NCT04472988

Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of Bucharest · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hashimoto

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-12-05
• Completion: 2021-03-23
• First posted: 2020-07-16
• Last updated: 2021-04-23

Locations

1 site across 1 country: Romania