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RecruitingNCT05121922Updated Nov 9, 2022

Sense of Coherence and Empowerment at Patients With MUPS

An interventional study of Metacognitive Therapy in Medically Unexplained Symptoms and Sense of Coherence, sponsored by University of Oslo. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by University of Oslo · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2023, 3 years 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Medically Unexplained Symptoms
  • Sense of Coherence
03

In context

Medically Unexplained Symptoms

71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.

This study's planned enrollment of 30 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.

Browse Medically Unexplained Symptoms studies →

Lead sponsor

University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • MUPS: Medically Unexplained Physical Symptoms
  • somatic and mental examination sufficiently accomplished
  • ongoing symptoms
  • more than three months of disabeling symptoms

Exclusion criteria

Exclusion Criteria:

  • not capable to respond on a written questionnaire in Norwegian
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention

    All patients recieve active treatment

    Behavioral: Metacognitive Therapy

Interventions

  • BehavioralMetacognitive Therapy

    Psychological treatment provided by the patient's regular general practitioner

06

What researchers measure

Primary outcomes

  1. Feasibility in daily practice

    The physicians will record the number of patients that agree to participate and complete the treatment

    Time frame: One year

Secondary outcomes

  1. 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.

    Time frame: One year

  2. 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.

    Time frame: One year

  3. 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.

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2021 (actual). Primary completion is estimated for Jun 2023, 22 months after the start.

Of 33 non-industry interventional studies with no phase under Medically Unexplained Symptoms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 22 months is below that.

Counting every sponsor, half of 33 studies reached it within 29 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2021
First posted
Nov 16, 2021
StartActual
Aug 15, 2021
Primary completionEst.
Jun 30, 2023
CompletionEst.
Jun 30, 2025
Last update
Nov 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05121922
Lead sponsor
University of Oslo
Responsible party
Erik L Werner (Professor, University of Oslo) — Principal investigator
First posted
Nov 16, 2021
Start date
Aug 15, 2021
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Nov 9, 2022

Study contacts

Ingunn Leeber, MD
Contact
ingunnleeber@gmail.com
+47 936 10 535
Erik L. Werner, PhD
Contact
e.l.werner@medisin.uio.no
+47 91768413
Jørund Straand, PhD
study chair · University of Oslo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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