NCT05121922

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

October 19, 2021

Last Update Submit

November 8, 2022

Conditions

Medically Unexplained SymptomsSense of Coherence

Outcome Measures

Primary Outcomes (1)

  • Feasibility in daily practice

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

    One year

Secondary Outcomes (3)

  • Effect of metacognitive therapy

    One year

  • Effect of metacognitive therapy

    One year

  • Effect of metacognitive therapy

    One year

Study Arms (1)

Intervention

EXPERIMENTAL

All patients recieve active treatment

Behavioral: Metacognitive Therapy

Interventions

Metacognitive TherapyBEHAVIORAL

Psychological treatment provided by the patient's regular general practitioner

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not capable to respond on a written questionnaire in Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jørund Straand, PhD

    University of Oslo

    STUDY CHAIR

Central Study Contacts

Ingunn Leeber, MD

CONTACT

+47 936 10 535ingunnleeber@gmail.com

Erik L. Werner, PhD

CONTACT

+47 91768413e.l.werner@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 16, 2021

Study Start

August 15, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2025

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)