Chronic PainNCT05418062
Group ACT for CD Pain- a Feasibility Study
A study testing Acceptance and commitment therapy (ACT) in people with Chronic Pain and Crohn Disease, run by King's College London at 1 site in United Kingdom.
Trial summary
Pain is a common symptom of inflammatory bowel disease (IBD) and has a significant impact on patient quality of life. Pain will frequently be the presenting complaint and is experienced throughout the disease course. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Crohn Disease
- What is being tested?
- Acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2023to Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Established diagnosis of CD according to clinical notes for a minimum of 6 months
- Moderate pain, defined as mean score ≥4/10 on both pain severity and pain interference questions the Brief Pain Inventory (BPI) - a validated cut-off to define moderate pain
- Duration of pain of at least 3 months
- No changes to CD medication made for the previous 2 months
Who cannot join
- Diagnosis of ulcerative colitis or indeterminate colitis
- Known diagnosis of dementia/psychosis or expressing active suicidal ideation on clinical assessment
- Currently undergoing other psychological therapy
- Primary source of pain is non-abdominal
- Non-fluency in verbal English
- Pain is identified as a part of acute flare where immediate change in medical treatment is more appropriate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Natalie Watson
London, SE1 8WA
Natalie Watson, Natalie.1.watson@kcl.ac.uk
Dr Wladyslawa Czuber-Dochan, wladzia.czuber-dochan@kcl.ac.uk
About this study
Official title: Managing Pain in People With Crohn's Disease: Feasibility Testing of an Acceptance and Commitment Group Therapy Intervention.
Pain is a common symptom of inflammatory bowel disease (IBD) and has a significant impact on patient quality of life. Pain will frequently be the presenting complaint and is experienced throughout the disease course. Up to 70% of patients experience pain in active disease, and up to half (20-50%) of patients will experience pain in remission.
Pain in IBD is widely recognised as a biopsychosocial construct, with visceral hypersensitivity, as well as depressive symptoms, anxiety, stress and fear avoidance correlating positively with IBD-pain. There is increasing understanding of the psychological interaction and need for psychological management within IBD. Psychological therapies such as Cognitive Behavioural Therapy (CBT) and acceptance and commitment therapy (ACT) have been used widely in other conditions, such as chronic pain, fatigue and irritable bowel syndrome (IBS).
Read more
Although neither ACT nor CBT have been used specifically for pain in IBD, ACT has become a regular therapy in the management of chronic pain and a large number of studies have found it to be effective, particularly in relation to improving functioning and decreasing distress, quality of life and physical wellbeing.
This study design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The research team aim to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
Read the detailed description
Aims:
This study aims to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
Design and setting:
The design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The researchers will invite participants aged 18 and over with a diagnosis of CD attending outpatient clinics at Guy's and St Thomas' NHS Foundation Trust and King's College Hospital NHS Foundation Trust to participate. With ~90 patients with CD attending the clinics each week, this represents one of the largest CD cohorts in the UK. Patients with CD attending the outpatients department will be screened for the presence of chronic pain using standard questionnaires. Individual cases will then be reviewed by a gastroenterologist to assess whether their IBD is stable and they are suitable for the study or whether their pain is part of an acute flare which necessitates a change in medical treatment. Only patients where it is thought pain is part of stable chronic disease will be recruited.
Sample size and recruitment:
This is a feasibility study and power calculations for a treatment effect are not applicable. Based on an expected follow-up rate of at least 75%, a two-sided confidence interval will extend no more than 12.5% of the observed proportion with a sample size of 48 patients, thus providing adequate precision estimates. Based on pilot work in the IBD clinics and our previous experience of running RCTs for psychological therapy in IBD, the researchers conservatively estimate that 25% of people approached will be both willing and eligible to participate. As such, a total of 192 people will be approached to meet the recruitment target. WCD will chair biweekly study meetings where recruitment will be reviewed and intensified if falling behind this trajectory.
Randomisation:
Participants will be randomly allocated (1:1) to the intervention or TAU control group using a web-based randomisation service, which employs block randomisation with randomly varying block sizes. Randomisation will be stratified by male/female sex. The researcher analysing the data will not be able to access the data until final database lock.
Intervention:
Half of the cohort (n=24) will be randomised initially to TAU, which will comprise usual care from the CD team and GP but no specific pain intervention except a CCUK information sheet on pain in CD. After completing 24 weeks of TAU, these patients will then crossover to the intervention.
The other half (n=24) will be randomised initially to the intervention group. In addition to TAU, the intervention group will undergo eight 90-minute sessions of weekly ACT in groups of 8 patients, all led by a single clinical psychologist accredited in ACT. The course is based on contemporary ACT models and tailored toward people with IBD with an emphasis on reducing the impact of pain on functioning and quality of life. The research team will develop a manual and observe the sessions for assessment of fidelity.
The manual will be adapted from one developed by co-applicant AD for use with people with IBD. It will be peer-reviewed by experienced ACT practitioners to ensure adherence to the model. Treatment commences with the therapist aiming to foster the therapeutic alliance; exploring the developing of chronic pain; and explaining the treatment model. Subsequent sessions will include exercises to increase patients' awareness of the long-term consequences of struggling to control pain; their willingness to experience pain; the development of personal value-based goals and their engagement in these. Treatment finishes with a review of progress and plans for barriers in future. Patients will be given weekly homework tasks to develop their individual value-based goals and explore barriers that appear for them. The aim of the sessions is to increase patients' awareness of misplaced control strategies and to relinquish these and to increase their value-based activities.
The therapist will maintain a log of completed and non-completed sessions and any adverse events. The therapist will receive weekly supervision with an experienced ACT therapist (AD) to maintain adherence to the treatment protocol; to discuss issues arising from sessions; and plan for subsequent sessions. Any current treatment for pain will continue and be recorded. Changes to analgesia during the study are not restricted and will likewise be recorded. People randomised initially to the intervention group will not subsequently undergo transfer to the TAU group, as outcomes such as pain may already have been improved by the intervention.
- Conditions
- Chronic Pain, Crohn Disease
- Being tested
- Acceptance and commitment therapy (ACT)
- Medical subject headings
- Chronic Pain, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapy (ACT)Behavioural
8 weekly 2 hour sessions of ACT group for CD patients with chronic pain. Manual available on request
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients randomised into Group 1 will begin the 8 week group first. Receives: Behavioral: Acceptance and commitment therapy (ACT) |
| Control crossover group | Other | Patients randomised into Group 2 will act as the control for the first 8 weeks and then cross over into the intervention arm. Receives: Behavioral: Acceptance and commitment therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rate
Do patients want to be recruited/ randomised into the study
Measured: Through study completion, an average of 24 weeks
retention rate
once randomised, do patients continue to engage in the study
Measured: Through study completion, an average of 24 weeks
completion rate
How many patients "complete" the intervention (Attend 5 or more sessions)
Measured: Through study completion, an average of 24 weeks
Secondary outcomes (10)
Pain severity
the BPI severity questions assess pain at its "worst," "least," "average," (each over the last 24 hours) and "now" (current pain)
Measured: Screening, Baseline, Week 8, and 24 after randomisation
The UK Inflammatory Bowel Disease Quality of Life Questionnaire
Quality of life: the UK IBDQ measures quality of life as measured in several domains: Emotional function, Bowel function, Social Function and Systemic function. Scale: None-> All/ almost all the time. Higher score means Higher level of impact from the condition.
Measured: Baseline, Week 8, and 24 after randomisation
The Inflammatory Bowel Disease-Fatigue questionnaire
This was developed by two of the study investigators (WCD and CN) alongside people with IBD and provides the only validated fatigue scale specific to IBD. Scale 0= None of the time 4= All of the time. Higher score indicates higher levels of Fatigue.
Measured: Baseline, Week 8, and 24 after randomisation
Depression, stress and anxiety:
The Depression Anxiety Stress Scales (DASS-21). Used previously in a study of ACT in IBD, this consists of three 7-item depression, anxiety, and stress survey tools Scale: 0=Did not apply to me at all. 3=Applied to me very much or most of the time. A higher score in each section indicates symptoms.
Measured: Baseline, Week 8, and 24 after randomisation
Pain Acceptance
The Chronic Pain Acceptance Questionnaire (CPAQ-8) which measures acceptance of chronic pain; attempts to avoid or control pain; and the degree of engagement in activities. Scale: 0= Never True, 6= Always True
Measured: Baseline, Week 8, and 24 after randomisation
IBD-Distress
The IBD-Distress Scale (IBD-DS), this 28-item scale (co-developed by WCD and CN) has good face and content validity and excellent internal consistency. Yes/ No , If Yes, Scale: 1= mildly distressing, 6=Highly Distressing. Higher scores indicates higher levels of distress.
Measured: Baseline, Week 8, and 24 after randomisation
Treatment evaluation
numerical ratings reflecting how interesting, successful and logical participants perceived the treatment to be on a scale of 0-10.
Measured: Post treatment Week 8, or 24
Impairment in functioning:.
The Work and Social Adjustment Scale (WSAS), which provides a 5-question index of impairment in functioning attributable to an identified problem. Scale 0= Not at all, 8=Very severely.
Measured: Baseline, Week 8, and 24 after randomisation
Pain Interference
the mean score on the pain interference questions on the BPI. This measures the degree to which pain has interfered with 7 daily activities (general activity, walking, work, mood, enjoyment of life, relations with others and sleep). This mean score will be used if more than 50% of the total items have been completed on a given administration. Scale: 0= Does not interfere, 10=Completely interferes
Measured: Screening, Baseline, Week 8, and 24 after randomisation
SIMPLE INDEX OF CROHN'S DISEASE ACTIVITY (Harvey & Bradshaw 1980)
- General Wellbeing: (Very well/slightly below par/poor/very poor/ Terrible), B) Abdominal pain (None, Mild, moderate, severe), C) Number of liquid stools per day:..... D) Abdomen feels Lumpy ( None, Dubious, Definite, Definite and tender), E) Complications please tick all that apply: Painful joints/ arthritis, Anal fissure/ fistula/ abcess, Mouth ulcers, Skin nodules or ulcers, Eye pain or inflammation (Red eyes), Liver Problems (e.g primary sclerosing cholangitis)
Measured: Screening, Baseline, Week 8, and 24 after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start11 Jan 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dr Wladyslawa Czuber-Dochan, Principal investigator, KCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418062
- Sponsor's protocol ID
- 314107
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Pain in People With Crohn's Disease: Feasibility Testing of an Acceptance and Commitment Group Therapy Intervention.
- ClinicalTrials.gov ID
- NCT05418062
- Acronym / sponsor ID
- 314107
- Conditions
- Chronic Pain, Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 11 Jan 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 14 Jun 2022 (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.
Pain is a common symptom of inflammatory bowel disease (IBD) and has a significant impact on patient quality of life. Pain will frequently be the presenting complaint and is experienced throughout the disease course. Up to 70% of patients experience pain in active disease, and up to half (20-50%) of patients will experience pain in remission.
Pain in IBD is widely recognised as a biopsychosocial construct, with visceral hypersensitivity, as well as depressive symptoms, anxiety, stress and fear avoidance correlating positively with IBD-pain. There is increasing understanding of the psychological interaction and need for psychological management within IBD. Psychological therapies such as Cognitive Behavioural Therapy (CBT) and acceptance and commitment therapy (ACT) have been used widely in other conditions, such as chronic pain, fatigue and irritable bowel syndrome (IBS).
Although neither ACT nor CBT have been used specifically for pain in IBD, ACT has become a regular therapy in the management of chronic pain and a large number of studies have found it to be effective, particularly in relation to improving functioning and decreasing distress, quality of life and physical wellbeing.
This study design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The research team aim to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
Detailed description
Aims:
This study aims to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
Design and setting:
The design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The researchers will invite participants aged 18 and over with a diagnosis of CD attending outpatient clinics at Guy's and St Thomas' NHS Foundation Trust and King's College Hospital NHS Foundation Trust to participate. With ~90 patients with CD attending the clinics each week, this represents one of the largest CD cohorts in the UK. Patients with CD attending the outpatients department will be screened for the presence of chronic pain using standard questionnaires. Individual cases will then be reviewed by a gastroenterologist to assess whether their IBD is stable and they are suitable for the study or whether their pain is part of an acute flare which necessitates a change in medical treatment. Only patients where it is thought pain is part of stable chronic disease will be recruited.
Sample size and recruitment:
This is a feasibility study and power calculations for a treatment effect are not applicable. Based on an expected follow-up rate of at least 75%, a two-sided confidence interval will extend no more than 12.5% of the observed proportion with a sample size of 48 patients, thus providing adequate precision estimates. Based on pilot work in the IBD clinics and our previous experience of running RCTs for psychological therapy in IBD, the researchers conservatively estimate that 25% of people approached will be both willing and eligible to participate. As such, a total of 192 people will be approached to meet the recruitment target. WCD will chair biweekly study meetings where recruitment will be reviewed and intensified if falling behind this trajectory.
Randomisation:
Participants will be randomly allocated (1:1) to the intervention or TAU control group using a web-based randomisation service, which employs block randomisation with randomly varying block sizes. Randomisation will be stratified by male/female sex. The researcher analysing the data will not be able to access the data until final database lock.
Intervention:
Half of the cohort (n=24) will be randomised initially to TAU, which will comprise usual care from the CD team and GP but no specific pain intervention except a CCUK information sheet on pain in CD. After completing 24 weeks of TAU, these patients will then crossover to the intervention.
The other half (n=24) will be randomised initially to the intervention group. In addition to TAU, the intervention group will undergo eight 90-minute sessions of weekly ACT in groups of 8 patients, all led by a single clinical psychologist accredited in ACT. The course is based on contemporary ACT models and tailored toward people with IBD with an emphasis on reducing the impact of pain on functioning and quality of life. The research team will develop a manual and observe the sessions for assessment of fidelity.
The manual will be adapted from one developed by co-applicant AD for use with people with IBD. It will be peer-reviewed by experienced ACT practitioners to ensure adherence to the model. Treatment commences with the therapist aiming to foster the therapeutic alliance; exploring the developing of chronic pain; and explaining the treatment model. Subsequent sessions will include exercises to increase patients' awareness of the long-term consequences of struggling to control pain; their willingness to experience pain; the development of personal value-based goals and their engagement in these. Treatment finishes with a review of progress and plans for barriers in future. Patients will be given weekly homework tasks to develop their individual value-based goals and explore barriers that appear for them. The aim of the sessions is to increase patients' awareness of misplaced control strategies and to relinquish these and to increase their value-based activities.
The therapist will maintain a log of completed and non-completed sessions and any adverse events. The therapist will receive weekly supervision with an experienced ACT therapist (AD) to maintain adherence to the treatment protocol; to discuss issues arising from sessions; and plan for subsequent sessions. Any current treatment for pain will continue and be recorded. Changes to analgesia during the study are not restricted and will likewise be recorded. People randomised initially to the intervention group will not subsequently undergo transfer to the TAU group, as outcomes such as pain may already have been improved by the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Acceptance and commitment therapy (ACT)Patients randomised into Group 1 will begin the 8 week group first. |
| Control crossover group | Other | Behavioral: Acceptance and commitment therapy (ACT)Patients randomised into Group 2 will act as the control for the first 8 weeks and then cross over into the intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of CD according to clinical notes for a minimum of 6 months
- Moderate pain, defined as mean score ≥4/10 on both pain severity and pain interference questions the Brief Pain Inventory (BPI) - a validated cut-off to define moderate pain
- Duration of pain of at least 3 months
- No changes to CD medication made for the previous 2 months
Key exclusion criteria (6 listed)
- Diagnosis of ulcerative colitis or indeterminate colitis
- Known diagnosis of dementia/psychosis or expressing active suicidal ideation on clinical assessment
- Currently undergoing other psychological therapy
- Primary source of pain is non-abdominal
- Non-fluency in verbal English
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 |
|---|---|---|
| Acceptance and commitment therapy (ACT)8 weekly 2 hour sessions of ACT group for CD patients with chronic pain. Manual available on request | Behavioural | Control crossover group, Intervention arm |
Primary outcome
recruitment rate
Time frame: Through study completion, an average of 24 weeks
Do patients want to be recruited/ randomised into the study
retention rate
Time frame: Through study completion, an average of 24 weeks
once randomised, do patients continue to engage in the study
completion rate
Time frame: Through study completion, an average of 24 weeks
How many patients "complete" the intervention (Attend 5 or more sessions)
10 secondary outcomes
Pain severity
Time frame: Screening, Baseline, Week 8, and 24 after randomisation
The UK Inflammatory Bowel Disease Quality of Life Questionnaire
Time frame: Baseline, Week 8, and 24 after randomisation
The Inflammatory Bowel Disease-Fatigue questionnaire
Time frame: Baseline, Week 8, and 24 after randomisation
Depression, stress and anxiety:
Time frame: Baseline, Week 8, and 24 after randomisation
Pain Acceptance
Time frame: Baseline, Week 8, and 24 after randomisation
IBD-Distress
Time frame: Baseline, Week 8, and 24 after randomisation
Treatment evaluation
Time frame: Post treatment Week 8, or 24
Impairment in functioning:.
Time frame: Baseline, Week 8, and 24 after randomisation
Pain Interference
Time frame: Screening, Baseline, Week 8, and 24 after randomisation
SIMPLE INDEX OF CROHN'S DISEASE ACTIVITY (Harvey & Bradshaw 1980)
Time frame: Screening, Baseline, Week 8, and 24 after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- 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.
Dr Wladyslawa Czuber-Dochan principal investigator
KCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy (ACT) in people with Chronic Pain and Crohn Disease, run by King's College London at 1 site 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 4 inclusion and 6 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 18 Jan 2023. 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 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?
Contact Natalie Watson (0207848 3531, Natalie.1.watson@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rate (time frame: Through study completion, an average of 24 weeks). 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?
On the ClinicalTrials.gov record for NCT05418062, which also lists 1 linked publication.
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 18 Jan 2023.