Sleep, Pain and Quality of Life in Chronic Pain Patients

March 20, 2024 updated by: Reetta Sipilä, Helsinki University Central Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

554

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • HUH Pain Clinic
      • Turku, Finland
        • Turku University Hospitla Pain Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • fluency in Finnish

Exclusion Criteria:

  • severe psychiatric conditions (e.g. scizopherenia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life (HrQoL) questionnaire (15D)
Time Frame: Change from Baseline HrQoL at 12 months
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
Time Frame: 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.
Change from Baseline mood at 12 months
Pain related catastrophizing (PCS)
Time Frame: Change from Baseline pain related catatsrophizing at 12 months
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
Time Frame: 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.
Change from Baseline stress and worrying tendency at 12 months
Brief Pain Inventory (BPI)
Time Frame: 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.
Change from Baseline pain intensity and interference at 12 months
Insomnia Severity Index (ISI)
Time Frame: 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.
Change from Baseline symptoms of insomnia at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Turku University Hospital
University of Helsinki

Investigators

  • Principal Investigator: Eija A Kalso, Professor, Helsinki University Hospital, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/577/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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