Bilateral Brain Stimulation in Trauma Therapy

Study Overview
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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.

Official Title
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Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial

Conditions
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Intervention Study, Handling (Psychology)

Intervention / Treatment
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* Behavioral: EMDR standard protocol
* Behavioral: protocol without brain stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMDR standard protocol<br>Standard EMDR protocol, once. | Behavioral: EMDR standard protocol<br>* Patient have only one standard EMDR session about a traumatic situation remembered by him.<br>|
| Active Comparator: protocol without brain stimulation<br>Standard EMDR protocol without brain stimulation, once | Behavioral: protocol without brain stimulation<br>* Patient have only one standard EMDR session about a traumatic situation remembered by him, however, without the bilateral brain stimulation.<br>* Other names: EMDR altered protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Events Test | 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 | 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 | 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 | Self-administered questionnaire to measure hopelessness | Before and immediately after the conclusion of the session, which has average of 1:30 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic memories, comparative study, single session, EMDR, Beck inventory