Chronic PainNCT04265586
Sleep, Pain and Quality of Life in Chronic Pain Patients
A study testing Education and Web-based Cognitive Behavioural Therapy (iCBT) in people with Chronic Pain and Insomnia, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Insomnia
- What is being tested?
- Education and Web-based Cognitive Behavioural Therapy (iCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 2 sitesFinland
- Study dates
- 14 Aug 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fluency in Finnish
Who cannot join
- severe psychiatric conditions (e.g. scizopherenia)
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
HUH Pain Clinic
Helsinki
Turku University Hospitla Pain Clinic
Turku
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Pain, Insomnia
- Being tested
- Education, Web-based Cognitive Behavioural Therapy (iCBT)
- Keywords
- Health-related Quality of Life, Anxiety, Pain intensity, Pain interference, Symptoms of insomnia
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Sleep hygiene education is either face-to-face appointment or "video-meeting" with trained nurse.
Web-based Cognitive Behavioural Therapy (iCBT)Behavioural
iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life (HrQoL) questionnaire (15D)
15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL
Measured: Change from Baseline HrQoL at 12 months
Secondary outcomes (5)
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.
Measured: Change from Baseline mood at 12 months
Pain related catastrophizing (PCS)
Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency.
Measured: Change from Baseline pain related catatsrophizing at 12 months
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.
Measured: Change from Baseline stress and worrying tendency at 12 months
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.
Measured: Change from Baseline pain intensity and interference at 12 months
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.
Measured: Change from Baseline symptoms of insomnia at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start14 Aug 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Turku University Hospital
- Responsible party
- Principal investigator, Reetta Sipilä, Helsinki University Central Hospital
- Investigators
- Eija A Kalso, Professor, Principal investigator, Helsinki University Hospital, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265586
- Sponsor's protocol ID
- HUS/577/2019
- Status last verified
- Mar 2024
- First submitted
- 24 Jan 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study
- ClinicalTrials.gov ID
- NCT04265586
- Acronym / sponsor ID
- HUS/577/2019
- Conditions
- Chronic Pain, Insomnia
- Keywords
- Health-related Quality of Life, Anxiety, Pain intensity, Pain interference, Symptoms of insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Turku University Hospital
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Web-based 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). |
| Sleep hygiene education | Experimental | Behavioral: EducationThis group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI >14). Sleep hygiene education (approximately 1 hour) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fluency in Finnish
Key exclusion criteria (1 listed)
- severe psychiatric conditions (e.g. scizopherenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationSleep hygiene education is either face-to-face appointment or "video-meeting" with trained nurse. | Behavioural | Sleep hygiene education |
| Web-based Cognitive Behavioural Therapy (iCBT)iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia. | Behavioural | Digital Cognitive Behavioural Therapy (iCBT) |
Primary outcome
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
5 secondary outcomes
Mood -BDI-II and STAI-Y
Time frame: Change from Baseline mood at 12 months
Pain related catastrophizing (PCS)
Time frame: 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
Brief Pain Inventory (BPI)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija A Kalso, Professor principal investigator
Helsinki University Hospital, University of Helsinki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Web-based Cognitive Behavioural Therapy (iCBT) in people with Chronic Pain and Insomnia, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (HrQoL) questionnaire (15D) (time frame: Change from Baseline HrQoL at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.