Medically Unexplained SymptomsNCT05121922
Sense of Coherence and Empowerment at Patients With MUPS
A study testing Metacognitive Therapy in people with Medically Unexplained Symptoms and Sense of Coherence, run by University of Oslo at 1 site in Norway.
Trial summary
This is a study on Metacognitive therapy in general practice in Norway. The intervention is a small pilot study to examine whether Metacognitive therapy is feasible in an ordinary general practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medically Unexplained Symptoms, Sense of Coherence
- What is being tested?
- Metacognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2021to 30 Jun 2025
- 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
- MUPS: Medically Unexplained Physical Symptoms
- somatic and mental examination sufficiently accomplished
- ongoing symptoms
- more than three months of disabeling symptoms
Who cannot join
- not capable to respond on a written questionnaire in Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
University of Oslo
Oslo
Erik L Werner, PhD, +4722850592, e.l.werner@medisin.uio.no
About this study
Official title: Sense of Coherence and Empowerment at Patients With Medically Unexplained Physical Symptoms in General Practice
This is a study on Metacognitive therapy in general practice in Norway. The intervention is a small pilot study to examine whether Metacognitive therapy is feasible in an ordinary general practice. Will the physicians be capable to learn and provide the therapy method for their patients with MUPS and is is possible to implement this in an ordinary general practice routine? Both physicians and their patients will be asked to respond to a questionnaire on perceived utility of the treatment.
Read the detailed description
Metacognitive therapy is different from Cognitive therapy in the sense that it adresses the individual's attention towards potential worries and threats and also the management performed by the patient to avoid these. Also the individual's capacity to produce empowerment to manage these threats are of interest in the talks with the health care provider. - In this study, General Practitioners with specific training in Metacognitive therapy will be asked to recruit 2-3 patients with Medically Unexplained Physical Symptoms each and invite them to a series of Metacognitive Therapy. The patients and physicians will then provide their assessments of the treatment on a number of questionnaires. To explore the Sense of coherence and Empowerment among patients with Medically Unexplained Symptoms, the physicians will be asked to recruit six patients each to respond to a questionnaire.
- Conditions
- Medically Unexplained Symptoms, Sense of Coherence
- Being tested
- Metacognitive Therapy
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyBehavioural
Psychological treatment provided by the patient's regular general practitioner
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients recieve active treatment Receives: Behavioral: Metacognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in daily practice
The physicians will record the number of patients that agree to participate and complete the treatment
Measured: One year
Secondary outcomes (3)
Effect of metacognitive therapy
Participating patients will respond on The Cognitive Attentional Syndrome Questionnaire (CAS-1) following each treatment session. A reduced score indicates improvement of symptom burden.
Measured: One year
Effect of metacognitive therapy
Participating patients will respond on The Sense of Coherence Questionnaire (SOC-29) at start and at the end of the treatment. A reduced score indicates improvement of symptom burden.
Measured: One year
Effect of metacognitive therapy
Participating patients will respond on The Short Form Health Survey RAND-36 at start and at the end of the treatment. A reduced score indicates improvement of symptom burden.
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 posted16 Nov 2021
- Study start15 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medically Unexplained SymptomsStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik L Werner, University of Oslo
- Investigators
- Jørund Straand, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121922
- Sponsor's protocol ID
- IL001
- Status last verified
- Nov 2022
- First submitted
- 19 Oct 2021
- Last updated
- 9 Nov 2022
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sense of Coherence and Empowerment at Patients With Medically Unexplained Physical Symptoms in General Practice
- ClinicalTrials.gov ID
- NCT05121922
- Acronym / sponsor ID
- IL001
- Conditions
- Medically Unexplained Symptoms, Sense of Coherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 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.
This is a study on Metacognitive therapy in general practice in Norway. The intervention is a small pilot study to examine whether Metacognitive therapy is feasible in an ordinary general practice. Will the physicians be capable to learn and provide the therapy method for their patients with MUPS and is is possible to implement this in an ordinary general practice routine? Both physicians and their patients will be asked to respond to a questionnaire on perceived utility of the treatment.
Detailed description
Metacognitive therapy is different from Cognitive therapy in the sense that it adresses the individual's attention towards potential worries and threats and also the management performed by the patient to avoid these. Also the individual's capacity to produce empowerment to manage these threats are of interest in the talks with the health care provider. - In this study, General Practitioners with specific training in Metacognitive therapy will be asked to recruit 2-3 patients with Medically Unexplained Physical Symptoms each and invite them to a series of Metacognitive Therapy. The patients and physicians will then provide their assessments of the treatment on a number of questionnaires. To explore the Sense of coherence and Empowerment among patients with Medically Unexplained Symptoms, the physicians will be asked to recruit six patients each to respond to a questionnaire.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Metacognitive TherapyAll patients recieve active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MUPS: Medically Unexplained Physical Symptoms
- somatic and mental examination sufficiently accomplished
- ongoing symptoms
- more than three months of disabeling symptoms
Key exclusion criteria (1 listed)
- not capable to respond on a written questionnaire in Norwegian
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 |
|---|---|---|
| Metacognitive TherapyPsychological treatment provided by the patient's regular general practitioner | Behavioural | Intervention |
Primary outcome
Feasibility in daily practice
Time frame: One year
The physicians will record the number of patients that agree to participate and complete the treatment
3 secondary outcomes
Effect of metacognitive therapy
Time frame: One year
Effect of metacognitive therapy
Time frame: One year
Effect of metacognitive therapy
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- 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.
Jørund Straand, PhD study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Therapy in people with Medically Unexplained Symptoms and Sense of Coherence, 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 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingunn Leeber, MD (+47 936 10 535, ingunnleeber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in daily practice (time frame: One year). 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 9 Nov 2022.