Chronic PainNCT06619171
Distress in Adolescents With Chronic Pain: Who is at Risk, When, and Why
An observational study of Chronic Pain, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
Living with chronic pain can be tough for any young person. But while some young people may experience distressing thoughts, others may not. No young person should face these problems alone. So, it's important to better understand who might be more vulnerable to distress, when, and why. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Chronic Pain
- How many people
- 70 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Oct 2024to Apr 2026
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We aim to recruit 70 adolescents (aged 12-19 years) with chronic pain.
Who may be able to join
- Participant is willing and able to give assent (aged 12-15 years) or informed consent (aged 16 years and older) for participation in the study,
- Parent/guardian is willing to give informed consent for participants aged 12-15 years.
- Adolescents aged 12 to 19 years.
- Were accepted for assessment at a tertiary specialist paediatric pain service, indicating by definition that they experience long-standing, treatment-resistant chronic pain that is functionally interfering.
- Able to read and converse fluently in English.
- Participant is willing to install the m-Path app on a smartphone that runs on Android or iOS to complete the daily assessments. (Please note that a recent Ofcom report has shown that by the age of 12 years, 98% of young people in the UK have their own mobile phone, used by 93% to access social media apps or sites. This supports the nearly universal access of smartphones in this age group)
Who cannot join
- If some serious acute pathology (e.g., infection, fracture, disease process (e.g., cancer with a potentially fatal trajectory)) or surgical procedure is the cause of the resulting pain complaint.
- If the patient is too psychologically unstable to safely participate in this research, based on clinical judgment (e.g., experiences of acute psychosis)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Bath Centre for Pain Services [BCPS]
Bath
Oxford Centre for Children and Young People in Pain [OxCYPP]
Oxford
About this study
Official title: Suicidal Distress in Adolescents With Chronic Pain: Who is at Risk, When, and Why?
Living with chronic pain can be tough for any young person. But while some young people may experience distressing thoughts, others may not. No young person should face these problems alone. So, it's important to better understand who might be more vulnerable to distress, when, and why. That way, healthcare professionals can be there for vulnerable youth when they need it most.
In total, 70 young people with chronic pain (aged 12-19 years) will be invited to take part. Over a 30-day period, they will answer a few questions about their pain and feelings five times per day (experience sampling part) and complete three detailed surveys (at the start, in the middle, and at the end).
Read more
This will help the investigators better understand how feelings of pain and distress might change over hours, days, and weeks. Plus, it might reveal which psychological and social factors might bring about these changes.
Answering these questions is vital as it will help healthcare professionals make sure vulnerable young people get the right care at the right time.
Read the detailed description
This study aims to address the following research questions:
- What are the factors (moderators) that determine why some adolescents with chronic pain may experience suicidal distress but not others, and through which mechanisms (mediators) does chronic pain increase such distress over time?
Primary objective:
The investigators will use the repeated survey data (at day 0, 15, and 31):
- To explore the extent to which pain interference (at baseline) is associated with suicidal distress (primarily hopelessness and entrapment, and secondarily suicidal and self-harm thoughts and behaviours), measured repeatedly over time.
Secondary objectives:
The investigators will use the experience sampling data (5x day/30 days: day 1-30) to explore:
- how the relationship between pain interference and suicidal distress unfolds in the patient's daily life.
- the moderators (collected at baseline, survey data) that determine why some young people with chronic pain may experience suicidal distress over time, but not others.
- the mechanisms (experience sampling items) underpinning the potential relationship between pain interference and suicidal distress in the patient's daily life.
- Conditions
- Chronic Pain
- Keywords
- Adolescents, Chronic Pain, Distress, Self-Harm, Suicidality, Experience Sampling
- Medical subject headings
- Chronic Pain, Self-Injurious Behavior, Suicidal Ideation
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopelessness
Hopelessness Scale for Children (HSC; 17 items) Response options: 1=True, 0=False (total score range: 0-17) The higher the score, the greater the hopelessness for the future.
Measured: day 0 (baseline), 15 (interim survey), and day 31 (final survey)
Entrapment
Short Defeat and Entrapment Scale (4 item entrapment subscale) Response options: 0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, 4 = extremely like me (total score range: 0-16) Higher scores indicate greater feelings of entrapment.
Measured: day 0 (baseline), 15 (interim survey), and day 31 (final survey)
Suicidal and self-harm thoughts and behaviours
10 separate items on the presence/ absence of suicidal and self-harm thoughts and behaviours.
Measured: day 0 (baseline), 15 (interim survey), and day 31 (final survey)
Secondary outcomes (3)
Hopelessness
single item on hopelessness, assessed repeatedly (5x/30 days) via experience sampling (ESM) Response options: 1 (not at all) - 7 (very much). Higher scores indicate greater feelings of hopelessness
Measured: day 1 to 30
Entrapment
single item on entrapment, assessed repeatedly (5x/30 days) via experience sampling (ESM).
Response options: 1 (not at all) - 7 (very much). Higher scores indicate greater feelings of entrapment.
Measured: day 1 to 30
Suicidal and self-harm thoughts and behaviours
single items on suicidal and self-harm thoughts and behaviours (5x/30 days), assessed repeatedly via experience sampling (ESM)
Measured: day 1 to 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start22 Oct 2024
- Primary completionAug 2025 (estimated)
- Study completionApr 2026 (estimated)
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 University of OxfordThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis, Medical Research Foundation, Royal United Hospitals Bath NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Verena Hinze, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619171
- Sponsor's protocol ID
- PID 17920
- Other IDs
- IRAS 341501, CPMS 64178, MRF-FEL-CAMPCF-23-105
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A fully de-identified version of the final dataset may be shared with third parties to support future research where it is in the public interest. We will also consider sharing study materials (including codebooks, measures, and analysis code files) openly upon completion of this study.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicidal Distress in Adolescents With Chronic Pain: Who is at Risk, When, and Why?
- ClinicalTrials.gov ID
- NCT06619171
- Acronym / sponsor ID
- PID 17920
- Conditions
- Chronic Pain
- Keywords
- Adolescents, Chronic Pain, Distress, Self-Harm, Suicidality, Experience Sampling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Versus Arthritis, Medical Research Foundation, Royal United Hospitals Bath NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Oct 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.
Living with chronic pain can be tough for any young person. But while some young people may experience distressing thoughts, others may not. No young person should face these problems alone. So, it's important to better understand who might be more vulnerable to distress, when, and why. That way, healthcare professionals can be there for vulnerable youth when they need it most.
In total, 70 young people with chronic pain (aged 12-19 years) will be invited to take part. Over a 30-day period, they will answer a few questions about their pain and feelings five times per day (experience sampling part) and complete three detailed surveys (at the start, in the middle, and at the end).
This will help the investigators better understand how feelings of pain and distress might change over hours, days, and weeks. Plus, it might reveal which psychological and social factors might bring about these changes.
Answering these questions is vital as it will help healthcare professionals make sure vulnerable young people get the right care at the right time.
Detailed description
This study aims to address the following research questions:
- What are the factors (moderators) that determine why some adolescents with chronic pain may experience suicidal distress but not others, and through which mechanisms (mediators) does chronic pain increase such distress over time?
Primary objective:
The investigators will use the repeated survey data (at day 0, 15, and 31):
- To explore the extent to which pain interference (at baseline) is associated with suicidal distress (primarily hopelessness and entrapment, and secondarily suicidal and self-harm thoughts and behaviours), measured repeatedly over time.
Secondary objectives:
The investigators will use the experience sampling data (5x day/30 days: day 1-30) to explore:
- how the relationship between pain interference and suicidal distress unfolds in the patient's daily life.
- the moderators (collected at baseline, survey data) that determine why some young people with chronic pain may experience suicidal distress over time, but not others.
- the mechanisms (experience sampling items) underpinning the potential relationship between pain interference and suicidal distress in the patient's daily life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We aim to recruit 70 adolescents (aged 12-19 years) with chronic pain.
Key inclusion criteria (6 listed)
- Participant is willing and able to give assent (aged 12-15 years) or informed consent (aged 16 years and older) for participation in the study,
- Parent/guardian is willing to give informed consent for participants aged 12-15 years.
- Adolescents aged 12 to 19 years.
- Were accepted for assessment at a tertiary specialist paediatric pain service, indicating by definition that they experience long-standing, treatment-resistant chronic pain that is functionally interfering.
- Able to read and converse fluently in English.
Key exclusion criteria (2 listed)
- If some serious acute pathology (e.g., infection, fracture, disease process (e.g., cancer with a potentially fatal trajectory)) or surgical procedure is the cause of the resulting pain complaint.
- If the patient is too psychologically unstable to safely participate in this research, based on clinical judgment (e.g., experiences of acute psychosis)
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
Hopelessness
Time frame: day 0 (baseline), 15 (interim survey), and day 31 (final survey)
Hopelessness Scale for Children (HSC; 17 items) Response options: 1=True, 0=False (total score range: 0-17) The higher the score, the greater the hopelessness for the future.
Entrapment
Time frame: day 0 (baseline), 15 (interim survey), and day 31 (final survey)
Short Defeat and Entrapment Scale (4 item entrapment subscale) Response options: 0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, 4 = extremely like me (total score range: 0-16) Higher scores indicate greater feelings of entrapment.
Suicidal and self-harm thoughts and behaviours
Time frame: day 0 (baseline), 15 (interim survey), and day 31 (final survey)
10 separate items on the presence/ absence of suicidal and self-harm thoughts and behaviours.
3 secondary outcomes
Hopelessness
Time frame: day 1 to 30
Entrapment
Time frame: day 1 to 30
Suicidal and self-harm thoughts and behaviours
Time frame: day 1 to 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Undecided. A fully de-identified version of the final dataset may be shared with third parties to support future research where it is in the public interest. We will also consider sharing study materials (including codebooks, measures, and analysis code files) openly upon completion of this study.
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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.
Verena Hinze, DPhil principal investigator
University of Oxford
2 sites 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, run by University of Oxford at 2 sites in United Kingdom.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 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 United Kingdom. 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?
Results are not available in the source record.
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?
Hopelessness (time frame: day 0 (baseline), 15 (interim survey), and day 31 (final survey)). The study lists 3 primary outcomes in all. 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 31 Oct 2024.