Bilateral Brain Stimulation in Trauma Therapy

Intervention Study Clinical Trial

Official title:

Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086083
• Other study ID #: 0000-0002-5442-4488
• Status: Completed
• Phase: N/A
• First received: February 18, 2017
• Last updated: March 24, 2017
• Start date: October 21, 2013
• Est. completion date: August 28, 2015

Study information

• Verified date: March 2017
• Source: Ciclo de Mutação
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 28, 2015
• Est. primary completion date: March 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Handling (Psychology)
• Intervention Study

Intervention

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

Locations

Country	Name	City	State
Brazil	Ciclo de Mutação: Psychotherapy and Research	Sao Jose do Rio Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
Ciclo de Mutação	Sao Jose do Rio Preto University

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Herkt D, Tumani V, Grön 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. — View Citation

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. — View Citation

Rimini D, Molinari F, Liboni W, Balbo M, Darò 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 — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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

External Links

•   Biblioteca da Faculdade de Medicina de São Jose do Rio Preto
•   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.
•   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