Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study

Study Overview
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Brief Summary
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Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. The impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. This study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.

Official Title
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Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study

Conditions
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Syncope

Intervention / Treatment
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* Procedure: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months) Signed Free and Informed Consent Form Exclusion Criteria: Severe comorbidity with life expectancy <1 year Age <18 years Current psychotherapeutic follow-up Cardiac or neurological syncope Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapy<br>Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days. | Procedure: Psychotherapy<br>* Psychotherapy sessions based on Psychoanalytic Psychosomatics<br>|
| No Intervention: No psychotherapy<br>Follow-up according to institutional routine, without psychotherapy sessions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life analysis performed by the Short Form 36 Instrument | Data collected at first visit | 1 week | 
| Quality of life analysis performed by the Short Form 36 Instrument | Data collected at first visit, 6 and 12 months (global assessment and by specific domains). | 6 months | 
| Quality of life analysis performed by the Short Form 36 Instrument | Data collected at 12 months (global assessment and by specific domains). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Gender, age, date of birth, race, monthly income and education level. | 12 months | 
| Number of comorbidities | Especially use of alcohol, drugs and smoking | 12 months | 
| Use of concomitant medication | Prescription medication that the participant uses. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Syncope, Quality of life, Psychoanalytic psychosomatics