Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
Primary Purpose
Neurasthenia, Chronic Pain, Chronic Headache
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Medical and Psychological treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neurasthenia focused on measuring Cost-effective, Unexplained Medical Symptoms, Frequent Attenders
Eligibility Criteria
Inclusion Criteria:
- Men or women
- Age 18 or higher
- Treated at the Functional Neurology clinic at Soroka UMC
Exclusion Criteria:
- patients with chronic illness such as cancer, dialysis patients, or any other severe identified illness
- patients who do not speak Hebrew
- bedridden patients
- Schizophrenia, dementia and other severe mental illness
Sites / Locations
- Soroka University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group for Prospective Study
No Intervention
Arm Description
Intervention: Medical and psychological treatment at the Soroka UMC "functional neurology" outpatient clinic. Treatment will be conducted by a multidisciplinary staff. Patients will undergo an initial meeting with a neurologist and afterwards will be directed to other members of the team (psychologist, physical therapist) on a case by case basis.
Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur
Outcomes
Primary Outcome Measures
Health Related Quality of Life
Changes in the Short Form 36 Health Survey (SF-36)
Secondary Outcome Measures
Cost-effectiveness
Total cost associated with healthcare due to intervention
Anxiety
Changes in the State-Trait Anxiety Inventory (STAI)
Depression
Changes in the Patient Health Questionnaire 9 (PHQ-9)
Catastrophization
Changes in the Pain Catastrophization Scale (PCS)
Locus of Control
Changes in the Health Locus of Control Survey (H-LOC)
Existence of Symptoms
Changes in the Patient Health Questionnaire 15 (PHQ-15)
Pain Symptoms and Functioning
Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)
Patient Satisfaction with Medical Care
Changes in the Low Threshold Experience Survey (LTES)
Full Information
NCT ID
NCT02141568
First Posted
May 15, 2014
Last Updated
April 3, 2019
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02141568
Brief Title
Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
Official Title
Effectiveness and Cost-Effectiveness Analysis of Mind-Body Interventions in a Multi-Disciplinary Clinic for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Low patient compliance and dropout during the period defined for the study
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to check the medical efficacy and economic benefits of multidisciplinary care in patients with unexplained medical complaints and consume medical services frequently.
Detailed Description
Background:
Somatic or "medically unexplained" symptoms and syndromes are common and are seen by physicians across almost every medical specialty. In many instances, these phenomena can cause a great deal of pain and frustration, restrict function and reduce patients' quality of life. Despite their frequency and severity, medical personnel often experience a great deal of difficulty in coping with such complaints and patients may be shuttled from specialist to specialist, often with little or no symptomatic relief and at a great deal of expense to the medical system. Many researchers now believe that these seemingly unrelated and "unexplained" conditions in fact share common psycho-physiological mechanisms, such as being catalyzed as a result of trauma or excessive stress, being mediated by the limbic system and affecting inhibitory sensory pathways.
Purpose of the study:
Testing the efficacy and cost-efficiency of a holistic multidisciplinary treatment methodology for medically unexplained symptoms (MUS).
Stages of the Study:
The study wil lbe conducted via two arms:
A reterospective study of patients attending the Functional Neurology clinic a Soroka UMC between the years 2014-2018 in which patient records will be obtained via the regional offices of Clalit Health Services and analyzed in order to learn the effects of mind-body therapies on health care utilization.
A prospective study of new patients arriving at the "functional neurology" clinic at Soroka UMC. Members of the second arm will be asked if they would be willing to participate in the study by their neurologist. Participants who have agreed to join the study will fill out Self-report measures at the beginning of their treatment, at the end of treatment (3 months) and 6 months after the start of treatment and 12 months after the start of treatment.
Expected Results
A decrease in expense rates and use of medical services
An increase in patient satisfaction
An increase in patient-reported health and quality of life
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurasthenia, Chronic Pain, Chronic Headache
Keywords
Cost-effective, Unexplained Medical Symptoms, Frequent Attenders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group for Prospective Study
Arm Type
Experimental
Arm Description
Intervention: Medical and psychological treatment at the Soroka UMC "functional neurology" outpatient clinic. Treatment will be conducted by a multidisciplinary staff. Patients will undergo an initial meeting with a neurologist and afterwards will be directed to other members of the team (psychologist, physical therapist) on a case by case basis.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur
Intervention Type
Other
Intervention Name(s)
Medical and Psychological treatment
Intervention Description
Medical and psychological treatment by the staff of the "functional neurology" clinic at Soroka UMC. This treatment will include an initial visit to the staff neurologist and further multidisciplinary treatment as per his decision (the team includes a psychologist and a physical therapist).
Primary Outcome Measure Information:
Title
Health Related Quality of Life
Description
Changes in the Short Form 36 Health Survey (SF-36)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
Total cost associated with healthcare due to intervention
Time Frame
12 months
Title
Anxiety
Description
Changes in the State-Trait Anxiety Inventory (STAI)
Time Frame
6 months
Title
Depression
Description
Changes in the Patient Health Questionnaire 9 (PHQ-9)
Time Frame
6 months
Title
Catastrophization
Description
Changes in the Pain Catastrophization Scale (PCS)
Time Frame
6 months
Title
Locus of Control
Description
Changes in the Health Locus of Control Survey (H-LOC)
Time Frame
6 months
Title
Existence of Symptoms
Description
Changes in the Patient Health Questionnaire 15 (PHQ-15)
Time Frame
6 months
Title
Pain Symptoms and Functioning
Description
Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)
Time Frame
6 months
Title
Patient Satisfaction with Medical Care
Description
Changes in the Low Threshold Experience Survey (LTES)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women
Age 18 or higher
Treated at the Functional Neurology clinic at Soroka UMC
Exclusion Criteria:
patients with chronic illness such as cancer, dialysis patients, or any other severe identified illness
patients who do not speak Hebrew
bedridden patients
Schizophrenia, dementia and other severe mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yacov Ezra, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Be'er-Sheva
ZIP/Postal Code
84101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
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