RecruitingNot ApplicableNCT06351839

Sleep Well Despite Persistent Pain Symptoms

Metacognitive Behavioral Therapy Integrated in Sleep Treatment for Comorbid Insomnia in Patients With Persistent Pain: A Randomized Controlled Semi-Crossover Clinical Trial


Sponsor

University of Tromso

Enrollment

106 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • Patients who, after clinical examination at University hospital of Northern Norway (UNN) fill the criteria for a chronic non-malignant pain diagnosis according to ICD-10.
  • Satisfy criteria for a comorbid insomnia
  • Both first-time referrals and former referred patients.

Exclusion Criteria4

  • A comorbid drug abuse diagnosis (ICD-10)
  • An ongoing compensation and/or insurance case related to a health issue, illness or treatment
  • Drug treatment using >100 morphine equivalents
  • Participation in other group-based treatments at the UNN Pain Department or the Physical Outpatient Medical Clinic (must be completed before inclusion)

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Interventions

BEHAVIORALSleep-Well despite persistent pain

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).

BEHAVIORALTAU (treatment-as-usual)

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.


Locations(1)

UiT The Arctic University of Norway

Tromsø, Troms County, Norway

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NCT06351839


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