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Clinical Trials/NCT02141568
NCT02141568
Terminated
N/A

Effectiveness and Cost-Effectiveness Analysis of Mind-Body Interventions in a Multi-Disciplinary Clinic for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)

Soroka University Medical Center1 site in 1 country15 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neurasthenia
Sponsor
Soroka University Medical Center
Enrollment
15
Locations
1
Primary Endpoint
Health Related Quality of Life
Status
Terminated
Last Updated
7 years ago

Overview

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: 1. 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. 2. 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 1. A decrease in expense rates and use of medical services 2. An increase in patient satisfaction 3. An increase in patient-reported health and quality of life

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 26, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Health Related Quality of Life

Time Frame: 6 months

Changes in the Short Form 36 Health Survey (SF-36)

Secondary Outcomes

  • Cost-effectiveness(12 months)
  • Locus of Control(6 months)
  • Anxiety(6 months)
  • Depression(6 months)
  • Catastrophization(6 months)
  • Existence of Symptoms(6 months)
  • Pain Symptoms and Functioning(6 months)
  • Patient Satisfaction with Medical Care(6 months)

Study Sites (1)

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