EMDR in Adolescents With Bipolar Disorder and History of Trauma

Last updated: May 10, 2019
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bipolar Disorder

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT03946787
2018-0345
  • Ages 12-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age between 12 and 17 years and 11 months;

  2. current clinical state of euthymia (patient stable or euthymic) after clinicalevaluation, defined as the presence of clinical remission (CDRS ≤ 40, YMRS ≤ 12.5 andCGAS (Children's Global Assessment Scale) ≥ 51), being the presence of subsyndromicsymptoms (YMRS> 8 and <14) admissible;

  3. Presence of one or more distressing traumatic events, assessed by:

  4. Trauma subscale of the Post Traumatic Stress Disorder Questionnaire from theSchedule for Affective Disorders and Schizophrenia for School Aged ChildrenPresent and Lifetime Version (K-SADS-PL) , with frequency> 1;

  5. Holmes Rahes Stress Inventory for non-adults (H-RLSI) with frequency> 1;

  6. Children Revised Impact of Event Scale (CRIES)> 0;

  7. Childhood Trauma Questionnaire (CTQ)> 0; and

  8. at least 5 points in the disturbance assessment by the Subjective Units ofDisturbance (SUDS) scale.

Exclusion

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 thepresence of massive dissociation requires different and more extensive treatmentprotocols.

Study Design

Total Participants: 82
Study Start date:
February 05, 2019
Estimated Completion Date:
January 31, 2020

Study 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.

Connect with a study center

  • Centro de Pesquisas Clínicas do Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-007
    Brazil

    Active - Recruiting

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