NCT04265586

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3.4 years

First QC Date

January 24, 2020

Last Update Submit

March 20, 2024

Conditions

Chronic PainInsomnia

Keywords

Health-related Quality of LifeAnxietyPain intensityPain interferenceSymptoms of insomnia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mood -BDI-II and STAI-Y

    Change from Baseline mood at 12 months

  • Pain related catastrophizing (PCS)

    Change from Baseline pain related catatsrophizing at 12 months

  • Stress and worrying tendency

    Change from Baseline stress and worrying tendency at 12 months

  • Brief Pain Inventory (BPI)

    Change from Baseline pain intensity and interference at 12 months

  • Insomnia Severity Index (ISI)

    Change from Baseline symptoms of insomnia at 12 months

Study Arms (3)

No insomnia

NO INTERVENTION

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

Digital Cognitive Behavioural Therapy (iCBT)

EXPERIMENTAL

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)

Sleep hygiene education

EXPERIMENTAL

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

Interventions

EducationBEHAVIORAL

Sleep hygiene education is either face-to-face appointment or "video-meeting" with trained nurse.

Sleep hygiene education
Web-based Cognitive Behavioural Therapy (iCBT)BEHAVIORAL

iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.

Digital Cognitive Behavioural Therapy (iCBT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fluency in Finnish

You may not qualify if:

  • severe psychiatric conditions (e.g. scizopherenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HUH Pain Clinic

Helsinki, Finland

Location

Turku University Hospitla Pain Clinic

Turku, Finland

Location

MeSH Terms

Conditions

Chronic PainSleep Initiation and Maintenance DisordersAnxiety DisordersPain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Eija A Kalso, Professor

    Helsinki University Hospital, University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 24, 2020

First Posted

February 11, 2020

Study Start

August 14, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)