Medical Unexplained Physical Symptoms (MUPS)ICITNCT05128019
Use of the Individual Challenge Inventory Tool (ICIT) by General Practitioners
A study testing ICIT in people with Medical Unexplained Physical Symptoms (MUPS) and Subjective Health Complaint, run by University of Oslo at 1 site in Norway.
Trial summary
Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Medical Unexplained Physical Symptoms (MUPS), Subjective Health Complaint
- What is being tested?
- ICIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteNorway
- Study dates
- 7 Mar 2022to 28 Feb 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a condition the GP deems as MUPS (unspecific og generalized pain, fatigue or mood disturbances without being depressed)
- Patients must be deemed satisfactory clinical examined without specific findings
- Patients must be able to speak and understand Norwegian language without interpreter
- Patients must sign on a consignment form
Who cannot join
- Patients must not have any well defined psychiatric diagnosis
- Patients must not have any alcohol or drug abuse
- Patients must not be using more than 10 mg Benzodiasepine per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Use of the Conversation Tool Individual Challenge Inventory Tool (ICIT) by General Practitioners Increase Coping of the Patients?
Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). They also produce a lot of unnecessary investigations and are overrepresented on sick-listing. The conversational tool Individual Challenge Inventory Tool (ICIT) offers an aid for the GPS to the consultation and aims to increase the patients' coping abilities with their health challenges. The aim of the study is to investigate whether patients experience such increased coping following a session of consultations with their GP based on ICIT.
Read the detailed description
The study is a Cluster Randomized Controlled Trial (cRCT) with GPs as clusters. We plan to includ 50 GPs to participate as intervention group and 50 GPs as controls. Each cluster will include 10 patients. GPs in the intervention group will be trained in the use of ICIT through a 30 hours course, partly digital and partly in presence. The participants will receive lectures on the background for the conversation tool, and the study, and will practice on each other. At the end of the study, also the 50 GPs of the control group will be invited to an identical course.
The outcome of the study is any changes of the patients coping abilities. If the symptoms cannot be healed, a goal for the patients will be to reduce the impact of the symptoms. In practice, this is to reuptake normal activities, including work, in spite of pain, fatigue or mood disturbances. Through the ICIT, the patients will be challenged to look at themselves in a broader spectrum and decide for themselves which activities are possible to reuptake and making a thorough plan for doing so.
The patients will be treated by their regular GP across several meetings and they will agree on a specific plan across weeks or months to achieve their individual goal.
The patients of the GPs in the control group will represent identical medical symptoms and will be treated and followed by their GP as usual. They will, however, be informed and asked to consign to participate in the study, and will respond to the same questionnaires as the patients in the intervention group.
- Being tested
- ICIT
- Keywords
- MUPS, SHC, sick leave, Communication tool, General practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICITBehavioural
Patients in the intervention group will receive a number of consultations with their GP based on the ICIT
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will offer the patients a session of unspecified length or number of consultations, to follow the conversation tool ICIT Receives: Behavioral: ICIT |
| Control | No intervention | 50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will however, only receive standard routine care and follow-up by their GP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' assessment of personal quality of life
Patients Global Impression of Change (PGIC)
Measured: One year
Patients' experiences at the encounter
Mean change on score at the Patient Experiences Questionnaire (PEQ)
Measured: One year
Secondary outcomes (1)
The primary outcome is any change in patient's coping strategies
Mean change on score at the Patient Activation Measure (PAM) in both groups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start7 Mar 2022
- Primary completion21 May 2022
- Study completion28 Feb 2023
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 Medical Unexplained Physical Symptoms (MUPS)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster Randomized Controlled Trial with an intervention group and a control group
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik L Werner, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128019
- Sponsor's protocol ID
- NSD368367
- Acronym
- ICIT
- Status last verified
- May 2023
- First submitted
- 19 Oct 2021
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrahamsen C, Reme SE, Wangen KR, Lindbaek M, Werner EL. The effects of a structured communication tool in patients with medically unexplained physical symptoms: a cluster randomized trial. EClinicalMedicine. 2023 Oct 6;65:102262. doi: 10.1016/j.eclinm.2023.102262. eCollection 2023 Nov.
PubMed 37855023
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Use of the Conversation Tool Individual Challenge Inventory Tool (ICIT) by General Practitioners Increase Coping of the Patients?
- ClinicalTrials.gov ID
- NCT05128019
- Acronym / sponsor ID
- ICIT / NSD368367
- Keywords
- MUPS, SHC, sick leave, Communication tool, General practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 19 Nov 2021 (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.
Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). They also produce a lot of unnecessary investigations and are overrepresented on sick-listing. The conversational tool Individual Challenge Inventory Tool (ICIT) offers an aid for the GPS to the consultation and aims to increase the patients' coping abilities with their health challenges. The aim of the study is to investigate whether patients experience such increased coping following a session of consultations with their GP based on ICIT.
Detailed description
The study is a Cluster Randomized Controlled Trial (cRCT) with GPs as clusters. We plan to includ 50 GPs to participate as intervention group and 50 GPs as controls. Each cluster will include 10 patients. GPs in the intervention group will be trained in the use of ICIT through a 30 hours course, partly digital and partly in presence. The participants will receive lectures on the background for the conversation tool, and the study, and will practice on each other. At the end of the study, also the 50 GPs of the control group will be invited to an identical course.
The outcome of the study is any changes of the patients coping abilities. If the symptoms cannot be healed, a goal for the patients will be to reduce the impact of the symptoms. In practice, this is to reuptake normal activities, including work, in spite of pain, fatigue or mood disturbances. Through the ICIT, the patients will be challenged to look at themselves in a broader spectrum and decide for themselves which activities are possible to reuptake and making a thorough plan for doing so.
The patients will be treated by their regular GP across several meetings and they will agree on a specific plan across weeks or months to achieve their individual goal.
The patients of the GPs in the control group will represent identical medical symptoms and will be treated and followed by their GP as usual. They will, however, be informed and asked to consign to participate in the study, and will respond to the same questionnaires as the patients in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Controlled Trial with an intervention group and a control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ICIT50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will offer the patients a session of unspecified length or number of consultations, to follow the conversation tool ICIT |
| Control | No intervention | –50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will however, only receive standard routine care and follow-up by their GP. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have a condition the GP deems as MUPS (unspecific og generalized pain, fatigue or mood disturbances without being depressed)
- Patients must be deemed satisfactory clinical examined without specific findings
- Patients must be able to speak and understand Norwegian language without interpreter
- Patients must sign on a consignment form
Key exclusion criteria (3 listed)
- Patients must not have any well defined psychiatric diagnosis
- Patients must not have any alcohol or drug abuse
- Patients must not be using more than 10 mg Benzodiasepine per day
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 |
|---|---|---|
| ICITPatients in the intervention group will receive a number of consultations with their GP based on the ICIT | Behavioural | Intervention |
Primary outcome
Patients' assessment of personal quality of life
Time frame: One year
Patients Global Impression of Change (PGIC)
Patients' experiences at the encounter
Time frame: One year
Mean change on score at the Patient Experiences Questionnaire (PEQ)
1 secondary outcome
The primary outcome is any change in patient's coping strategies
Time frame: One year
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 17 May 2023.
- Derived from this study: PubMed 37855023Abrahamsen C, Reme SE, Wangen KR, Lindbaek M, Werner EL. The effects of a structured communication tool in patients with medically unexplained physical symptoms: a cluster randomized trial. EClinicalMedicine. 2023 Oct 6;65:102262. doi: 10.1016/j.eclinm.2023.102262. eCollection 2023 Nov.
- Individual participant dataSharing planned: No
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?
A study testing ICIT in people with Medical Unexplained Physical Symptoms (MUPS) and Subjective Health Complaint, run by University of Oslo at 1 site in Norway.
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 3 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 17 May 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 Norway. 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?
Patients' assessment of personal quality of life (time frame: One year). The study lists 2 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 NCT05128019, 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 17 May 2023.