Sense of Coherence and Empowerment at Patients With MUPS
Primary Purpose
Medically Unexplained Symptoms, Sense of Coherence
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Metacognitive Therapy
Sponsored by
About this trial
This is an interventional health services research trial for Medically Unexplained Symptoms
Eligibility Criteria
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
Sites / Locations
- University of OsloRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
All patients recieve active treatment
Outcomes
Primary Outcome Measures
Feasibility in daily practice
The physicians will record the number of patients that agree to participate and complete the treatment
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05121922
Brief Title
Sense of Coherence and Empowerment at Patients With MUPS
Official Title
Sense of Coherence and Empowerment at Patients With Medically Unexplained Physical Symptoms in General Practice
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medically Unexplained Symptoms, Sense of Coherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All patients recieve active treatment
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Therapy
Intervention Description
Psychological treatment provided by the patient's regular general practitioner
Primary Outcome Measure Information:
Title
Feasibility in daily practice
Description
The physicians will record the number of patients that agree to participate and complete the treatment
Time Frame
One year
Secondary Outcome Measure Information:
Title
Effect of metacognitive therapy
Description
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
Title
Effect of metacognitive therapy
Description
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
Title
Effect of metacognitive therapy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingunn Leeber, MD
Phone
+47 936 10 535
Email
ingunnleeber@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erik L. Werner, PhD
Phone
+47 91768413
Email
e.l.werner@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørund Straand, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik L Werner, PhD
Phone
+4722850592
Email
e.l.werner@medisin.uio.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Sense of Coherence and Empowerment at Patients With MUPS
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