Sense of Coherence and Empowerment at Patients With MUPS

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.

Study Overview

• Status: Recruiting
• Conditions: Medically Unexplained Symptoms; Sense of Coherence
• Intervention / Treatment: Behavioral: Metacognitive Therapy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingunn Leeber, MD; Phone Number: +47 936 10 535; Email: ingunnleeber@gmail.com
• Study Contact Backup: Name: Erik L. Werner, PhD; Phone Number: +47 91768413; Email: e.l.werner@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; All patients recieve active treatment	Behavioral: Metacognitive Therapy; Psychological treatment provided by the patient's regular general practitioner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility in daily practice	The physicians will record the number of patients that agree to participate and complete the treatment	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Study Chair: Jørund Straand, PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Medically Unexplained Symptoms
• Other Study ID Numbers: IL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No