NCT03086083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

February 18, 2017

Last Update Submit

March 24, 2017

Conditions

Intervention StudyHandling (Psychology)

Keywords

Traumatic memoriescomparative studysingle sessionEMDRBeck inventory

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (2)

EMDR standard protocol

EXPERIMENTAL

Standard EMDR protocol, once.

Behavioral: EMDR standard protocol

protocol without brain stimulation

ACTIVE COMPARATOR

Standard EMDR protocol without brain stimulation, once

Behavioral: protocol without brain stimulation

Interventions

EMDR standard protocolBEHAVIORAL

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

EMDR standard protocol
protocol without brain stimulationBEHAVIORAL

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

Also known as: EMDR altered protocol
protocol without brain stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ciclo de Mutação: Psychotherapy and Research

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

Location

Related Publications (6)

  • 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.

    PMID: 22122001RESULT

  • 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.

    PMID: 12115716RESULT

  • 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.

    PMID: 24626074RESULT

  • 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.

    PMID: 24419308RESULT

  • 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.

    PMID: 25165974RESULT

  • 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.

    PMID: 27783688RESULT

Related Links

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Maria Aparecida J Zampieri, Ph.D.

    Ciclo de Mutação

    PRINCIPAL INVESTIGATOR

  • Marina J Zampieri, Graduate

    Ciclo de Mutação

    STUDY CHAIR

  • Alexandre J Zampieri, Graduate

    Ciclo de Mutação

    STUDY CHAIR

  • Moacir F Godoy, Ph.D.

    Sao Jose do Rio Preto Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
All participants was invited to one session of brief Psychotherapy with a new model. To the outcome assessor was said to study if was significant difference between those data from two groups α e β.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Supervisor, Principal Investigator

Study Record Dates

First Submitted

February 18, 2017

First Posted

March 22, 2017

Study Start

October 21, 2013

Primary Completion

March 13, 2015

Study Completion

August 28, 2015

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)