Intervention StudyNCT03086083
Bilateral Brain Stimulation in Trauma Therapy
A study testing EMDR standard protocol and protocol without brain stimulation in people with Intervention Study and Handling (Psychology), run by Ciclo de Mutação at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention Study, Handling (Psychology)
- What is being tested?
- EMDR standard protocol and protocol without brain stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Oct 2013to 28 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ciclo de Mutação: Psychotherapy and Research
São José do Rio Preto, São Paulo, 15020-070
About this study
Official title: Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Intervention Study, Handling (Psychology)
- Being tested
- EMDR standard protocol, protocol without brain stimulation
- Keywords
- Traumatic memories, comparative study, single session, EMDR, Beck inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR standard protocolBehavioural
Patient have only one standard EMDR session about a traumatic situation remembered by him.
protocol without brain stimulationBehavioural
Also called EMDR altered protocol
Patient have only one standard EMDR session about a traumatic situation remembered by him, however, without the bilateral brain stimulation.
| Study group | Role | What they receive |
|---|---|---|
| EMDR standard protocol | Experimental | Standard EMDR protocol, once. Receives: Behavioral: EMDR standard protocol |
| protocol without brain stimulation | Active comparator | Standard EMDR protocol without brain stimulation, once Receives: Behavioral: protocol without brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Events Test
Self-administered questionnaire to measure Impact of the traumatic event, which the patient have selected for this intervention
Measured: 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.
Measured: 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
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.
Measured: 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
Measured: Before and immediately after the conclusion of the session, which has average of 1:30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start21 Oct 2013
- Primary completion13 Mar 2015
- Study completion28 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intervention StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciclo de Mutação
- Sponsor type
- University, hospital or other
- Collaborators
- Sao Jose do Rio Preto Medical School
- Responsible party
- Principal investigator, Maria Aparecida Junqueira Zampieri, Ciclo de Mutação
- Investigators
- Maria Aparecida J Zampieri, Ph.D., Principal investigator, Ciclo de MutaçãoMarina J Zampieri, Graduate, Study chair, Ciclo de MutaçãoAlexandre J Zampieri, Graduate, Study chair, Ciclo de MutaçãoMoacir F Godoy, Ph.D., Study chair, Sao Jose do Rio Preto Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086083
- Sponsor's protocol ID
- 0000-0002-5442-4488
- Status last verified
- Mar 2017
- First submitted
- 18 Feb 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22122001Shapiro 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.
PubMed 12115716Shapiro 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.
PubMed 24626074Ronconi 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.
PubMed 24419308Herkt 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.
PubMed 25165974Rimini 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.
PubMed 27783688
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03086083
- Acronym / sponsor ID
- 0000-0002-5442-4488
- Conditions
- Intervention Study, Handling (Psychology)
- Keywords
- Traumatic memories, comparative study, single session, EMDR, Beck inventory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ciclo de MutaçãoUniversity, hospital or other
- Collaborators
- Sao Jose do Rio Preto Medical School
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 13 Mar 2015 (actual)
- Study completion
- 28 Aug 2015 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMDR standard protocol | Experimental | Behavioral: EMDR standard protocolStandard EMDR protocol, once. |
| protocol without brain stimulation | Active comparator | Behavioral: protocol without brain stimulationStandard EMDR protocol without brain stimulation, once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR standard protocolPatient have only one standard EMDR session about a traumatic situation remembered by him. | Behavioural | EMDR standard protocol |
| protocol without brain stimulationAlso: EMDR altered protocolPatient have only one standard EMDR session about a traumatic situation remembered by him, however, without the bilateral brain stimulation. | Behavioural | protocol without brain stimulation |
Primary outcome
Impact of Events Test
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change from baseline Beck scale for depression at the final of session
Time frame: 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
Time frame: Before and immediately after the conclusion of the session, which has average of 1:30 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Results publication: PubMed 22122001Nazari 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.
- Results publication: PubMed 12115716Shapiro 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.
- Results publication: PubMed 24626074Shapiro 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.
- Results publication: PubMed 24419308Ronconi 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.
- Results publication: PubMed 25165974Herkt 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.
- Results publication: PubMed 27783688Rimini 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.
- 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 / UNESPLink provided by the sponsor.
- 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.Link provided by the sponsor.
- The EMDR Brazilian Association is a association where EMDR practitioners and EMDR researchers seek standards for the clinical use of EMDR therapy.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Aparecida J Zampieri, Ph.D. principal investigator
Ciclo de Mutação
Marina J Zampieri, Graduate study chair
Ciclo de Mutação
Alexandre J Zampieri, Graduate study chair
Ciclo de Mutação
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR standard protocol and protocol without brain stimulation in people with Intervention Study and Handling (Psychology), run by Ciclo de Mutação at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Events Test (time frame: Before and immediately after the psychotherapy session, which has average of 1:30 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086083, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017; AzTrials last refreshed its copy on 5 Nov 2026.