Chronic PainNCT06545513
Depression and Anxiety Among Chronic Pain Patients in the Netherlands
An observational study of Chronic Pain and Depression, Anxiety, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The aim of this study is to examine the prevalence of anxiety and depression among patients with chronic pain attending secondary and tertiary pain clinics in the Netherlands. Additionally, the study explores how pain intensity, sociodemographic factors, and the presence of anxiety or depression are associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Depression, Anxiety
- How many people
- 3,240 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2022to 19 Nov 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic pain under treatment at chronic pain outpatient clinics at Amsterdam UMC.
Patients over 18 years old with chronic pain, who have been treated at the pain clinic at Amsterdam UMC from 2020 to 2024, will be included in the study, provided they have completed the HADS questionnaires in full. Patients with incomplete HADS questionnaires and those who have filed a general objection to the use of their data for this scientific research will be excluded from participation in the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Depression and Anxiety Among Chronic Pain Patients in the Netherlands
The aim of this study is to examine the prevalence of anxiety and depression among patients with chronic pain attending secondary and tertiary pain clinics in the Netherlands. Additionally, the study explores how pain intensity, sociodemographic factors, and the presence of anxiety or depression are associated with quality of life in this population.
Using an anonymized dataset provided by the data manager, we aimed to prevent a low response rate at Amsterdam UMC and thereby reduce the risk of non-response bias.
Read the detailed description
Chronic pain is defined as pain which exists for a period longer than 3 months. The prevalence of chronic pain in the Netherlands is estimated to be 19 percent. Chronic pain is a complex disorder which is often challenging to treat. The dynamic interaction between de different aspects of chronic pain, like the somatic, physical and social aspects, make the treatment challenging. Patients with chronic pain have a three times increased risk of developing psychiatric symptoms (usually mood and anxiety disorders) and vice versa, patients with depression have a three times increased risk of developing chronic pain. Also independently chronic pain and depression are both invalidating disorders, regardless of age and gender. It has been found that there is an increased risk of suicide among patients with chronic pain. The complex interaction between chronic pain and depression and their cumulative effect on the quality of life in the Netherlands has not yet been completely identified. This is because the interaction between chronic pain and depression is not yet fully understood. The treatment can be improved when the interaction between pain and depression is better understood.
The research acts as a preliminary investigation for the treatment of patients with chronic pain with intrvenous esketamine, a recently approved treatment for treatment resistant depression.
- Conditions
- Chronic Pain, Depression, Anxiety
- Keywords
- Chronic pain, Depression, Anxiety
- Medical subject headings
- Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic pain | The patients have completed surveys prior or during their visit at the chronic pain outpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression
prevalence of depression among chronic pain patients
Measured: 2020-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Aug 2022
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies Smits, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545513
- Sponsor's protocol ID
- 2022.0372
- Status last verified
- May 2025
- First submitted
- 5 Aug 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Racine M. Chronic pain and suicide risk: A comprehensive review. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Dec 20;87(Pt B):269-280. doi: 10.1016/j.pnpbp.2017.08.020. Epub 2017 Aug 26.
PubMed 28847525Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
PubMed 16095934Magni G, Marchetti M, Moreschi C, Merskey H, Luchini SR. Chronic musculoskeletal pain and depressive symptoms in the National Health and Nutrition Examination. I. Epidemiologic follow-up study. Pain. 1993 May;53(2):163-168. doi: 10.1016/0304-3959(93)90076-2.
PubMed 8336986Carroll LJ, Cassidy JD, Cote P. Depression as a risk factor for onset of an episode of troublesome neck and low back pain. Pain. 2004 Jan;107(1-2):134-9. doi: 10.1016/j.pain.2003.10.009.
PubMed 14715399
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Depression and Anxiety Among Chronic Pain Patients in the Netherlands
- ClinicalTrials.gov ID
- NCT06545513
- Acronym / sponsor ID
- 2022.0372
- Conditions
- Chronic Pain, Depression, Anxiety
- Keywords
- Chronic pain, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,240 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 9 Aug 2024 (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 aim of this study is to examine the prevalence of anxiety and depression among patients with chronic pain attending secondary and tertiary pain clinics in the Netherlands. Additionally, the study explores how pain intensity, sociodemographic factors, and the presence of anxiety or depression are associated with quality of life in this population.
Using an anonymized dataset provided by the data manager, we aimed to prevent a low response rate at Amsterdam UMC and thereby reduce the risk of non-response bias.
Detailed description
Chronic pain is defined as pain which exists for a period longer than 3 months. The prevalence of chronic pain in the Netherlands is estimated to be 19 percent. Chronic pain is a complex disorder which is often challenging to treat. The dynamic interaction between de different aspects of chronic pain, like the somatic, physical and social aspects, make the treatment challenging. Patients with chronic pain have a three times increased risk of developing psychiatric symptoms (usually mood and anxiety disorders) and vice versa, patients with depression have a three times increased risk of developing chronic pain. Also independently chronic pain and depression are both invalidating disorders, regardless of age and gender. It has been found that there is an increased risk of suicide among patients with chronic pain. The complex interaction between chronic pain and depression and their cumulative effect on the quality of life in the Netherlands has not yet been completely identified. This is because the interaction between chronic pain and depression is not yet fully understood. The treatment can be improved when the interaction between pain and depression is better understood.
The research acts as a preliminary investigation for the treatment of patients with chronic pain with intrvenous esketamine, a recently approved treatment for treatment resistant depression.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic pain | – | –The patients have completed surveys prior or during their visit at the chronic pain outpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain under treatment at chronic pain outpatient clinics at Amsterdam UMC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of depression
Time frame: 2020-2024
prevalence of depression among chronic pain patients
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 14 May 2025.
- Background: PubMed 28847525Racine M. Chronic pain and suicide risk: A comprehensive review. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Dec 20;87(Pt B):269-280. doi: 10.1016/j.pnpbp.2017.08.020. Epub 2017 Aug 26.
- Results publication: PubMed 16095934Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
- Results publication: PubMed 8336986Magni G, Marchetti M, Moreschi C, Merskey H, Luchini SR. Chronic musculoskeletal pain and depressive symptoms in the National Health and Nutrition Examination. I. Epidemiologic follow-up study. Pain. 1993 May;53(2):163-168. doi: 10.1016/0304-3959(93)90076-2.
- Results publication: PubMed 14715399Carroll LJ, Cassidy JD, Cote P. Depression as a risk factor for onset of an episode of troublesome neck and low back pain. Pain. 2004 Jan;107(1-2):134-9. doi: 10.1016/j.pain.2003.10.009.
- International Classification of Disease (11th version)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Depression, Anxiety, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Prevalence of depression (time frame: 2020-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545513, which also lists 4 linked publications.
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 14 May 2025.