Group‑delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial

Background Insomnia is common in the general population and is a risk factor for ill-health, which highlights the importance of treating insomnia effectively and cost-efficiently. Cognitive-behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment due to its long-term effectiveness and few side-effects, but its availability is limited. The aim of this pragmatic, multicentre randomized controlled trial is to investigate the effectiveness of group-delivered CBT-I in primary care compared to a waiting-list control group. Methods A pragmatic multicentre randomized controlled trial will be conducted with about 300 participants recruited across 26 Healthy Life Centres in Norway. Participants will complete online screening and provide consent before enrolment. Those who meet the eligibility criteria will be randomized to a group-delivered CBT-I or to a waiting list according to a 2:1 ratio. The intervention consists of four two-hour sessions. Assessments will be performed at baseline, 4 weeks, 3- and 6 months post-intervention, respectively. The primary outcome is self-reported insomnia severity at 3 months post-intervention. Secondary outcomes include health-related quality of life, fatigue, mental distress, dysfunctional beliefs and attitudes about sleep, sleep reactivity, 7-day sleep diaries, and data obtained from national health registries (sick leave, use of relevant prescribed medications, healthcare utilization). Exploratory analyses will identify factors influencing treatment effectiveness, and we will conduct a mixed-method process evaluation to identify facilitators and barriers of participants’ treatment adherence. The study protocol was approved by the Regional Committee for Medical and Health Research ethics in Mid-Norway (ID 465241). Discussion This large-scale pragmatic trial will investigate the effectiveness of group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia, generating findings that are generalizable to day-to-day treatment of insomnia in interdisciplinary primary care services. The trial will identify those who would benefit from the group-delivered therapy, and will investigate the rates of sick leave, medication use, and healthcare utilization among adults who undergo the group-delivered therapy.publishedVersio

Usability and acceptability of an app (SELFBACK) to support self-management of low back pain: mixed methods study.

Self-management is the key recommendation for managing non-specific low back pain (LBP). However, there are well-documented barriers to self-management, therefore methods of facilitating adherence are required. Smartphone apps are increasingly being used to provide feedback and reinforcement to support self-management of long-term conditions such as LBP. The aim of this study was to assess the usability and acceptability of the selfBACK smartphone app, designed to support and facilitate self-management of non-specific LBP. The app provides weekly self-management plans, comprising physical activity, strength/flexibility exercises, and patient education. The plans are tailored to the patient's characteristics and symptom progress by using case-based reasoning methodology. The study was carried out in two stages, using a mixed-methods approach. All participants undertook surveys and semi-structured telephone interviews were conducted with a subgroup of participants. Stage 1 assessed an app version with only the physical activity component and a web-questionnaire that collects information necessary for tailoring the self-management plans. The physical activity component included monitoring of steps recorded by a wristband, goal-setting, and a scheme for sending personalised, timely and motivational notifications to the user's smartphone. Findings from stage 1 were used to refine the app and inform further development. Stage 2 investigated an app version that incorporated three self-management components (physical activity, exercises and education). A total of sixteen participants (age range 23-71 years) with ongoing or chronic non-specific LBP were included in stage 1, and eleven participants (age range 32-56) were included in stage 2. In stage 1, 94% of participants reported that the baseline questionnaire was easy to answer and 84% found completion time to be acceptable. Overall, participants were positive about the usability of the physical activity component but only 31% found the app functions to be well integrated. 90% of the participants were satisfied with the notifications and 80% perceived the notifications to be personalised. In stage 2, all participants reported that the web-questionnaire was easy to answer and the completion time acceptable. The physical activity and exercise components were rated useful by 80%, while 60% rated the educational component useful. Overall, participants were satisfied with the usability of the app; however, only 50% found the functions to be well integrated and 20% found them to be inconsistent. Overall, 80% of participants reported it to be useful for self-management. The interviews largely reinforced the survey findings in both stages. This study has demonstrated that participants considered the selfBACK app to be acceptable and usable, and that they thought it would be useful for supporting self-management of LBP. However, we identified some limitations and suggestions, which will be useful in guiding further development of the selfBACK app and other mHealth interventions

An app-delivered self-management program for people with low back pain: protocol for the selfBACK randomized controlled trial.

Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions

Effectiveness of app-delivered, tailored self-management support for adults with lower back pain–related disability

Importance: Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested. Objective: To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. Design, Setting, and Participants: This randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email. Interventions: The selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician. Main Outcomes and Measures: Primary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. Results: A total of 461 participants were included in the analysis; the population had a mean [SD] age of 47.5 [14.7] years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI, 0.06-1.51; P = .03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P = .01). Conclusions and Relevance Among adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness. Trial Registration ClinicalTrials.gov Identifier: NCT0379828

Acute effects of a work-related rehabilitation program on cardiovascular fitness, pain, and sleep

Aim: The aim of this study was to assess the short-term effects of a work-related rehabilitation program on cardiovascular fitness, musculoskeletal symptoms, and cardiac autonomic regulation during sleep, by comparing a group receiving long-stay rehabilitation (3.5 weeks) vs., a group receiving short-stay rehabilitation (4+4 days). Method: Three tests were performed on the patients enrolled for the work-related rehabilitation program: 1) Åstrand/Ryhming cycle test, 2) pressure pain threshold (PPT), and 3) heart rate variability during sleep. Subjective pain was scored on visual analogue scale (VAS). The pre-test measurements were performed on the first day of the intervention and post-test were performed during the last week of the intervention. Results: No significant within or between group differences were found for maximal oxygen uptake or HRV during sleep from pre- to post-test. No significant change was found in subjective pain scores, although PPT in trapezius and erector spinae were significantly decreased from pre- to post-test. There was no significant difference in change in pain between the short- and long-stay groups. Conclusion: The acute effect of the work-related rehabilitation program in cardiovascular fitness, autonomic regulation (indicated by HRV) and pain was small and mainly insignificant and there was no difference between the long-stay and short-stay groups. This study evaluated some of the factors that commonly are targeted in work-related rehabilitation programs, and the results highlight the importance of evaluating these programs. Future studies should investigate the long-term effect for the patients enrolled at the rehabilitation program. Keywords: Work-related rehabilitation, musculoskeletal disorders, cardiovascular fitness, pressure pain threshold, sleep quality

Low back pain: Prognostic and associated factors within a biopsychosocial framework

Korsryggsmerter: Prognostiske og assosierte faktorer innenfor et biopsykososialt rammeverk Korsryggsmerter er en av de ledende årsakene til nedsatt funksjon og arbeidsevne både i Norge og globalt, og fører til utstrakt bruk av helsetjenester og trygdeytelser. Personer med korsryggsmerter har ofte tilleggsplager innenfor de biopsykososiale områdene, som utbredt smerte, depresjon, angst og dårlig generell helse. Under bevegelse kan man ofte identifisere et avvikende bevegelsesmønster og mange har nedsatt arbeidsevne på grunn av ryggsmertene. Personer med slike tilleggsplager responderer dårligere på behandling og har økt forbruk av helsetjenester. For å bedre forståelsen om hvordan korsryggsmerter forløper, forbedre tilpasning av behandling, og å forebygge forverring, tilbakefall og funksjonstap hos personer med korsryggsmerter, er det derfor viktig å øke kunnskapen om i hvilken grad biopsykososiale faktorer påvirker både prognose og smerte- og funksjonsnivå hos personer med korsryggsmerter. Det overordnede formålet med doktorgradsarbeidet var å undersøke hvordan biopsykososiale faktorer som antall smertepunkt, psykologiske symptomer, funksjonsnivå, arbeidsevne og bevegelsesmønster påvirker prognosen og de funksjonelle følgene av korsryggplager. I tillegg ønsket vi å se om bevegelsesmønsteret hos pasienter med korsryggsmerter samvarierte med ‘fear-avoidance beliefs’. Første artikkel er en populasjonsbasert prognostisk studie med 10-11 års oppfølging. Artikkel 2 og 3 er observasjonsstudier av korsryggpasienter som fikk fysioterapibehandling, med tre og ni måneders oppfølging. Hovedfunnene i doktorgradsarbeidet var at tilleggsplager som utbredt smerte, psykologiske symptomer, nedsatt funksjon og dårlig generell helse reduserte sannsynligheten for å bli kvitt langvarige korsryggsmerter etter 10-11 år. Hos pasienter som oppsøkte fysioterapibehandling fant vi at flere smertepunkter, mer psykologiske symptomer og dårligere arbeidsevne var assosiert med dårligere funksjon, mer intense smerter og lavere livskvalitet over en tre måneders periode. Videre fant vi at bedring i arbeidsevne ved tre måneder var eneste faktor assosiert med klinisk betydningsfull bedring i både funksjon, smerte og livskvalitet ved tre måneder. Vi fant ingen klare sammenhenger mellom bevegelsesmønster og selvrapportert smerte- og funksjonsnivå. Redusert bevegelsesutslag ved ryggfleksjon/-ekstensjon hadde svak sammenheng med redusert funksjon, og lavere bevegelseshastighet i startfasen av en ryggfleksjon hadde svak sammenheng med økt ‘fear-avoidance beliefs’ for fysisk aktivitet. Studiene bidrar til økt forståelse om hvordan antall smertepunkt, psykologiske symptomer, funksjonsnivå, arbeidsevne og bevegelsesmønster påvirker prognosen hos personer med korsryggsmerter. Resultatene kan ha en betydning for klinisk resonnering og planlegging av behandlingsforløp hos personer med korsryggsmerter

Improved cardiorespiratory fitness after occupational rehabilitation in merged diagnostic groups

Abstract Background Various occupational inpatient rehabilitation programs are established in Norway. This study aimed to assess change in cardiorespiratory fitness, pain, anxiety, depression, and quality of life in persons on long-term sick leave due to musculoskeletal-, mental or unspecific disorders after participation in multicomponent inpatient occupational rehabilitation. Methods Twenty-five women and five men (mean age 45.2 years, SD 6.7, range 30–57) volunteered to participate in the study. The participants attended either 8 or 17 full days of occupational multicomponent rehabilitation including physical exercise, cognitive behavioral therapy in the form of acceptance and commitment therapy (ACT), and development of a tailored plan for return to work. Cardiorespiratory fitness was assessed by the Åstrand/Ryhming cycle test at the start and end of rehabilitation program, and at one-year follow-up. Changes in somatic and mental health were measured by questionnaires up to 4 months after start of the program. Results Linear mixed models showed that the maximal oxygen uptake increased by 1.1 mL°kg-1°min− 1 during the rehabilitation program and by 3.7 mL°kg-1°min− 1 at one-year follow-up. There were minor improvements in somatic and mental health, and quality of life. Conclusions This study indicates that occupational inpatient multicomponent rehabilitation including physical exercise and ACT may promote a long-term increase in physical exercise that is sufficient to induce a significant increase in cardiorespiratory fitness. Trial registration The current study is not registered, but is part of a larger trial registered at clinicaltrials.gov (No.: NCT01926574, registered 21. Aug 2013)

Influence of sleep problems and co-occurring musculoskeletal pain on long-term prognosis of chronic low back pain: the HUNT Study

Background We investigated the influence of sleeplessness and number of insomnia symptoms on the probability of recovery from chronic low back pain (LBP), and the possible interplay between sleeplessness and co-occurring musculoskeletal pain on this association. Methods The study comprised data on 3712 women and 2488 men in the Norwegian HUNT study who reported chronic LBP at baseline in 1995–1997. A modified Poisson regression model was used to calculate adjusted risk ratios (RRs) for the probability of recovery from chronic LBP at follow-up in 2006–2008, associated with sleep problems and co-occurring musculoskeletal pain at baseline. Results Compared with persons without sleeplessness, persons who often/always experienced sleeplessness had a lower probability of recovery from chronic LBP (RR 0.65, 95% CI 0.57 to 0.74 in women and RR 0.81, 95% CI 0.69 to 0.95 in men). Although there was no clear evidence of statistical interaction between sleeplessness and co-occurring musculoskeletal pain, women and men who often/always experienced sleeplessness and had ≥5 additional chronic pain sites had RRs of recovery of 0.40 (95% CI 0.33 to 0.48) and 0.59 (95% CI 0.45 to 0.78), respectively, compared with persons without sleeplessness and 1–2 chronic pain sites. Conclusion These findings suggest that preventing or reducing sleep problems among people with chronic LBP may have the potential of improving the long-term prognosis of this condition, also among those with several additional pain sites

Long-term changes in body weight and physical activity in relation to all-cause and cardiovascular mortality: the HUNT study

Background Most previous studies have relied on single measurements of body weight and physical activity and have not considered the interplay between long-term changes in body weight and physical activity in relation to mortality. The aim of the current study was therefore to examine the joint effect of changes in body weight and leisure-time physical activity over a period of ~ 10 years on all-cause and cardiovascular mortality. Methods The study population comprised 34,257 individuals who participated in the first (1984–86) and second (1995–97) waves of the HUNT Study, and were followed up through the Norwegian Cause of Death Registry until December 31st, 2013. We used Cox regression to estimate hazard ratios (HR) with 95% confidence intervals (CI) of death associated with changes in body weight and leisure-time physical activity. Results Compared to the reference group with stable weight who were long-term physically active, people who gained ≥5% of their weight had a HR for all-cause mortality of 1.54 (95% CI: 1.28–1.85) if they were long-term physically inactive; a HR of 1.23 (1.09–1.40) if they became physically active, and a HR of 1.00 (95% CI 0.94–1.06) if they were long-term physically active. The corresponding HRs for cardiovascular mortality were 1.57 (95% CI 1.17–2.12), 1.28 (95% CI 1.04–1.58) and 1.06 (95% CI 0.96–1.16), respectively. Long-term physical inactivity was associated with increased all-cause (HR 1.29; 95% CI 1.08–1.53) and cardiovascular (HR 1.37; 95% CI 1.05–1.79) mortality among those who were weight stable. Conclusions The risk of all-cause and cardiovascular mortality is particularly evident among people who gain weight while remaining inactive during a ~ 10 year period. However, participants who remained physically active had the lowest risk of premature mortality, regardless of maintenance or increase in weight. These findings suggest that there is an interplay between long-term changes in body weight and physical activity that should receive particular attention in the prevention of premature mortality

The influence of multisite pain and psychological comorbidity on prognosis of chronic low back pain: longitudinal data from the Norwegian HUNT Study

Objectives: This study aimed to investigate the prospective influence of multisite pain, depression, anxiety, self-rated health and pain-related disability on recovery from chronic low back pain (LBP). Setting: The data is derived from the second (1995–1997) and third (2006–2008) wave of the Nord-Trøndelag Health Study (HUNT) in Norway. Participants: The study population comprises 4484 women and 3039 men in the Norwegian HUNT Study who reported chronic LBP at baseline in 1995–1997. Primary outcome measures: The primary outcome was recovery from chronic LBP at the 11-year follow-up. Persons not reporting pain and/or stiffness for at least three consecutive months during the last year were defined as recovered. A Poisson regression model was used to estimate adjusted risk ratios (RRs) with 95% CIs. Results: At follow-up, 1822 (40.6%) women and 1578 (51.9%) men reported recovery from chronic LBP. The probability of recovery was inversely associated with number of pain sites (P-trend<0.001). Compared with reporting 2–3 pain sites, persons with only LBP had a slightly higher probability of recovery (RR 1.10, 95% CI 0.98 to 1.22 in women and RR 1.10, 95% CI 1.01 to 1.21 in men), whereas people reporting 6–9 pain sites had substantially lower probability of recovery (RR 0.58, 95% CI 0.52 to 0.63 in women and RR 0.70, 95% CI 0.63 to 0.79 in men). Poor/not so good self-rated general health, symptoms of anxiety and depression, and pain-related disability in work and leisure were all associated with reduced probability of recovery, but there was no statistical interaction between multisite pain and these comorbidities. Conclusions: Increasing number of pain sites was inversely associated with recovery from chronic LBP. In addition, factors such as poor self-rated health, psychological symptoms and pain-related disability may further reduce the probability of recovery from chronic LBP