EMDR in Adolescents With Bipolar Disorder and History of Trauma

NCT03946787 | Unknown

• 1 other identifier: 2018-0345
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  12 months

Secondary Outcomes (35)

• Change in biological markers measured by morning salivary cortisol 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 C-reactive protein 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 Brain Derived Neurotrophic Factor levels in 6 months.

  6 months

Study Arms (2)

EMDR Therapy + TAU

ACTIVE COMPARATOR

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

TAU (Treatment as Usual)

PLACEBO COMPARATOR

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

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) Therapy OTHER

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

EMDR Therapy + TAU

Treatment as Usual OTHER

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

EMDR Therapy + TAU; TAU (Treatment as Usual)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• substance abuse / dependence within 3 months prior to participation;
• neurological disease or history of brain trauma;
• autism;
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Centro de Pesquisas Clínicas do Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ives C Passos, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ives C Passos, PhD

CONTACT

+555133598845; ivescp1@gmail.com

Tatiana L Peruzzolo

CONTACT

+555133598000; tatiperuzzolo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Group A: Treatment as Usual (TAU); 2. Group B: TAU plus Eye Movement Desensitization and Reprocessing (EMDR) Therapy

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 13, 2019
• Study Start: February 5, 2019
• Primary Completion: August 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 13, 2019

Record last verified: 2019-04

Locations

BR (1)