Bilateral Brain Stimulation in Trauma Therapy

NCT ID: NCT03086083

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-21

Study Completion Date

2015-08-28

Brief Summary

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Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR) bilateral brain stimulation in trauma therapy.

A randomized, parallel, before-after, blind study was performed.

Detailed Description

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Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR) bilateral brain stimulation in trauma therapy.

A randomized, parallel, before-after, blind study was performed. Thirty nine subjects were randomly distributed to two groups: one session of EMDR psychotherapy standard and other with EMDR standard protocol without its typical brain bilateral stimulation. The results of the Beck scales for anxiety, depression and hopelessness and the impact of events test were compared between groups.

Conditions

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Intervention Study Handling (Psychology)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, parallel, before-after, blind study was performed. Thirty nine subjects were randomly distributed to two groups: one session of EMDR psychotherapy standard and other with EMDR standard protocol without its typical brain bilateral stimulation. The results of the Beck scales for anxiety, depression and hopelessness and the impact of events test were compared between groups.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
All participants was invited to one session of brief Psychotherapy with a new model.

To the outcome assessor was said to study if was significant difference between those data from two groups α e β.

Study Groups

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EMDR standard protocol

Standard EMDR protocol, once.

Group Type EXPERIMENTAL

EMDR standard protocol

Intervention Type BEHAVIORAL

Patient have only one standard EMDR session about a traumatic situation remembered by him.

protocol without brain stimulation

Standard EMDR protocol without brain stimulation, once

Group Type ACTIVE_COMPARATOR

protocol without brain stimulation

Intervention Type BEHAVIORAL

Patient have only one standard EMDR session about a traumatic situation remembered by him, however, without the bilateral brain stimulation.

Interventions

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EMDR standard protocol

Patient have only one standard EMDR session about a traumatic situation remembered by him.

Intervention Type BEHAVIORAL

protocol without brain stimulation

Patient have only one standard EMDR session about a traumatic situation remembered by him, however, without the bilateral brain stimulation.

Intervention Type BEHAVIORAL

Other Intervention Names

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EMDR altered protocol

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* Inclusion criteria for the study were to be a university student, over 18 years old, to have a complaint associated to a traumatic life event and to have accepted to participate of the study.

Exclusion Criteria:

* Exclusion criteria were the existence of untreated psychiatric disorders and the hypothesis of worsening of the subject's status as the number of sessions in this study was restricted to once.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role collaborator

Ciclo de Mutação

OTHER

Sponsor Role lead

Responsible Party

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Maria Aparecida Junqueira Zampieri

Clinical Supervisor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Aparecida J Zampieri, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ciclo de Mutação

Marina J Zampieri, Graduate

Role: STUDY_CHAIR

Ciclo de Mutação

Alexandre J Zampieri, Graduate

Role: STUDY_CHAIR

Ciclo de Mutação

Moacir F Godoy, Ph.D.

Role: STUDY_CHAIR

Sao Jose do Rio Preto Medical School

Locations

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Ciclo de Mutação: Psychotherapy and Research

São José do Rio Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Nazari H, Momeni N, Jariani M, Tarrahi MJ. Comparison of eye movement desensitization and reprocessing with citalopram in treatment of obsessive-compulsive disorder. Int J Psychiatry Clin Pract. 2011 Nov;15(4):270-4. doi: 10.3109/13651501.2011.590210. Epub 2011 Aug 3.

Reference Type RESULT
PMID: 22122001 (View on PubMed)

Shapiro F, Maxfield L. Eye Movement Desensitization and Reprocessing (EMDR): information processing in the treatment of trauma. J Clin Psychol. 2002 Aug;58(8):933-46. doi: 10.1002/jclp.10068.

Reference Type RESULT
PMID: 12115716 (View on PubMed)

Shapiro F. The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences. Perm J. 2014 Winter;18(1):71-7. doi: 10.7812/TPP/13-098.

Reference Type RESULT
PMID: 24626074 (View on PubMed)

Ronconi JM, Shiner B, Watts BV. Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. J Psychiatr Pract. 2014 Jan;20(1):25-37. doi: 10.1097/01.pra.0000442936.23457.5b.

Reference Type RESULT
PMID: 24419308 (View on PubMed)

Herkt D, Tumani V, Gron G, Kammer T, Hofmann A, Abler B. Facilitating access to emotions: neural signature of EMDR stimulation. PLoS One. 2014 Aug 28;9(8):e106350. doi: 10.1371/journal.pone.0106350. eCollection 2014.

Reference Type RESULT
PMID: 25165974 (View on PubMed)

Rimini D, Molinari F, Liboni W, Balbo M, Daro R, Viotti E, Fernandez I. Effect of Ocular Movements during Eye Movement Desensitization and Reprocessing (EMDR) Therapy: A Near-Infrared Spectroscopy Study. PLoS One. 2016 Oct 26;11(10):e0164379. doi: 10.1371/journal.pone.0164379. eCollection 2016.

Reference Type RESULT
PMID: 27783688 (View on PubMed)

Related Links

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http://www.fapesp.br/

Universidade Estadual Paulista Julio de Mesquita Filho - UNESP STAEPE - Seção Tecnica de Apoio ao Ensino, Pesquisa e Extensão Instituto de Biociências, Letras e Ciências Exatas / IBILCE / UNESP

http://www.emdria.org/

The EMDR International Association (EMDRIA) is a professional association where EMDR practitioners and EMDR researchers seek the highest standards for the clinical use of EMDR therapy.

http://www.emdr.org.br/

The EMDR Brazilian Association is a association where EMDR practitioners and EMDR researchers seek standards for the clinical use of EMDR therapy.

Other Identifiers

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0000-0002-5442-4488

Identifier Type: -

Identifier Source: org_study_id

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