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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)

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

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

NCT ID

NCT04265586

First Posted

January 24, 2020

Last Updated

September 26, 2023

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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Sleep, Pain and Quality of Life in Chronic Pain Patients

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