Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults

NCT04472988 | Completed DMC

• 1 other identifier: 39/27.02.2019
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether Eye Movement Desensitization and Reprocessing (EMDR) is effective in decreasing the level of autoantibodies of patients with autoimmune thyroiditis. The investigators hypothesize that processing traumatic memories from events that happened before the illness onset will have a positive impact first on the psyche (a) by decreasing the level of dissociation, alexithymia, anger, and (b) by increasing the quality of life and emotional regulation, than those in the control group. Secondly, it will have an impact on the biological level, by decreasing the level of autoantibodies, antithyroglobulin antibody (anti-Tg) and anti-thyroid peroxidase antibody (anti-TPO), which are the main antibodies detected in chronic autoimmune thyroiditis.

Conditions

Hashimoto

Keywords

Hashimoto; Autoimmune thyroiditis; Eye Movement Desensitization adn Reprocessing; Trauma

Outcome Measures

Primary Outcomes (2)

• Measurement of anti-thyroid peroxidase levels (anti-TPO)

  Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR

  baseline to 6 months

• Measurement of thyroglobulin levels (TgAb)

  Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR

  baseline to 6 months

Secondary Outcomes (5)

• State-Trait Anger Expression Inventory

  Baseline to 6 months

• Toronto Alexithymia Scale

  Baseline to 6 months

• Dissociative Experiences Scale

  Baseline to 6 months

• The Depression Anxiety Stress Scales

  Baseline to 6 months

• The World Health Organization Quality of Life

  Baseline to 6 months

Other Outcomes (3)

• The Difficulties in Emotion Regulation Scale

  Baseline to 6 months

• The Outcome Rating Scale and Session Rating scale

  Baseline to 6 months

• Intent-to-Attend Scale

  Baseline to 6 months

Study Arms (3)

Eye Movement Desensitization and Reprocessing

EXPERIMENTAL

30 participants will be randomly allocated to the EMDR group. They will receive a 90 minutes session of EMDR each week for twelve weeks. The sessions will be conducted by clinicians or psychotherapists specialized in EMDR, and the participants will be randomly allocated to them. EMDR is a structured, goal-oriented, short-term intervention organized around traumatic or stressful memories. This method was discovered in 1981 by F. Shapiro and represented an evidence-based treatment, one of the two first-line trauma treatment recommended for use with adults (NICE, 2005; World Health Organization, 2013). EMDR proved effective by hundreds of researches and has also been shown to be useful in alleviating physical symptoms such as pain or increased autonomic activity. But to our knowledge, research on EMDR efficacy in the treatment of autoimmune thyroiditis has not been previously reported.

Behavioral: Eye Movement Desensitization and Reprocessing

Placebo

PLACEBO COMPARATOR

30 participants will be randomized to the placebo group. The placebo goup will receive an intervention that does not include working on past traumatic memories, it will be more focused on present and future.

Other: Placebo

Treatment as Usual

ACTIVE COMPARATOR

30 participants will be randomized to this group. They will continue only the medical treatment for Hashimoto their doctor prescribed to them.

Drug: Treatment as Usual

Interventions

Eye Movement Desensitization and Reprocessing BEHAVIORAL

The first session will be assigned to the assessment and the exploration of the personal history and for presenting the method to the client. Then, each case will be conceptualized according to the Model of Two Method Approach and the protocol for the treatment will be used. The procedure will be organized around targeting the most ten disturbing memories which happened before the illness debut, including stressful or traumatic memories from childhood. The rationale behind this approach is that adverse events leave traces in the neural network of an individual in such a way that these cause a variety of emotional or cognitive symptoms. If we consider the illness as being also a "symptom" of a traumatic past, then we expect that by accessing the dysfunctionally stored memory and stimulating the innate processing system, the symptoms of the illness diminish.

Eye Movement Desensitization and Reprocessing

Placebo OTHER

The participants randomised in this group will receive a protocol focused only on present and future (present symptoms, daily problems, future projects). The psychologist will lead the discussion anywhere except for the past.

Placebo

Treatment as Usual DRUG

The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-55 years;
• confirmed autoimmune thyroiditis diagnosis
• at least one biological marker Anti-thyroid peroxidase (anti-TPO) antibodies or thyroglobulin antibodies (TgAb) exceeds the reference range

You may not qualify if:

• the presence of psychotic symptoms
• currently receiving another form of psychological treatment;
• under psychotropic medication;
• neurodevelopmental disorders (intellectual disability, communication disorders, autism spectrum disorders, ADHD);
• neurocognitive disorders;
• substance abuse;
• serious legal or health issues that would prevent from regularly attending
• patients with autoimmune thyroiditis with biological markers within the reference range

Sponsors & Collaborators

• University of Bucharest: lead

Study Sites (1)

University of Bucharest

Bucharest, Romania

Location

MeSH Terms

Conditions

Hashimoto Disease; Thyroiditis, Autoimmune; Wounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the study an endocrinologist who will be blinded to randomization groups will evaluate the biological markers of the participants at baseline, post-treatment and follow-up.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in adults: a randomized controlled trial

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 16, 2020
• Study Start: January 1, 2020
• Primary Completion: December 5, 2020
• Study Completion: March 23, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

RO (1)