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Sleep-Well
Metacognitive Behavioral Therapy Integrated in Sleep Treatment for Comorbid Insomnia in Patients With Persistent Pain: A Randomized Controlled Semi-Crossover Clinical Trial
Sponsor study identifier
interventional
106
1 country
1
Study Start
January 1, 2025
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The "Sleep-Well" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality. Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital. Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression. The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 29, 2024
Actual (reported)April 8, 2024
Actual (reported)January 1, 2025
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Insomnia symptoms
The Bergen Insomnia Scale (5 items, item score range 0-7 days) assesses the number of days per week with nighttime sleeping symptoms lasting more than 30 minutes (SOL-sleep onset latency, WASO-wake after sleep onset and EMA-early morning awakening without regaining sleep), and daytime problems (in number of days per week) related to general dissatisfaction and functional problems in school, work or social life. Symptoms that have a duration of \>3 months and occur more than \>3 days a week satisfy the inclusion criteria for insomnia.
Baseline and post-test (3 months), plus follow-up at 3 and 12 months.
Insomnia diagnosis
The Duke Structured Diagnostic Interview for Sleep Disorders (Norwegian version translated by National Competence Center of Sleep Medicine in Bergen). is used to determine whether the DSM-5 criteria for insomnia are met. It is also used to make a clinical judgement of whether patients having other sleep issues, such as restless legs or sleep apnea, should be excluded.
Baseline and post-test (3 months)
The treatment-as-usual arm.
The study arm that receives the Sleep-Well intervention.
The Sleep-Well program covers four overarching topics stretched over 7 group sessions (each lasting \~1.5 hours): 1) providing information about sleep physiology, causes of sleep problems, sleep habits and hygiene and use of sleep assessment methods (i.e., sleep diaries) for deciding sleep restriction schedules; 2) behavioural strategies through the application of stimulus control and sleep restriction; , 3) mental strategies by addressing and changing unhelpful (meta)cognitions that commonly occur in sleep and persistent pain conditions; and 4) strategies related to maintenance of good sleep and prevention of relapse. The program has been developed by Diakonhjemmet hospital in Oslo and includes a guideline for therapist and a workbook for patients (that includes home tasks for the participant).
UiT The Arctic University of Norway
Tromsø, Troms County, 9037, Norway
Rosenvinge JH, Bergvik S, Abeler K, Tvedt K, Berge T, Lang N, Wilhelmsen M, Danielsson L, Pettersen G, Friborg O. The "SleepWell" intervention for patients with insomnia and persistent pain: a study protocol for a randomised waiting-list controlled trial of a cognitive behavioural group therapy programme. Trials. 2025 Aug 27;26(1):314. doi: 10.1186/s13063-025-09041-z.
Oddgeir Friborg, PhD
UiT The Arctic University of Norway
First Submitted
February 29, 2024
First Posted
April 8, 2024
Study Start
January 1, 2025
Actual (reported)Actigraphy insomnia indicators (SOL, WASO and EMA in minutes)
Actiwatch Spectrum Plus from Phillips Respironics is used to record motion and bright light exposure during sleep. The actigraphy clock is worn on the left arm for 7 days. Outcome variables are Sleep Onset Latency (SOL; duration in minutes from initiation to falling asleep), Wake After Sleep Onset (WASO; duration in minutes of nightly awakenings), and Early Morning Awakening (EMA; duration in minutes from last wakeup to leaving bed).
Baseline and post-test (3 months), plus follow-up at 3 and 12 months.
Actigraphy insomnia indicators (SE %)
Actiwatch Spectrum Plus from Phillips Respironics is used to record motion and bright light exposure during sleep. The actigraphy clock is worn on the left arm for 7 days. Outcome variable is Sleep Efficiency (SE; proportion of sleeping time to total time spent in bed). SE% = Duration of time in sleep / Duration of time in bed.
Baseline and post-test (3 months), plus follow-up at 3 and 12 months.
Sleep diary insomnia indicators (SOL, WASO and EMA in minutes)
Subjects complete a sleep diary log for a week following their participation in each sleep intervention module. The weekly sleep log is used to find and adjust the recommended bedtime concerning the participant's sleep restriction schedule. But as a primary outcome, it estimates Sleep Onset Latency (SOL; duration in minutes from initiation to falling asleep), Wake After Sleep Onset (WASO; duration in minutes of nightly awakenings) and Early Morning Awakening (EMA; duration in minutes from last wakeup to leaving bed) as indicators of insomnia.
Between baseline and post-test (3 months): Five repeated measures across five weeks
Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST)
Baseline and post-test (3 months)
Anxiety and depression (HADS)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
Quality of Life (EQ-5Q-5L)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
Fatigue (Chalder Fatigue Scale)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
Pain intensity, interference and locations (BPI)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
Mediator: Sleep hygiene (SHI)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
Hyperactivity (HAS)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
Mediator: Dysfunctional beliefs and attitudes about sleep (DBAS)
Baseline and post-test (3 months), plus follow-up at 3 and 12 months
The treatment-as-usual arm represents an active waiting-list arm as subjects receive standard care, which may involve some sleep assessment, rudimentary advice/education about sleep, and possibly also sleep medication. The type of sleep treatment this group receives during the waiting-list period will be recorded from the patients' journal.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 24, 2025
Record last verified: 2024-03
The project will collect considerable information about the health and clinical status of the patients, and their clinical response. After the publication of the primary outcome results, we plan to conduct numerous additional secondary outcome and exploratory analyses (e.g., mediation and moderation effects). The timeline for the entire publication process is uncertain, and we prefer not to upload anonymized patient data until most of these data have been analyzed and published. However, researchers interested in reanalyzing published data may contact the principal investigator and apply for data access.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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