Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)

Sponsor

Soroka University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02141568

Collaborator

(none)

Enrollment

Location

Arms

37.8

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neurasthenia Chronic Pain Chronic Headache	Other: Medical and Psychological treatment	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Feb 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group for Prospective Study 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.	Other: Medical and Psychological treatment 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).
No Intervention: No Intervention Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur

Arm

Intervention/Treatment

Experimental: Intervention Group for Prospective Study

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.

Other: Medical and Psychological treatment

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).

No Intervention: No Intervention

Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur

Outcome Measures

Primary Outcome Measures

Health Related Quality of Life [6 months]
Changes in the Short Form 36 Health Survey (SF-36)

Secondary Outcome Measures

Cost-effectiveness [12 months]
Total cost associated with healthcare due to intervention
Anxiety [6 months]
Changes in the State-Trait Anxiety Inventory (STAI)
Depression [6 months]
Changes in the Patient Health Questionnaire 9 (PHQ-9)
Catastrophization [6 months]
Changes in the Pain Catastrophization Scale (PCS)
Locus of Control [6 months]
Changes in the Health Locus of Control Survey (H-LOC)
Existence of Symptoms [6 months]
Changes in the Patient Health Questionnaire 15 (PHQ-15)
Pain Symptoms and Functioning [6 months]
Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)
Patient Satisfaction with Medical Care [6 months]
Changes in the Low Threshold Experience Survey (LTES)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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