The Effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Measurement of thyroglobulin levels (TgAb)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Eye Movement Desensitization and Reprocessing
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.
干预措施: Eye Movement Desensitization and Reprocessing (Behavioral)
Placebo
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.
干预措施: Placebo (Other)
Treatment as Usual
30 participants will be randomized to this group. They will continue only the medical treatment for Hashimoto their doctor prescribed to them.
干预措施: Treatment as Usual (Drug)
结局指标
主要结局
Measurement of thyroglobulin levels (TgAb)
时间窗: baseline to 6 months
Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR
Measurement of anti-thyroid peroxidase levels (anti-TPO)
时间窗: baseline to 6 months
Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR
次要结局
- State-Trait Anger Expression Inventory(Baseline to 6 months)
- Dissociative Experiences Scale(Baseline to 6 months)
- Toronto Alexithymia 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)
研究者
Maria Magdalena Macarenco
The effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in adults: a randomized controlled trial
University of Bucharest