NCT03946787

EMDR in Adolescents With Bipolar Disorder and History of Trauma

EMDR Therapy in Relapse Prevention in Mood Episodes in Adolescents With Bipolar Disorder and History of Trauma: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
OTHER	Eye Movement Desensitization and Reprocessing (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.
OTHER	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.

Timeline

• Start date: 2019-02-05
• Primary completion: 2019-08-01
• Completion: 2020-01-01
• First posted: 2019-05-13
• Last updated: 2019-05-13

Locations

1 site across 1 country: Brazil