An interventional study of Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Treatment as Usual in Bipolar Disorder, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Prevention
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.
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's planned enrollment of 82 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Presence of one or more distressing traumatic events, assessed by:
Exclusion Criteria:
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.
Other: Eye Movement Desensitization and Reprocessing (EMDR) Therapy · Other: Treatment as Usual
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.
Other: Treatment as Usual
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.
Also known as: EMDR Therapy
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.
Also known as: TAU
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).
Time frame: 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).
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: Undecided
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Hospital de Clinicas de Porto Alegre