Clinical trial NCT03946787: EMDR in Adolescents With Bipolar Disorder and History of Trauma
Official title: EMDR Therapy in Relapse Prevention in Mood Episodes in Adolescents With Bipolar Disorder and History of Trauma: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 82
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Group A: Treatment as Usual (TAU);
2. Group B: TAU plus Eye Movement Desensitization and Reprocessing (EMDR) Therapy
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. age between 12 and 17 years and 11 months;
2. 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;
3. Presence of one or more distressing traumatic events, assessed by:

   1. 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;
   2. Holmes Rahes Stress Inventory for non-adults (H-RLSI) with frequency\> 1;
   3. Children Revised Impact of Event Scale (CRIES)\> 0;
   4. Childhood Trauma Questionnaire (CTQ)\> 0; and
   5. at least 5 points in the disturbance assessment by the Subjective Units of Disturbance (SUDS) scale.

Exclusion Criteria:

1. substance abuse / dependence within 3 months prior to participation;
2. neurological disease or history of brain trauma;
3. autism;
4. Intelligence Quotient \<70;
5. suicidal or homicidal ideation;
6. prior involvement in trauma-focused therapy;
7. psychotherapy during the study and months of follow-up, and;
8. a score greater than 25 on the Adolescent Dissociative Experience Scale, since the presence of massive dissociation requires different and more extensive treatment protocols.

Primary outcomes:
measure: Reduction in the number of manic switches.
timeFrame: 12 months
measure: Reduction in the number of depressive episodes
timeFrame: 12 months
Secondary outcomes:
measure: Change in biological markers measured by morning salivary cortisol levels in 6 months
timeFrame: 6 months
measure: Change in biological markers measured by morning salivary cortisol levels in 12 months
timeFrame: 12 months
measure: Change in biological markers measured by C-reactive protein levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by C-reactive protein levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Brain Derived Neurotrophic Factor levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Interleukin-1 Beta levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Interleukin-1 Beta levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Interleukin-2 levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Interleukin-2 levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Interleukin-4 levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Interleukin-4 levels in 12 months.
timeFrame: 12 months
measure: Improvement in biological markers measured by Interleukin-6 levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Interleukin-6 levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Interleukin-10 levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Interleukin-10 levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Interferon-gamma levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Interferon-gamma levels in 12 months.
timeFrame: 12 months
measure: Change in biological markers measured by Tumor Necrosis Factor alpha levels in 6 months.
timeFrame: 6 months
measure: Change in biological markers measured by Tumor Necrosis Factor alpha levels in 12 months.
timeFrame: 12 months
measure: Modification in neurocognitive functioning through the WASI test.
timeFrame: 12 months
measure: Modification in neurocognitive functioning through the WISC-III test.
timeFrame: 12 months
measure: Modification in neurocognitive functioning through the WAIS-III test.
timeFrame: 12 months
measure: Modification in neurocognitive functioning through the MAC Battery.
timeFrame: 12 months
measure: Modification in neurocognitive functioning through the Hayling Test.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the MAC Battery Test.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the DNE test.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the NEUROPSILIN test.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the evaluation of Comprehension of Written language.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the evaluation of the Visuospatial Working Memory.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the Go-no-Go Subtest.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the Words Span in Sentences Subtest.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the Five Digit Test.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the Psychological Attention Battery.
timeFrame: 12 months
measure: Change in neurocognitive functioning through the Test of School Performance.
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisas Clínicas do Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Ives C Passos, PhD
role: PRINCIPAL_INVESTIGATOR
References: