Sleep Well Despite Persistent Pain Symptoms

NCT06351839 | Recruiting

• 1 other identifier: 2024/500457(REK)
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia Chronic; Insomnia Due to Medical Condition; Pain, Chronic

Keywords

Insomnia; Comorbid insomnia; Chronic pain; MetaCognitive Therapy for Insomnia; Sleep Hygiene; Sleep Education; Sleep Restriction; Group therapy

Outcome Measures

Primary Outcomes (5)

• 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)

• 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

Secondary Outcomes (6)

• 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

Other Outcomes (6)

• 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

Study Arms (2)

TAU control arm

ACTIVE COMPARATOR

The treatment-as-usual arm.

Behavioral: TAU (treatment-as-usual)

The Sleep-Well intervention

EXPERIMENTAL

The study arm that receives the Sleep-Well intervention.

Behavioral: Sleep-Well despite persistent pain

Interventions

Sleep-Well despite persistent pain BEHAVIORAL

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).

The Sleep-Well intervention

TAU (treatment-as-usual) BEHAVIORAL

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.

TAU control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tromso: lead
• University Hospital of North Norway: collaborator
• Diakonhjemmet Hospital: collaborator

Study Sites (1)

UiT The Arctic University of Norway

Tromsø, Troms County, 9037, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 40866978 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain; Sleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Oddgeir Friborg, PhD

  UiT The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oddgeir Friborg, PhD

CONTACT

4777646772; oddgeir.friborg@uit.no

Svein Bergvik, PhD

CONTACT

4777646323; svein.bergvik@uit.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We randomize patients to receive either the Sleep-Well intervention or to the TAU condition (active waiting-list group). After 3 months, the TAU patients cross over and receive the Sleep-Well intervention; hence, the design is semi-crossover.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: April 8, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)