Sense of Coherence and Empowerment at Patients With MUPS

Medically Unexplained Symptoms Clinical Trial

Official title:

Sense of Coherence and Empowerment at Patients With Medically Unexplained Physical Symptoms in General Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121922
• Other study ID #: IL001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Sense of Coherence

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