EMDR in Adolescents With Bipolar Disorder and History of Trauma

NCT ID: NCT03946787

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2020-01-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Eye Movement Desensitization and Reprocessing (EMDR) Therapy

Intervention Type: 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.

Treatment as Usual

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

EMDR Therapy; TAU

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ives C Passos, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

Centro de Pesquisas Clínicas do Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Ives C Passos, PhD

Role: CONTACT

ivescp1@gmail.com

+555133598845

Tatiana L Peruzzolo

Role: CONTACT

tatiperuzzolo@gmail.com

+555133598000

Facility Contacts

Andrea Rambo

Role: primary

l-cpc-recepcao@hcpa.edu.br

+555133598943

Tatiana L Peruzzolo

Role: backup

tperuzzolo_pos@hcpa.edu.br

+555133598943

Other Identifiers

2018-0345

Identifier Type: -

Identifier Source: org_study_id