About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

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).
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.

Treatment groups

106 Participants

are divided into 2 treatment groups

Group A: TAU control armActive comparator 1 intervention

Group B: The Sleep-Well interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Baseline and post-test (3 months), plus follow-up at 3 and 12 months.

2

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.

Time frame

Baseline and post-test (3 months)

3

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).

Time frame

Baseline and post-test (3 months), plus follow-up at 3 and 12 months.

4

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.

Time frame

Baseline and post-test (3 months), plus follow-up at 3 and 12 months.

Secondary outcomes

1

Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST)

The HST recordings provide a good picture of sleep architecture (duration and distribution of N1, N2, N3 and REM sleep). These recordings are made a minimum of two nights per patient, excluding the first night due to habituation effects on the following night. In addition, the arousal index is used to indicate sleep disturbances during the night. A HST device manufatured by Somnomedics GmbH is considered used.

Time frame

Baseline and post-test (3 months)

2

Anxiety and depression (HADS)

The Hospital Anxiety and Depression Scale (HADS: 7 anxiety + 7 depression items) is scored separately for anxiety and depression (sum score range 0-21, higher scores represents worse symptoms). The HADS subscale scores indicates the level of non-vegetative symptoms of anxiety and depression. A much-used cut-off score ≥ 8 may be used as a diagnostic marker of anxiety or depression.

Time frame