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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05121922
Other study ID # IL001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2021
Est. completion date June 30, 2025

Study information

Verified date November 2022
Source University of Oslo
Contact Ingunn Leeber, MD
Phone +47 936 10 535
Email ingunnleeber@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 30, 2025
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - MUPS: Medically Unexplained Physical Symptoms - somatic and mental examination sufficiently accomplished - ongoing symptoms - more than three months of disabeling symptoms Exclusion Criteria: - not capable to respond on a written questionnaire in Norwegian

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Metacognitive Therapy
Psychological treatment provided by the patient's regular general practitioner

Locations

Country Name City State
Norway University of Oslo Oslo

Sponsors (1)

Lead Sponsor Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility in daily practice The physicians will record the number of patients that agree to participate and complete the treatment One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
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