Sleep, Pain and Quality of Life in Chronic Pain Patients

NCT ID: NCT04265586

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No insomnia

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Web-based Cognitive Behavioural Therapy (iCBT)

Intervention Type BEHAVIORAL

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

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)

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education

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

Intervention Type BEHAVIORAL

Web-based Cognitive Behavioural Therapy (iCBT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* fluency in Finnish

Exclusion Criteria

* severe psychiatric conditions (e.g. scizopherenia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Helsinki

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Reetta Sipilä

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eija A Kalso, Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital, University of Helsinki

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HUH Pain Clinic

Helsinki, , Finland

Site Status

Turku University Hospitla Pain Clinic

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUS/577/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Meditation for Pain
NCT03495726 COMPLETED NA
Enhanced CBTi for Older Adult Sleep and Cognition
NCT05015803 COMPLETED PHASE2/PHASE3