Clinical trial NCT03086083: Bilateral Brain Stimulation in Trauma Therapy
Official title: Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention Study
Handling (Psychology)
Keywords: Traumatic memories
comparative study
single session
EMDR
Beck inventory
Lead sponsor: Ciclo de Mutação
Sponsor class: OTHER
Collaborators: name: Sao Jose do Rio Preto Medical School
First posted: 2017-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of Events Test
timeFrame: Before and immediately after the psychotherapy session, which has average of 1:30 hours.
measure: Beck scale for anxiety
timeFrame: Before and immediately after the psychotherapy session, which has average of 1:30 hours.
Secondary outcomes:
measure: Change from baseline Beck scale for depression at the final of session
timeFrame: Before and immediately after the conclusion of the session, which has average of 1:30 hours
measure: Change from baseline Beck scale for hopelessness at the final of session
timeFrame: Before and immediately after the conclusion of the session, which has average of 1:30 hours
Other outcomes:
Locations:
city: Sao Jose do Rio Preto
country: Brazil
facility: Ciclo de Mutação: Psychotherapy and Research
state: SP
Study officials:
affiliation: Ciclo de Mutação
name: Maria Aparecida J Zampieri, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ciclo de Mutação
name: Marina J Zampieri, Graduate
role: STUDY_CHAIR
affiliation: Ciclo de Mutação
name: Alexandre J Zampieri, Graduate
role: STUDY_CHAIR
affiliation: Sao Jose do Rio Preto Medical School
name: Moacir F Godoy, Ph.D.
role: STUDY_CHAIR
References:
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. Epub 2011 Aug 3.
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. doi: 10.1002/jclp.10068.
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.
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.
citation: Herkt D, Tumani V, Gron 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. eCollection 2014.
citation: Rimini D, Molinari F, Liboni W, Balbo M, Daro 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/journal.pone.0164379. eCollection 2016.