Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults

University of Bucharest

Status: Completed

Conditions: Hashimoto

Treatments: Drug: Treatment as Usual; Other: Placebo; Behavioral: Eye Movement Desensitization and Reprocessing

Study type: Interventional

Funder types: Other

Identifiers

NCT04472988

39/27.02.2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 3 patient groups, including a placebo group

Eye Movement Desensitization and Reprocessing

Experimental group

Description:

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.

Treatment:

Behavioral: Eye Movement Desensitization and Reprocessing

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Treatment as Usual

Active Comparator group

Description:

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

Treatment:

Drug: Treatment as Usual