist scoring system developed in a previous study [31] to report if the criteria for each item in the TIDieR Checklist was achieved. For each item, a score of 0 was given if the checklist item was not achieved or partly achieved, a score of 1 was given if the if the checklist item was fully achieved, such that the maximum score was 12. A low scoring study indicated insufficient detail of the intervention was provided and a high scoring study indicated that sufficient detail of the intervention was provided. Each of the studies that did not provide a reference for their treatment manual was emailed asking for a copy of the treatment manual used in their study.
Critical appraisal of individual sources of evidence
While not considered mandatory in scoping reviews, we felt it was important to critically appraise individual sources of evidence. The Physiotherapy Evidence Base Database (PEDro) is an 11-point scale appraising the methodological quality of RCTs, assessing issues related to bias and quality of reporting [32]. If a PEDro score was already provided on their database (https://pedro.org.au), we used that score. For all other studies, two independent authors assessed the risk of bias and quality of reporting for all studies, and any disagreements were resolved by asking a third author. A score of 1 was given if the study fully achieved the criteria. Total PEDro scores have been interpreted as “fair” (4–5), ‘good’ (6–8) or excellent (9–10) [33].
Results
Initially, 417 studies were identified from databases (n = 277) and registers (n = 140), while a further 31 studies were found by searching citations and the Open Grey database (see S1 Fig). After removal of duplicates and ineligible studies, a total of 12 studies were eligible for inclusion (see S2 Fig). Key items reported in this review can be located in the PRISMA ScR Checklist (see S3 Fig).
Study characteristics
The characteristics across the studies are presented in Table 1. Study sample sizes ranged from 28 to 367, with a total of 1316 participants (82.4% female). The mean participant age ranged from 45.0 to 73.1 years. Overall, CBT-I was compared to five active interventions across nine studies (four studies compared CBT-I to cognitive behavioural therapy for pain (CBT-P), two compared to education only, two compared to sleep hygiene, one compared to behavioural desensitisation and one compared to applied relaxation), as well as being compared to usual medical care in three studies, a waiting list control in two studies and a ‘contact control’ condition in one study. CBT-I was delivered either alone (nine studies) or in combination with CBT-P (three studies).
Definitions of sleep disorders and pain
Sleep disorders were defined in five different ways (sleep symptom characteristics in five studies, DSM-IV-TR and Insomnia Severity Index in two studies, and DSM-III, DSM-IV and DSM–V in one study each). Five different MSK conditions were included (Fibromyalgia (FM) in five studies, OA in three studies, chronic pain in two studies and rheumatoid arthritis and spinal pain in one study each). Two definitions for FM were used across the five FM studies, with four studies using the American College of Rheumatology (ACR) criteria [43] and the remaining study using the ACR guidelines (pain for six months along with positive tender point testing). Definitions for OA varied in three ways (three-year diagnosis of OA prior to screening in one study, ACR diagnosis for OA knee in one study [44] and grade II, III or IV pain on the graded chronic pain scale in one study).
Reporting
TIDieR.
TIDieR scores ranged from 7-11/12, with a mean of 8.8/12 (see Table 2). All studies met the criteria for items 1, 2, 3, 4, and 6, such that the content (what materials, what procedures) and aspects of the format (when) were well described. Consistently low-scoring items of the TIDieR checklist were items 5 (who provided the intervention) where four studies met the criteria [7, 36, 39, 41], item 12 (intervention delivered as planned) where three studies met the criteria [7, 39, 40] and item 10 (modifications made), where no study met the criteria. The data from individual sources of evidence are charted in the TIDieR Checklist (see Table 3).
PEDro.
PEDro scores were available on the database for four studies [7, 18, 34, 45], and were calculated for the remaining eight studies [10, 35–40, 42] (see Table 4). PEDro scores ranged from 5-8/10, with a mean of 6.7/10. Ten studies were deemed good quality, with two deemed fair quality [34, 42]. All 12 studies met the criteria for random allocation, between group comparison and reporting both point estimates and variability. Ten studies had baseline comparability [7, 10, 18, 34–37, 39–41] and analysed data using intention to treat principles [7, 10, 34–36, 38–42]. As is typical of interventions such as CBT-I, no study had blinded clinicians delivering the intervention, but two studies report blinded participants [7, 41]. Eight studies had blinded assessors [7, 10, 18, 37–41]. Six studies documented concealed allocation [10, 37–39, 42, 46].
CBT-I content.
Table 5 illustrates the specific components of CBT-I identified by each study. Two components—sleep restriction and stimulus control—were included in all 12 studies. No details were provided across the studies to indicate adherence to sleep restriction. Four other components were usually involved in trials of CBT-I. Eleven studies included a cognitive component, with one study excluding it to try to keep the intervention as brief as possible [42]. Ten studies included sleep hygiene [7, 10, 18, 34, 36–41] and nine studies included sleep education [7, 10, 18, 34, 35, 37–39, 41], and relaxation or psychological/physiological deactivation procedures [7, 10, 18, 34, 37–39, 41, 42]. Eight studies Included relapse planning [7, 10, 18, 36–39, 42].
All studies provided physical or information materials to the participants or the interventionists. There was variation in what materials were used. Two studies provided detailed treatment manuals and referenced where to access them [36, 40]. Three studies state they provided written information, but failed to describe the depth of content and a reference to where to locate this information [7, 34, 38]. The remaining six studies stated they provide a detailed therapy manual but failed to reference where to access them [10, 18, 35, 37, 39, 41]. One study described providing standardised care, but does not describe using a manual [42]. Each of the ten studies that failed to provide a reference for the treatment manual were sent an email. At the time of publication, one author provided a copy of their treatment manual [7]. Three studies failed to describe where the intervention was delivered [34–36], however there was very little detail provided across the remaining studies on this item. No studies describe the process of content design nor did any study describe using public and patient involvement.
Component content variation.
Variation was found in the content of each component of CBT-I. Most studies provided detail on the content of each component, however some studies provided limited or no detail [10, 18, 37, 38, 41, 42]. This impacted on our ability to fully map the content of CBT-I. Monitoring and adjusting time in bed (TIB) was a frequently adapted strategy within Sleep Restriction, but there was much variation in prescription of same (see Table 6). Similarly, four studies provided no detail on what content was delivered on stimulus control [10, 18, 38, 41] and one study stated that they “reinforced the relationship between sleep and bed” without any further details [37]. Of the remaining studies, there was much agreement on the advice provided, but considerable variation on some aspects, such as avoiding napping (see Table 7).
There is variation in what form of cognitive therapy was delivered, and what this was called, and one study chose not to include this component to keep their intervention brief [42]. Interestingly, one study stated they included cognitive therapy but delivered some content within this component that other authors described under sleep education [35]. Due to lack of detail on the content of this study’s cognitive component’s, it is unclear if other cognitive restructuring content was delivered. Constructive worry and mindfulness was a frequently adopted technique but there was much variation in the prescription of same (see Table 8). Similarly, the definition of cognition and other factors such as sleep hygiene varied considerably between trials with implications for the associated treatment strategies.
CBT-I format.
Table 9 describes the specific format of CBT-I in each study. All studies delivered CBT-I interventions over five to nine weeks. Ten of the 12 studies described weekly sessions, one study provided six sessions over eight weeks [7] and one study failed to include this detail [40]. Limited detail was provided across the studies about where the intervention was delivered. One study stated CBT-I was delivered remotely via telephone consultations [7] and another delivered content online but failed to detail if this was pre-recorded content or delivered live [42]. It is uncertain if the remaining ten interventions were carried out face to face, but we assumed that they were. Of the eight studies who stated, six studies had group sessions [10, 18, 34, 37, 38, 41]. Group sizes ranged from 5–12 participants, although the most recent study failed to describe the group size [38]. Of the six studies using group interventions, three studies delivered combined CBT-I and CBT-P [10, 37, 41] and three studies delivered CBT-I alone [18, 34, 38]. All combined CBT-I and CBT-P interventions were carried out in groups of either 5–7 or 5–12 [10, 37, 41]. The length of time of each session varied from 15–90 minutes for individual sessions and 90–120 minutes for group sessions. One study failed to record the session length [42].
The professional background of those delivering the intervention was usually stated. CBT-I was carried out by Clinical Psychologists in three studies [7, 35, 41], pre/post-doctoral students in clinical psychology in three studies [34, 39, 40], therapists in two studies [18, 37], masters/PhD trained nurses in three studies [7, 36, 38], post-doctoral psychology fellows/faculty in clinical psychology in one study [40], post-doctoral researchers in clinical psychology in one study [10], masters students in psychology or senior psychologists in one study [42] social workers in one study [7] and family counsellors in one study [41]. Most studies provided no detail on the specific expertise in CBT-I, or the training undertaken to deliver CBT-I.
Discussion
Summary of evidence
This review aimed to map the content and format of CBT-I in RCTs in patients with comorbid disordered sleep and persistent musculoskeletal pain. The findings of this review would suggest there was considerable consistency in the components of CBT-I delivered in clinical trials along with certain aspects of delivery (e.g. frequency and number of sessions). However, some aspects were either not reported (e.g., content of components) or not consistent (e.g., use of terminology). Lack of detail provided across the studies impacted the ability to chart and compare the interventions between RCTs.
Content
This review found there was considerable consistency in two core components of CBT-I delivered across the included studies; sleep restriction and stimulus control. These findings are consistent with the core components used in other programmes assessing night time sleep disturbance and day time functioning in people with chronic insomnia [47] and sleep quality, daytime functioning, quality of life and fatigue in people with cancer [48]. Although, a cognitive component is typically also included in these studies.
Morin et al, 2006 describe CBT-I as any combination of the behavioral (e.g., stimulus control, sleep restriction, relaxation) and cognitive procedures [49] and this aligns, for the most part, with the findings of our study but it also describes a key feature of CBT-I. The flexibility to choose which components to deliver to the target cohort may be what is reflected here in the variation in additional components delivered alongside the core components. Some evidence suggest additional components might include a cognitive component [49], sleep hygiene [50], relaxation techniques [51] or sleep education [52]. Perhaps in patients with comorbid disordered sleep and persistent pain, the choice of relaxation techniques would be the additional component of choice as it has the benefit of decreasing arousal and stress, both of which are keys factors in managing persistent pain [53].
Limited detail provided on the content delivered in each component mirrors other studies which report similar issues with poor reporting of content of CBT-I components [54]. As a result we do not really know the precise content delivered in each component and there may be considerable variation. When detail was provided there was an abundance of information [36, 40] and usually involved referencing detailed treatment manuals, findings supported by other studies [55].
Persistent pain and insomnia are two of the most common complaints seen in General Practice and primary care [53, 56] yet demand for professionals trained to deliver CBT-I exceeds supply [53]. With appropriate training, this is an approach that can be adopted by a range of professionals. This review found that many different professionals delivered CBT-I, but limited detail was provided on what training was undertaken. Many of the skills required to deliver CBT-I are already inherent in the training and work of many professionals including General Practitioners, nurses and physiotherapists [57]. These professionals are progressively delivering psychologically informed treatments [57–59] and are more accessible professionals to this patient group than clinical psychologists who were most often used in the RCTs included in this review.
Taking into consideration the findings of recent studies, training might come in the form of an in-depth workshop and would benefit from including some experiential learning such as supervision [55, 57, 58]. The review found CBT-I was delivered by a number of professions with variable experience and specific CBT-I training. While it may be easier to achieve confidence in applying stimulus control and sleep restriction, there may be a perceived barrier to delivering a cognitive component. Front line therapists deliver elements of cognitive restructuring in relation to pain e.g. advice on catastrophising and pacing, but there may be a hesitancy when content is applied to sleep [57]. A study where GP’s and nurses delivered CBT-I to chronic insomnia patients found the practitioners felt the need for more extensive training having received two sessions of two hours duration [59]. The need for more training [59] and clinical supervision [57] on the cognitive component was identified with some professionals asking for this component to be removed completely. However, it is understood that the cognitive component of CBT-I leads to changes in dysfunctional beliefs about sleep which is predictive of positive outcomes [60, 61]. A stepped approach to CBT-I has been suggested [62] which would allow professionals such as GP’s or physiotherapists to deliver basic elements aligned with CBT-I, with a clear pathway for when to refer on to more skilled professionals, this might encourage professionals to use this treatment clinically.
Format
This review found CBT-I primarily took the form of individual and group face to face sessions, one study delivering individual sessions of telephone CBT-I [7] and another study delivering online sessions [42]. These findings closely aligned with two studies carried out on patients with chronic insomnia [63, 64], a study on cancer patients [65] and a study on traumatic brain injury patients [54] in relation to the mix of individual and group sessions and the delivery method.
The flexibility of format offers clinicians options when addressing some of the patient barriers faced when delivering CBT-I [53] such as limited time, available clinic hours, travel logistics and waiting times. However, a study exploring patients perspective of CBT-I format found that patients reported face to face delivery as superior to eCBT-I but they did feel that there was a place for eCBT-I for relapse management [66]. This study recommended that the patients perspective is explored prior to commencing treatment to ensure the format of CBT-I meets the need of each patient. Recent changes to healthcare delivery due to the pandemic has required services to become generally more flexible [67].
The range of delivery times for each intervention in this study is of note. It is difficult to compare the content of an individual course of CBT-I delivered over a total period of 120 minutes, a group intervention of 840 minutes delivered to a group of 5–12 patients and a group where no detail was provided on the session length. The variation in delivery time is not isolated to this cohort, numerous studies report similar findings for cancer patients [65, 68], traumatic brain injury patients [54] and insomnia [51]. This may be in part due to the option to tailor CBT-I components. Of the studies that delivered combined CBT-I and CBT-P, all had session lengths of 90 minutes, however the number of sessions delivered varied. Offering six sessions [41] instead of nine sessions [10, 37], translates to a difference of 260 minutes in total delivery time and is likely to lead to a reduction in the amount of CBT-I content delivered. The impact fewer sessions has on the amount of CBT-I content delivered, and the subsequent impact this may have on treatment outcomes for this combined approach warrants exploration.
There appears to be consistency in the amount of sessions delivered in this review however, this contrasts to the four individual biweekly sessions that have been shown to be the most effective [69]. In addition a study delivering CBT-I to chronic insomnia patients found a week by week improvement in TST [47]. It is yet to be determined if the variation in amount of sessions in this review from 5 to 9 weeks could impact the intervention and this would benefit from further research.
Strengths and limitations
The strengths of this review include the prospective protocol registration, following the PRISMA ScR guidance, searching comprehensively across nine databases and the inclusion of PEDro scores. The structured approach to data analysis offered by using the TIDieR Checklist is also a strength of this study. This review focussed on RCTs which could limit the findings, however we are reassured as a systematic review of CBT-I with a different focus published in 2021, included the same ten studies published at this time [8]. Studies were limited to English or those translated to English. There may be gender bias in this review due to the largely female sample in the associated studies (82%), although this may reflects the dominance of female patients with FM. Lack of detail provided by the studies for the TIDieR items make it difficult to compare each intervention, this limitation is compounded by the inconsistency in the terminology used across the studies.
Clinical implications
If looking to deliver CBT-I clinically for this cohort, this review has found that current CBT-I programmes always deliver sleep restriction and stimulus control and frequently deliver a cognitive component, sleep hygiene, sleep education, a form ofs relaxation and relapse prevention. Further research in defining the content of each core component along with the terminology and the creation of guidelines would help to address the lack of details in the studies included.
Fidelity was assessed in ten studies with some studies providing details of thorough strategies to ensure fidelity and adherence. In a clinical environment it does not appear feasible nor realistic to carry out the breadth of strategies described, although ensuring all therapists have received suitable training and follow a treatment manual may be more feasible. The use of adherence questionnaires could be easily implemented but the honesty of the responses might be compromised due to limited anonymity in the clinical environment.
Future research
This scoping review highlights the need to define the content of each core component along with the terminology, perhaps with a view to creating a CBT-I guideline. Exploration into component selection for specific conditions such as OA or FM would be helpful. Further exploration into how much training therapists would need to feel competent to carry out CBT-I and the associated delivery and training costs would be beneficial.
Conclusion
These findings demonstrate considerable consistency in both the components of CBT-I delivered in clinical trials along with the number of sessions. The frequency of sessions was also consistent where almost all studies held weekly sessions. However, some aspects were either not reported (e.g., content of components) or not consistent (e.g., use of terminology). CBT-I was delivered both individually and in groups. Lack of detail provided across the studies impacted the ability to compare the interventions. Greater consistency, and more detailed reporting regarding who delivered the intervention, the training provided, and the specific content of CBT-I components would be of great benefit.
Supporting information
S2 Fig. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
https://doi.org/10.1371/journal.pone.0305931.s002
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S3 Fig. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist.
https://doi.org/10.1371/journal.pone.0305931.s003
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Acknowledgments
We acknowledge the support of Liz Dore, Faculty of Education and Health Sciences librarian at the Glucksman Library in the University of Limerick, for her assistance with the development of the search strategy.
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