The Influence of Identity Oriented Psychotrauma Therapy on Hashimoto Disease Activity: 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
- 70
- 试验地点
- 1
- 主要终点
- Anti-thyroid peroxidase levels (anti-TPO)
研究概览
简要总结
The purpose of this study is to evaluate whether Identity Oriented Psychotrauma Therapy (IOPT) is effective in decreasing the level of autoantibodies of patients with Hashimoto thyroiditis. The investigators hypothesize that working Constellations of Intention will have a positive 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. Secondly, it will have an impact on the psyche by decreasing the level of dissociation, alexithymia, anger, and by increasing the quality of life and than those in the control group.
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 two arms: one experimental and one control group. The experimental group receives IOPT and the control group is a waiting list. 70 out-patients with Hashimoto disease will be randomly assigned to the two 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 IOPT group undergoes 10 group modules of IOPT once at two weeks.The sessions will be conducted by clinicians or psychotherapists specialized in IOPT. If therapy is efficient on the autoimmune disorder, participants in the control group will be reallocated to IOPT 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, posttreatment and follow-up.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-60 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
Identity Oriented Psychotrauma Therapy (IOPT)
35 participants will be randomly allocated to the IOPT group. They will attend 10 groups of IOPT every two weeks and they will work 10 Intentions. The groups will be conducted by clinicians or psychotherapists specialized in IOPT. IOPT represents a group treatment developed by Franz Ruppert 20 years ago. It is an effective therapeutic intervention, offering access to less conscious aspects of our psyche, with the help of other persons, named 'representatives.' The method is based on the theory of multigenerational psychotraumatology developed by Ruppert. Although it is very often and widely used all over the world, it has not previously been the subject of randomized controlled trials (RCT), and therefore, its potential efficacy is unknown. In the current study, we want to test this new intervention model on autoimmune thyroiditis.
干预措施: Identity Oriented Psychotrauma Therapy (Behavioral)
Treatment as Usual
35 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
Anti-thyroid peroxidase levels (anti-TPO)
时间窗: baseline to 8 months
Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up
Thyroglobulin levels (TgAb)
时间窗: baseline to 8 months
Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up
次要结局
- State-Trait Anger Expression Inventory(baseline to 8 months)
- The Depression Anxiety Stress Scales(baseline to 8 months)
- The World Health Organization Quality of Life(baseline to 8 months)
- Toronto Alexithymia Scale(baseline to 8 months)
- Dissociative Experiences Scale(baseline to 8 months)
研究者
Maria Magdalena Macarenco
BA
University of Bucharest