NCT04252729

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 21, 2020

Last Update Submit

January 30, 2020

Conditions

Syncope

Keywords

PsychotherapySyncopeQuality of lifePsychoanalytic psychosomatics

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Demographic data

    12 months

  • Number of comorbidities

    12 months

  • Use of concomitant medication

    12 months

Study Arms (2)

Psychotherapy

EXPERIMENTAL

Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days.

Procedure: Psychotherapy

No psychotherapy

NO INTERVENTION

Follow-up according to institutional routine, without psychotherapy sessions.

Interventions

PsychotherapyPROCEDURE

Psychotherapy sessions based on Psychoanalytic Psychosomatics

Psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
  • Signed Free and Informed Consent Form

You may not qualify if:

  • Severe comorbidity with life expectancy \<1 year
  • Age \<18 years
  • Current psychotherapeutic follow-up
  • Cardiac or neurological syncope
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (1)

  • de Barros E Silva RLA, Volich RM, de Barros E Silva PGM, da Costa Darrieux FC, Scanavacca MI, Hachul DT. Effect of psychotherapy on recurrence of events and quality of life in patients with vasovagal syncope. Sci Rep. 2022 Apr 6;12(1):5745. doi: 10.1038/s41598-022-09513-1.

    PMID: 35388029DERIVED

MeSH Terms

Conditions

Syncope

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Arrhythmia Clinical Unit Director

Study Record Dates

First Submitted

January 21, 2020

First Posted

February 5, 2020

Study Start

July 27, 2017

Primary Completion

August 3, 2018

Study Completion

August 23, 2018

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)