EMDR Therapy in Relapse Prevention in Mood Episodes in Adolescents With Bipolar Disorder and History of Trauma: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Reduction in the number of manic switches.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •substance abuse / dependence within 3 months prior to participation;
- •neurological disease or history of brain trauma;
- •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.
研究组 & 干预措施
EMDR Therapy + TAU
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.
干预措施: Treatment as Usual (Other)
TAU (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.
干预措施: Treatment as Usual (Other)
EMDR Therapy + TAU
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.
干预措施: Eye Movement Desensitization and Reprocessing (EMDR) Therapy (Other)
结局指标
主要结局
Reduction in the number of manic switches.
时间窗: 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
时间窗: 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).
次要结局
- Change in biological markers measured by C-reactive protein levels in 6 months.(6 months)
- Change in biological markers measured by Interleukin-2 levels in 6 months.(6 months)
- Change in biological markers measured by Interleukin-6 levels in 12 months.(12 months)
- Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 12 months.(12 months)
- Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 6 months.(6 months)
- Change in biological markers measured by morning salivary cortisol levels in 12 months(12 months)
- Change in biological markers measured by Interleukin-1 Beta levels in 6 months.(6 months)
- Change in biological markers measured by Interferon-gamma levels in 6 months.(6 months)
- Change in biological markers measured by Tumor Necrosis Factor alpha levels in 12 months.(12 months)
- Change in biological markers measured by morning salivary cortisol levels in 6 months(6 months)
- Change in biological markers measured by C-reactive protein levels in 12 months.(12 months)
- Change in biological markers measured by Interleukin-2 levels in 12 months.(12 months)
- Change in biological markers measured by Interleukin-4 levels in 6 months.(6 months)
- Improvement in biological markers measured by Interleukin-6 levels in 6 months.(6 months)
- Modification in neurocognitive functioning through the MAC Battery.(12 months)
- Modification in neurocognitive functioning through the Hayling Test.(12 months)
- Change in neurocognitive functioning through the DNE test.(12 months)
- Change in neurocognitive functioning through the Test of School Performance.(12 months)
- Change in biological markers measured by Interleukin-1 Beta levels in 12 months.(12 months)
- Change in biological markers measured by Interleukin-10 levels in 6 months.(6 months)
- Change in biological markers measured by Interferon-gamma levels in 12 months.(12 months)
- Change in biological markers measured by Tumor Necrosis Factor alpha levels in 6 months.(6 months)
- Change in biological markers measured by Interleukin-4 levels in 12 months.(12 months)
- Change in biological markers measured by Interleukin-10 levels in 12 months.(12 months)
- Modification in neurocognitive functioning through the WASI test.(12 months)
- Modification in neurocognitive functioning through the WISC-III test.(12 months)
- Modification in neurocognitive functioning through the WAIS-III test.(12 months)
- Change in neurocognitive functioning through the MAC Battery Test.(12 months)
- Change in neurocognitive functioning through the NEUROPSILIN test.(12 months)
- Change in neurocognitive functioning through the evaluation of Comprehension of Written language.(12 months)
- Change in neurocognitive functioning through the evaluation of the Visuospatial Working Memory.(12 months)
- Change in neurocognitive functioning through the Go-no-Go Subtest.(12 months)
- Change in neurocognitive functioning through the Words Span in Sentences Subtest.(12 months)
- Change in neurocognitive functioning through the Psychological Attention Battery.(12 months)
- Change in neurocognitive functioning through the Five Digit Test.(12 months)