Bilateral Brain Stimulation in Trauma Therapy

Not Applicable

Completed

• Conditions: Intervention Study; Handling (Psychology)
• Interventions: Behavioral: EMDR standard protocol; Behavioral: protocol without brain stimulation

• Registration Number: NCT03086083
• Lead Sponsor: Ciclo de Mutação

Brief Summary

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

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 Timeline

• Study Start: 2013-10-21
• Primary Completion: 2015-03-13
• Study Completion: 2015-08-28
• Study First Submitted: 2017-02-18
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMDR standard protocol	EMDR standard protocol	Standard EMDR protocol, once.
protocol without brain stimulation	protocol without brain stimulation	Standard EMDR protocol without brain stimulation, once

Primary Outcome Measures

Name	Time	Method
Impact of Events Test	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
Beck scale for anxiety	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 Outcome Measures

Name	Time	Method
Change from baseline Beck scale for hopelessness at the final of session	Before and immediately after the conclusion of the session, which has average of 1:30 hours	Self-administered questionnaire to measure hopelessness
Change from baseline Beck scale for depression at the final of session	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.

Trial Locations

Locations (1)

Ciclo de Mutação: Psychotherapy and Research; 🇧🇷 Sao Jose do Rio Preto, SP, Brazil