Clinical trial NCT04472988: Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults
Official title: The Effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hashimoto
Keywords: Hashimoto
Autoimmune thyroiditis
Eye Movement Desensitization adn Reprocessing
Trauma
Lead sponsor: University of Bucharest
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Hashimoto thyroiditis is an autoimmune disease that leads to chronic inflammation of the thyroid gland. This is considered the most common autoimmune disorder, and the most common endocrine disorder. Psychological trauma has been suggested as a possible factor in the pathogenesis and development of autoimmune diseases. Although a diversity of psychotherapeutic interventions have been studied in adults with autoimmune diseases, there is a lack of psychological research and randomized controlled trials in the field of the Hashimoto disease.

This study is designed to be a clinical trial with three arms: one experimental and two control groups. The experimental group receives EMDR, one control group receive placebo and the other is a waiting list. 90 out-patients with Hashimoto disease will be randomly assigned to the three groups. The investigators hypothesize that the therapeutic gains will be more significant in the experimental condition than in the control groups at the completion of the therapy and that this will be maintained at the 3-month follow-up.The EMDR group undergoes a 90 minutes session of EMDR each week for twelve weeks.The sessions will be conducted by clinicians or psychotherapists specialized in EMDR. The placebo group will receive a similar amount of time of placebo intervention. If therapy is efficient on the autoimmune disorder, participants in the control groups will be reallocated to EMDR after the experimental treatment will come to an end.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measurement of anti-thyroid peroxidase levels (anti-TPO)
timeFrame: baseline to 6 months
measure: Measurement of thyroglobulin levels (TgAb)
timeFrame: baseline to 6 months
Secondary outcomes:
measure: State-Trait Anger Expression Inventory
timeFrame: Baseline to 6 months
measure: Toronto Alexithymia Scale
timeFrame: Baseline to 6 months
measure: Dissociative Experiences Scale
timeFrame: Baseline to 6 months
measure: The Depression Anxiety Stress Scales
timeFrame: Baseline to 6 months
measure: The World Health Organization Quality of Life
timeFrame: Baseline to 6 months
Other outcomes:
measure: The Difficulties in Emotion Regulation Scale
timeFrame: Baseline to 6 months
measure: The Outcome Rating Scale and Session Rating scale
timeFrame: Baseline to 6 months
measure: Intent-to-Attend Scale
timeFrame: Baseline to 6 months
Locations:
city: Bucharest
country: Romania
facility: University of Bucharest
Study officials:
References: