Bilateral Brain Stimulation in Trauma Therapy

March 24, 2017 updated by: Maria Aparecida Junqueira Zampieri, Ciclo de Mutação

Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Jose do Rio Preto, SP, Brazil, 15020-070
        • Ciclo de Mutação: Psychotherapy and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMDR standard protocol
Standard EMDR protocol, once.
Behavioral: EMDR standard protocol
Patient have only one standard EMDR session about a traumatic situation remembered by him.
Active Comparator: protocol without brain stimulation
Standard EMDR protocol without brain stimulation, once
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.
Other Names:
  • EMDR altered protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Events Test
Time Frame: Before and immediately after the psychotherapy session, which has average of 1:30 hours.
Self-administered questionnaire to measure Impact of the traumatic event, which the patient have selected for this intervention
Before and immediately after the psychotherapy session, which has average of 1:30 hours.
Beck scale for anxiety
Time Frame: Before and immediately after the psychotherapy session, which has average of 1:30 hours.
Self-administered questionnaire to measure anxiety, in this case, when the patient are thinking about that specific traumatic event, which he or she selected for this intervention.
Before and immediately after the psychotherapy session, which has average of 1:30 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Beck scale for depression at the final of session
Time Frame: Before and immediately after the conclusion of the session, which has average of 1:30 hours
Self-administered questionnaire to measure depression, in this case, when the patient are thinking about that specific traumatic event, which he or she select for this intervention.
Before and immediately after the conclusion of the session, which has average of 1:30 hours
Change from baseline Beck scale for hopelessness at the final of session
Time Frame: Before and immediately after the conclusion of the session, which has average of 1:30 hours
Self-administered questionnaire to measure hopelessness
Before and immediately after the conclusion of the session, which has average of 1:30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciclo de Mutação

Collaborators

Sao Jose do Rio Preto Medical School

Investigators

  • Principal Investigator: Maria Aparecida J Zampieri, Ph.D., Ciclo de Mutação
  • Study Chair: Marina J Zampieri, Graduate, Ciclo de Mutação
  • Study Chair: Alexandre J Zampieri, Graduate, Ciclo de Mutação
  • Study Chair: Moacir F Godoy, Ph.D., Sao Jose do Rio Preto Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2013

Primary Completion (Actual)

March 13, 2015

Study Completion (Actual)

August 28, 2015

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0000-0002-5442-4488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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