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Completed

NCT Number: NCT03086083

Bilateral Brain Stimulation in Trauma Therapy

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.

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Key information

Conditions

Intervention Study Handling (Psychology)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciclo de Mutação: Psychotherapy and Research

São José do Rio Preto, São Paulo, 15020-070, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMDR standard protocol

Behavioral

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

protocol without brain stimulation

Behavioral

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Ciclo de Mutação

Other

Collaborators

  • Sao Jose do Rio Preto Medical School

Registry information

Official study title

Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2017
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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