Sleep, Pain and Quality of Life in Chronic Pain Patients

Not Applicable

Completed

• Conditions: Chronic Pain; Insomnia
• Interventions: Behavioral: Education; Behavioral: Web-based Cognitive Behavioural Therapy (iCBT)

• Registration Number: NCT04265586
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-08-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

• fluency in Finnish

Exclusion Criteria

• severe psychiatric conditions (e.g. scizopherenia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep hygiene education	Education	This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI \>14). Sleep hygiene education (approximately 1 hour)
Digital Cognitive Behavioural Therapy (iCBT)	Web-based Cognitive Behavioural Therapy (iCBT)	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain related catastrophizing (PCS)	Change from Baseline pain related catatsrophizing at 12 months	Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency.
Stress and worrying tendency	Change from Baseline stress and worrying tendency at 12 months	Questionnaires about perceived stress and worrying tendency. Values ranges from 16 to 80, higher values indicating higher amount of worring tendency.
Insomnia Severity Index (ISI)	Change from Baseline symptoms of insomnia at 12 months	5-item questionnaire of self-reported symptoms of insomnia. Values ranging from 0 to 28, higher values indicating higer amount of symptoms of insomnia.
Mood -BDI-II and STAI-Y	Change from Baseline mood at 12 months	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.
Brief Pain Inventory (BPI)	Change from Baseline pain intensity and interference at 12 months	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.

Trial Locations

Locations (2)

HUH Pain Clinic; 🇫🇮 Helsinki, Finland

Turku University Hospitla Pain Clinic; 🇫🇮 Turku, Finland