Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults

Hashimoto Clinical Trial

Official title:

The Effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472988
• Other study ID #: 39/27.02.2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 23, 2021

Study information

• Verified date: April 2021
• Source: University of Bucharest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 23, 2021
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hashimoto
• Hashimoto Disease
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Behavioral:
• Eye Movement Desensitization and Reprocessing
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.

Other:
• Placebo
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.

Drug:
• Treatment as Usual
The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)

Locations

Country	Name	City	State
Romania	University of Bucharest	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
University of Bucharest

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Difficulties in Emotion Regulation Scale	Perceptions of the emotion regulation will be measured at baseline, post-treatment and follow-up, after EMDR treatment. The instrument is designed to assess clinically relevant difficulties in emotion regulation.	Baseline to 6 months
Other	The Outcome Rating Scale and Session Rating scale	This scales are very brief and feasible measures for tracking client well-being and the quality of the therapeutic alliance. The Outcome Rating Scale will be completed by the participant at the beginning of each of the 12 sessions. The Session Rating Scale will be completed by the participant at the end of each of the 12 sessions.	Baseline to 6 months
Other	Intent-to-Attend Scale	The scale is a single-item measure. Participants rate their intention on a nine-point Likert scale, at the end of each session.	Baseline to 6 months
Primary	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
Primary	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	State-Trait Anger Expression Inventory	Perceptions about anger expression in adults with Hashimoto will be measured at baseline, post-treatment and follow-up, after EMDR treatment. The inventory assesses a various area of anger and the traits of experiencing anger. Participants are asked to respond to 44 items using a 4-point scale ("Not at all" to "Almost always").	Baseline to 6 months
Secondary	Toronto Alexithymia Scale	Perceptions about alexithymia will be measured at baseline, post-treatment and follow-up, after EMDR treatment. Toronto Alexithymia Scale is a 20 item self-report instrument, with each item rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).	Baseline to 6 months
Secondary	Dissociative Experiences Scale	Perceptions about the levels of dissociation will be measured at baseline, post-treatment and follow-up, after EMDR treatment. The instrument is a self-assessment questionnaire used to screen for dissociative symptoms. It consists of 28 items that assess the frequency and severity of a wide range of dissociative experiences using an eleven-point visual analog scale (0%-100%).	Baseline to 6 months
Secondary	The Depression Anxiety Stress Scales	Perceptions about depression, anxiety and stress levels will be measured at baseline, post-treatment and follow-up, after EMDR treatment. The instrument is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three scales contains seven items.	Baseline to 6 months
Secondary	The World Health Organization Quality of Life	Perceptions about the quality of life will be measured at baseline, post-treatment and follow-up, after EMDR treatment. The instrument is a 26-item self-report tapping into the following broad domains: physical health, psychological health, social relationships, and environment.	Baseline to 6 months