Sleep, Pain and Quality of Life in Chronic Pain Patients

Study Overview
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Brief Summary
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The interventional study will have two main aims. First, to compare two interventions aiming to improve sleep in chronic pain patients. And secondly, to study the associations of sleep, mood, chronic pain and quality of life. Half of participants will go through iCBT intervention for insomnia and the other half will receive sleep hygiene education. Additionally, the study will gather information which patients will benefit/will not benefit the tertiary pain clinic treatment when the outcome variable is the Health-related Quality of Life (HrQoL).

Detailed Description
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Sleep disturbances associates closely with chronic pain. It now seems that sleep problems usually precede and maintain persistent pain. Anxiety and worry frequently precede and associate with disturbed sleep and chronic pain. Depression is usually a consequence of chronic pain. Pain and depression disturb sleep further. These elements form a vicious circle where poor sleep is a critical driver. Previous studies have shown that sleep disturbances are a major contributor to the poor health-related quality of life (HRQoL) of patients with chronic pain.

Official Title
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Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study

Conditions
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Chronic Pain, Insomnia

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Web-based Cognitive Behavioural Therapy (iCBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fluency in Finnish Exclusion Criteria: severe psychiatric conditions (e.g. scizopherenia)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No insomnia<br>This group contains participants who report only mild symptoms of insomnia (Insomnia Severity Index, ISI<15). | |
| Experimental: Digital Cognitive Behavioural Therapy (iCBT)<br>This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI >14). Intervention is iCBT for participants with insomnia (7-16 weeks). | Behavioral: Web-based Cognitive Behavioural Therapy (iCBT)<br>* iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.<br>|
| Experimental: Sleep hygiene education<br>This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI >14). Sleep hygiene education (approximately 1 hour) | Behavioral: Education<br>* Sleep hygiene education is either face-to-face appointment or video-meeting with trained nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life (HrQoL) questionnaire (15D) | 15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL | Change from Baseline HrQoL at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood -BDI-II and STAI-Y | Questionnaires about depression and anxiety, BDI-II values ranging from 0-63, and STAI-Y values ranging form 20-80 for both state and trait anxiety. Higher values in both questionnaires indicates higher amount of asked symptom. | Change from Baseline mood at 12 months | 
| Pain related catastrophizing (PCS) | Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency. | Change from Baseline pain related catatsrophizing at 12 months | 
| Stress and worrying tendency | Questionnaires about perceived stress and worrying tendency. Values ranges from 16 to 80, higher values indicating higher amount of worring tendency. | Change from Baseline stress and worrying tendency at 12 months | 
| Brief Pain Inventory (BPI) | 12-item questionnaire abour self-reported pain intensity and interference. Values ranges from 0 to 120, higher values indicating higher amount of pain interference and intensity. | Change from Baseline pain intensity and interference at 12 months | 
| Insomnia Severity Index (ISI) | 5-item questionnaire of self-reported symptoms of insomnia. Values ranging from 0 to 28, higher values indicating higer amount of symptoms of insomnia. | Change from Baseline symptoms of insomnia at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health-related Quality of Life, Anxiety, Pain intensity, Pain interference, Symptoms of insomnia