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Sleep, Pain and Quality of Life in Chronic Pain Patients

Primary Purpose

Chronic Pain, Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Education
Web-based Cognitive Behavioural Therapy (iCBT)
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Health-related Quality of Life, Anxiety, Pain intensity, Pain interference, Symptoms of insomnia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • fluency in Finnish

Exclusion Criteria:

  • severe psychiatric conditions (e.g. scizopherenia)

Sites / Locations

  • HUH Pain ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No insomnia

Digital Cognitive Behavioural Therapy (iCBT)

Sleep hygiene education

Arm Description

This group contains participants who report only mild symptoms of insomnia (Insomnia Severity Index, ISI<15).

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).

This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI >14). Sleep hygiene education (approximately 1 hour)

Outcomes

Primary Outcome Measures

Health-related Quality of Life (HrQoL) questionnaire (15D)
15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL

Secondary Outcome Measures

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.
Pain related catastrophizing (PCS)
Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency.
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.
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.
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.

Full Information

First Posted
January 24, 2020
Last Updated
September 26, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT04265586
Brief Title
Sleep, Pain and Quality of Life in Chronic Pain Patients
Official Title
Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Insomnia
Keywords
Health-related Quality of Life, Anxiety, Pain intensity, Pain interference, Symptoms of insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No insomnia
Arm Type
No Intervention
Arm Description
This group contains participants who report only mild symptoms of insomnia (Insomnia Severity Index, ISI<15).
Arm Title
Digital Cognitive Behavioural Therapy (iCBT)
Arm Type
Experimental
Arm Description
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).
Arm Title
Sleep hygiene education
Arm Type
Experimental
Arm Description
This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI >14). Sleep hygiene education (approximately 1 hour)
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Sleep hygiene education is either face-to-face appointment or "video-meeting" with trained nurse.
Intervention Type
Behavioral
Intervention Name(s)
Web-based Cognitive Behavioural Therapy (iCBT)
Intervention Description
iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.
Primary Outcome Measure Information:
Title
Health-related Quality of Life (HrQoL) questionnaire (15D)
Description
15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL
Time Frame
Change from Baseline HrQoL at 12 months
Secondary Outcome Measure Information:
Title
Mood -BDI-II and STAI-Y
Description
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.
Time Frame
Change from Baseline mood at 12 months
Title
Pain related catastrophizing (PCS)
Description
Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency.
Time Frame
Change from Baseline pain related catatsrophizing at 12 months
Title
Stress and worrying tendency
Description
Questionnaires about perceived stress and worrying tendency. Values ranges from 16 to 80, higher values indicating higher amount of worring tendency.
Time Frame
Change from Baseline stress and worrying tendency at 12 months
Title
Brief Pain Inventory (BPI)
Description
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.
Time Frame
Change from Baseline pain intensity and interference at 12 months
Title
Insomnia Severity Index (ISI)
Description
5-item questionnaire of self-reported symptoms of insomnia. Values ranging from 0 to 28, higher values indicating higer amount of symptoms of insomnia.
Time Frame
Change from Baseline symptoms of insomnia at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: fluency in Finnish Exclusion Criteria: severe psychiatric conditions (e.g. scizopherenia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eija A Kalso, Professor
Phone
+358947175885
Ext
75885
Email
eija.kalso@helsinki.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eija A Kalso, Professor
Organizational Affiliation
Helsinki University Hospital, University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUH Pain Clinic
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reetta Sipilä, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep, Pain and Quality of Life in Chronic Pain Patients

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