Bipolar DisorderNCT03946787
EMDR in Adolescents With Bipolar Disorder and History of Trauma
A study testing Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Treatment as Usual in people with Bipolar Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
In this research, EMDR protocol model specific for bipolar patients with a history of trauma, developed by Benedikt Ahmann et al (2017), who applies EMDR in adults with Bipolar Disorder (BD) and history of trauma will be adapted for adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Treatment as Usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Feb 2019to Jan 2020
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 12 and 17 years and 11 months;
- current clinical state of euthymia (patient stable or euthymic) after clinical evaluation, defined as the presence of clinical remission (CDRS ≤ 40, YMRS ≤ 12.5 and CGAS (Children's Global Assessment Scale) ≥ 51), being the presence of subsyndromic symptoms (YMRS> 8 and <14) admissible;
- Presence of one or more distressing traumatic events, assessed by:
- Trauma subscale of the Post Traumatic Stress Disorder Questionnaire from the Schedule for Affective Disorders and Schizophrenia for School Aged Children Present and Lifetime Version (K-SADS-PL) , with frequency> 1;
- Holmes Rahes Stress Inventory for non-adults (H-RLSI) with frequency> 1;
- Children Revised Impact of Event Scale (CRIES)> 0;
- Childhood Trauma Questionnaire (CTQ)> 0; and
- at least 5 points in the disturbance assessment by the Subjective Units of Disturbance (SUDS) scale.
Who cannot join
- substance abuse / dependence within 3 months prior to participation;
- neurological disease or history of brain trauma;
- autism;
- Intelligence Quotient <70;
- suicidal or homicidal ideation;
- prior involvement in trauma-focused therapy;
- psychotherapy during the study and months of follow-up, and;
- a score greater than 25 on the Adolescent Dissociative Experience Scale, since the presence of massive dissociation requires different and more extensive treatment protocols.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Pesquisas Clínicas do Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
Andrea Rambo, +555133598943, l-cpc-recepcao@hcpa.edu.br
Tatiana L Peruzzolo, +555133598943, tperuzzolo_pos@hcpa.edu.br
About this study
Official title: EMDR Therapy in Relapse Prevention in Mood Episodes in Adolescents With Bipolar Disorder and History of Trauma: A Randomized Clinical Trial
In this research, EMDR protocol model specific for bipolar patients with a history of trauma, developed by Benedikt Ahmann et al (2017), who applies EMDR in adults with Bipolar Disorder (BD) and history of trauma will be adapted for adolescents. This protocol consists of a detailed survey of traumatic events, intervention and processing of these events according to the standard protocol developed by Shapiro.
The main hypothesis is that the use of EMDR in adolescents with BD and history of trauma, as a complement to the pharmacological treatment (Usual Treatment), would have beneficial effects in the course of the disease. Thus, the overall objective of this study is to examine whether EMDR therapy in adolescents with BD and history of traumatic events can reduce affective relapses within a 12-month period. In addition, improvement in biological markers related to BD is expected to be found when compared to the Usual Treatment. It is also expected that patients treated with EMDR will present a better neurocognitive functioning profile, assessed by means of a neuropsychological evaluation battery before and after the intervention, since recent studies show that the profile of humoral dysregulation, impulsiveness, difficulty in dealing with frustrations and social feedback in children and adolescents with BD is associated with poor cognitive control and executive function deficits.
Read the detailed description
This will be a randomized controlled trial. Participants will be assigned to Eye Movement Desensitization and Reprocessing (EMDR) Therapy or Treatment as Usual (TAU) through block randomization. This process will be done using the program available at www. randomization.com.
In this study, EMDR Therapy will be applied in adolescents with BD and compared to the Usual Treatment. The neuropsychological profile of the patients will be evaluated before and after the interventions. In addition, the collection of the biological markers related to BD will be done by measuring the levels of salivary cortisol and serum levels of C-reactive protein (CRP), Brain Derived Neurotrophic Factor (BDNF), Interleukin (IL) - 1β, IL - 2, IL - 4, IL - 6, IL - 10, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha(TNF-α) in these patients, since a study proposing the use of serological biomarkers for BD diagnosis concluded that the use of a single biomarker would be of little use and a combination of several biomarkers would be necessary.
- Conditions
- Bipolar Disorder
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR) Therapy, Treatment as Usual
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR) TherapyOther
Also called EMDR Therapy
The reprocessing and desensitization of each traumatic memory occurs in eight phases. In the first two phases, the therapist identifies targets and develops a treatment plan, enhances and develops personal resources, before working on traumatic memories. In stages 3 to 6, reprocessing and desensitization of memory is done. The patient focuses on the image of the event, negative beliefs and associated bodily sensations, while moving the eyes from side to side, following the therapist's fingers or other dual attention stimuli (eg, manual touch, auditory stimulation). Phases 7 and 8 are closing and reassessing, where the therapist determines if the memory has been processed properly.
Treatment as UsualOther
Also called TAU
TAU will consist of the psychopharmacological approach appropriate to each patient according to the evaluation of a psychiatrist of childhood and adolescence's outpatient service.
| Study group | Role | What they receive |
|---|---|---|
| EMDR Therapy + TAU | Active comparator | Patients will be submitted to 20 individual sessions of Eye Movement Desensitization and Reprocessing (EMDR) Therapy of 60 minutes each, combined to the Treatment as usual (TAU).
It's an eight-step process aimed at the traumatic events, also used to address current situations that evoke emotional disturbances so they do not trigger more symptomatic reactions. In addition, it is helpful to assist the patient in developing the specific skills and behaviors required for a healthy functional life.
Our group will adapt the EMDR protocol model specific for bipolar patients with a history of trauma, developed by Ahmann et al (2017), who applies EMDR in adults with Bipolar Disorder (BD) and history of trauma. Receives: Other: Eye Movement Desensitization and Reprocessing (EMDR) Therapy; Other: Treatment as Usual |
| TAU (Treatment as Usual) | Placebo comparator | Patients will receive the Treatment as Usual. TAU will consist of the psychopharmacological approach appropriate to each patient according to the evaluation of a psychiatrist of childhood and adolescence's outpatient service. Patients are expected to be euthymic (or with subsyndromal symptoms) with the same medication for at least 3 months.
Although the medications used by patients are relevant and taken into account in future analyzes, our group will not interfere with drug treatment. Thus, patients who require any type of drug intervention will be considered losses. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of manic switches.
To verify if treatment with EMDR leads to a reduction in the number of manic episodes within a period of 12 months.This will be evaluated through the Young Mania Rating Scale (YMRS).
Measured: 12 months
Reduction in the number of depressive episodes
To verify if treatment with EMDR leads to a reduction in the number of depressive episodes within a period of 12 months.This will be evaluated through the Children's Depression Rating Scale (CDRS).
Measured: 12 months
Secondary outcomes (35)
Change in biological markers measured by morning salivary cortisol levels in 6 months
To analyze the biological markers related to BD, through the measurement of morning salivary cortisol levels.
Measured: 6 months
Change in biological markers measured by morning salivary cortisol levels in 12 months
To analyze the biological markers related to BD, through the measurement of morning salivary cortisol levels.
Measured: 12 months
Change in biological markers measured by C-reactive protein levels in 6 months.
To analyze the biological markers related to BD, through the measurement of C-reactive protein levels.
Measured: 6 months
Change in biological markers measured by C-reactive protein levels in 12 months.
To analyze the biological markers related to BD, through the measurement of C-reactive protein levels.
Measured: 12 months
Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Brain Derived Neurotrophic Factor levels.
Measured: 6 months
Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Brain Derived Neurotrophic Factor levels.
Measured: 12 months
Change in biological markers measured by Interleukin-1 Beta levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-1 Beta levels.
Measured: 6 months
Change in biological markers measured by Interleukin-1 Beta levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-1 Beta levels.
Measured: 12 months
Change in biological markers measured by Interleukin-2 levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-2 levels.
Measured: 6 months
Change in biological markers measured by Interleukin-2 levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-2 levels.
Measured: 12 months
Change in biological markers measured by Interleukin-4 levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-4 levels.
Measured: 6 months
Change in biological markers measured by Interleukin-4 levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-4 levels.
Measured: 12 months
Improvement in biological markers measured by Interleukin-6 levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-6 levels.
Measured: 6 months
Change in biological markers measured by Interleukin-6 levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-6 levels.
Measured: 12 months
Change in biological markers measured by Interleukin-10 levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-10 levels.
Measured: 6 months
Change in biological markers measured by Interleukin-10 levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Interleukin-10 levels.
Measured: 12 months
Change in biological markers measured by Interferon-gamma levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Interferon-gamma levels.
Measured: 6 months
Change in biological markers measured by Interferon-gamma levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Interferon-gamma levels.
Measured: 12 months
Change in biological markers measured by Tumor Necrosis Factor alpha levels in 6 months.
To analyze the biological markers related to BD, through the measurement of Tumor Necrosis Factor alpha levels.
Measured: 6 months
Change in biological markers measured by Tumor Necrosis Factor alpha levels in 12 months.
To analyze the biological markers related to BD, through the measurement of Tumor Necrosis Factor alpha levels.
Measured: 12 months
Modification in neurocognitive functioning through the WASI test.
To verify if the patients treated with EMDR will present a better profile of neurocognitive functioning, evaluated by means of the Wechsler Abbreviated Intelligence Scale (WASI).
Measured: 12 months
Modification in neurocognitive functioning through the WISC-III test.
To verify if the patients treated with EMDR will present a better profile of neurocognitive functioning, evaluated by means of the Wechsler Intelligence Scale for Children (WISC-III) in adolescents aged up to 17 years.
Measured: 12 months
Modification in neurocognitive functioning through the WAIS-III test.
To verify if the patients treated with EMDR will present a better profile of neurocognitive functioning, evaluated by means of the Wechsler Intelligence Scale for Adults - Third Edition (WAIS-III) for adolescents over 17 years of age.
Measured: 12 months
Modification in neurocognitive functioning through the MAC Battery.
To verify if patients treated with EMDR will present an improvement in processing speed, access to semantic memory, and inhibitory control evaluated by means of the Verbal Fluency Tasks of the Montreal Communication Assessment Battery (MAC Battery).
Measured: 12 months
Modification in neurocognitive functioning through the Hayling Test.
To verify if patients treated with EMDR will show an improvement in the signs of inattention, impulsivity (inhibitory failure), processing speed, semantic memory, language and cognitive flexibility through the Hayling Test.
Measured: 12 months
Change in neurocognitive functioning through the MAC Battery Test.
To verify if patients treated with EMDR will present an improvement in short term memory, verbal work memory and inference processing through the Oral Narrative Discourse - MAC Battery test.
Measured: 12 months
Change in neurocognitive functioning through the DNE test.
To verify if patients treated with EMDR will show an improvement in Reading Comprehension through the DNE (Discurso Narrativo Escrito or Written Narrative Speech) test.
Measured: 12 months
Change in neurocognitive functioning through the NEUROPSILIN test.
Check if patients treated with EMDR will show an improvement in Sentence Writing (syntax) through the Spontaneous Sentence Writing Subtest - NEUPSILIN (Instrumento de Avaliação Neuropsicológica Breve Infantil or Child Brief Neuropsychological Assessment Instrument).
Measured: 12 months
Change in neurocognitive functioning through the evaluation of Comprehension of Written language.
To verify if patients treated with EMDR will present an improvement in Comprehension of written language through the Subtest Comprehension Writing - NEUPSILIN.
Measured: 12 months
Change in neurocognitive functioning through the evaluation of the Visuospatial Working Memory.
To verify if patients treated with EMDR will show an improvement in the Visuospatial Working Memory through the Visuospatial Working Memory Subtest - NEUPSILIN-INF.
Measured: 12 months
Change in neurocognitive functioning through the Go-no-Go Subtest.
To verify if patients treated with EMDR will show an improvement in attention and inhibitory control through the Go-no-go Subtest - NEUPSILIN-INF.
Measured: 12 months
Change in neurocognitive functioning through the Words Span in Sentences Subtest.
To verify if patients treated with EMDR will present an improvement in verbal work memory through the Words Span in Sentences Subtest.
Measured: 12 months
Change in neurocognitive functioning through the Five Digit Test.
To verify if patients treated with EMDR will present an improvement in the automatic and controlled processes of attention, inhibitory control, impulsivity, self-monitoring, cognitive flexibility through the Five Digit Test.
Measured: 12 months
Change in neurocognitive functioning through the Psychological Attention Battery.
To verify if patients treated with EMDR will show an improvement in the attention alternated, concentrated, and divided through the Psychological Attention Battery.
Measured: 12 months
Change in neurocognitive functioning through the Test of School Performance.
To verify if patients treated with EMDR will present an improvement in the school performance in writing of words in reading, writing of isolated words and arithmetic through the Test of School Performance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start5 Feb 2019
- Primary completionAug 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Group A: Treatment as Usual (TAU); 2. Group B: TAU plus Eye Movement Desensitization and Reprocessing (EMDR) Therapy
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ives C Passos, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946787
- Sponsor's protocol ID
- 2018-0345
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR Therapy in Relapse Prevention in Mood Episodes in Adolescents With Bipolar Disorder and History of Trauma: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03946787
- Acronym / sponsor ID
- 2018-0345
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 May 2019 (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.
In this research, EMDR protocol model specific for bipolar patients with a history of trauma, developed by Benedikt Ahmann et al (2017), who applies EMDR in adults with Bipolar Disorder (BD) and history of trauma will be adapted for adolescents. This protocol consists of a detailed survey of traumatic events, intervention and processing of these events according to the standard protocol developed by Shapiro.
The main hypothesis is that the use of EMDR in adolescents with BD and history of trauma, as a complement to the pharmacological treatment (Usual Treatment), would have beneficial effects in the course of the disease. Thus, the overall objective of this study is to examine whether EMDR therapy in adolescents with BD and history of traumatic events can reduce affective relapses within a 12-month period. In addition, improvement in biological markers related to BD is expected to be found when compared to the Usual Treatment. It is also expected that patients treated with EMDR will present a better neurocognitive functioning profile, assessed by means of a neuropsychological evaluation battery before and after the intervention, since recent studies show that the profile of humoral dysregulation, impulsiveness, difficulty in dealing with frustrations and social feedback in children and adolescents with BD is associated with poor cognitive control and executive function deficits.
Detailed description
This will be a randomized controlled trial. Participants will be assigned to Eye Movement Desensitization and Reprocessing (EMDR) Therapy or Treatment as Usual (TAU) through block randomization. This process will be done using the program available at www. randomization.com.
In this study, EMDR Therapy will be applied in adolescents with BD and compared to the Usual Treatment. The neuropsychological profile of the patients will be evaluated before and after the interventions. In addition, the collection of the biological markers related to BD will be done by measuring the levels of salivary cortisol and serum levels of C-reactive protein (CRP), Brain Derived Neurotrophic Factor (BDNF), Interleukin (IL) - 1β, IL - 2, IL - 4, IL - 6, IL - 10, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha(TNF-α) in these patients, since a study proposing the use of serological biomarkers for BD diagnosis concluded that the use of a single biomarker would be of little use and a combination of several biomarkers would be necessary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Group A: Treatment as Usual (TAU); 2. Group B: TAU plus Eye Movement Desensitization and Reprocessing (EMDR) Therapy
| Arm | Type | Receives |
|---|---|---|
| EMDR Therapy + TAU | Active comparator | Other: Eye Movement Desensitization and Reprocessing (EMDR) Therapy, Other: Treatment as UsualPatients will be submitted to 20 individual sessions of Eye Movement Desensitization and Reprocessing (EMDR) Therapy of 60 minutes each, combined to the Treatment as usual (TAU). It's an eight-step process aimed at the traumatic events, also used to address current situations that evoke emotional disturbances so they do not trigger more symptomatic reactions. In addition, it is helpful to assist the patient in developing the specific skills and behaviors required for a healthy functional life. Our group will adapt the EMDR protocol model specific for bipolar patients with a history of trauma, developed by Ahmann et al (2017), who applies EMDR in adults with Bipolar Disorder (BD) and history of trauma. |
| TAU (Treatment as Usual) | Placebo comparator | Other: Treatment as UsualPatients will receive the Treatment as Usual. TAU will consist of the psychopharmacological approach appropriate to each patient according to the evaluation of a psychiatrist of childhood and adolescence's outpatient service. Patients are expected to be euthymic (or with subsyndromal symptoms) with the same medication for at least 3 months. Although the medications used by patients are relevant and taken into account in future analyzes, our group will not interfere with drug treatment. Thus, patients who require any type of drug intervention will be considered losses. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- age between 12 and 17 years and 11 months;
- current clinical state of euthymia (patient stable or euthymic) after clinical evaluation, defined as the presence of clinical remission (CDRS ≤ 40, YMRS ≤ 12.5 and CGAS (Children's Global Assessment Scale) ≥ 51), being the presence of subsyndromic symptoms (YMRS> 8 and <14) admissible;
- Presence of one or more distressing traumatic events, assessed by:
Key exclusion criteria (8 listed)
- substance abuse / dependence within 3 months prior to participation;
- neurological disease or history of brain trauma;
- autism;
- Intelligence Quotient <70;
- suicidal or homicidal ideation;
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 |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) TherapyAlso: EMDR TherapyThe reprocessing and desensitization of each traumatic memory occurs in eight phases. In the first two phases, the therapist identifies targets and develops a treatment plan, enhances and develops personal resources, before working on traumatic memories. In stages 3 to 6, reprocessing and desensitization of memory is done. The patient focuses on the image of the event, negative beliefs and associated bodily sensations, while moving the eyes from side to side, following the therapist's fingers or other dual attention stimuli (eg, manual touch, auditory stimulation). Phases 7 and 8 are closing and reassessing, where the therapist determines if the memory has been processed properly. | Other | EMDR Therapy + TAU |
| Treatment as UsualAlso: TAUTAU will consist of the psychopharmacological approach appropriate to each patient according to the evaluation of a psychiatrist of childhood and adolescence's outpatient service. | Other | EMDR Therapy + TAU, TAU (Treatment as Usual) |
Primary outcome
Reduction in the number of manic switches.
Time frame: 12 months
To verify if treatment with EMDR leads to a reduction in the number of manic episodes within a period of 12 months.This will be evaluated through the Young Mania Rating Scale (YMRS).
Reduction in the number of depressive episodes
Time frame: 12 months
To verify if treatment with EMDR leads to a reduction in the number of depressive episodes within a period of 12 months.This will be evaluated through the Children's Depression Rating Scale (CDRS).
35 secondary outcomes
Change in biological markers measured by morning salivary cortisol levels in 6 months
Time frame: 6 months
Change in biological markers measured by morning salivary cortisol levels in 12 months
Time frame: 12 months
Change in biological markers measured by C-reactive protein levels in 6 months.
Time frame: 6 months
Change in biological markers measured by C-reactive protein levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Interleukin-1 Beta levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Interleukin-1 Beta levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Interleukin-2 levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Interleukin-2 levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Interleukin-4 levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Interleukin-4 levels in 12 months.
Time frame: 12 months
Improvement in biological markers measured by Interleukin-6 levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Interleukin-6 levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Interleukin-10 levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Interleukin-10 levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Interferon-gamma levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Interferon-gamma levels in 12 months.
Time frame: 12 months
Change in biological markers measured by Tumor Necrosis Factor alpha levels in 6 months.
Time frame: 6 months
Change in biological markers measured by Tumor Necrosis Factor alpha levels in 12 months.
Time frame: 12 months
Modification in neurocognitive functioning through the WASI test.
Time frame: 12 months
Modification in neurocognitive functioning through the WISC-III test.
Time frame: 12 months
Modification in neurocognitive functioning through the WAIS-III test.
Time frame: 12 months
Modification in neurocognitive functioning through the MAC Battery.
Time frame: 12 months
Modification in neurocognitive functioning through the Hayling Test.
Time frame: 12 months
Change in neurocognitive functioning through the MAC Battery Test.
Time frame: 12 months
Change in neurocognitive functioning through the DNE test.
Time frame: 12 months
Change in neurocognitive functioning through the NEUROPSILIN test.
Time frame: 12 months
Change in neurocognitive functioning through the evaluation of Comprehension of Written language.
Time frame: 12 months
Change in neurocognitive functioning through the evaluation of the Visuospatial Working Memory.
Time frame: 12 months
Change in neurocognitive functioning through the Go-no-Go Subtest.
Time frame: 12 months
Change in neurocognitive functioning through the Words Span in Sentences Subtest.
Time frame: 12 months
Change in neurocognitive functioning through the Five Digit Test.
Time frame: 12 months
Change in neurocognitive functioning through the Psychological Attention Battery.
Time frame: 12 months
Change in neurocognitive functioning through the Test of School Performance.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ives C Passos, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Treatment as Usual in people with Bipolar Disorder, run by Hospital de Clinicas de Porto Alegre 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 May 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ives C Passos, PhD (+555133598845, ivescp1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of manic switches. (time frame: 12 months). 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?
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 13 May 2019.