Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 06/30/2020 |
| Прво доставено: | 07/06/2020 |
| Поднесено е проценето запишување: | 07/09/2020 |
| Прво објавено: | 07/15/2020 |
| Последното ажурирање е доставено: | 07/09/2020 |
| Последно ажурирање објавено: | 07/15/2020 |
| Крај на датумот на започнување на студијата: | 12/31/2019 |
| Проценет датум на примарно завршување: | 11/30/2020 |
| Проценет датум на завршување на студијата: | 02/28/2021 |
Состојба или болест
Интервенција / третман
Behavioral: Eye Movement Desensitization and Reprocessing
Other: Placebo
Drug: Treatment as Usual
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Experimental: 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. | 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. |
| Placebo Comparator: 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. | 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. |
| Active Comparator: 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. | Drug: Treatment as Usual The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine) |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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 |
Исход
Мерки на примарниот исход
1. Measurement of anti-thyroid peroxidase levels (anti-TPO) [baseline to 6 months]
2. Measurement of thyroglobulin levels (TgAb) [baseline to 6 months]
Секундарни мерки на исходот
1. State-Trait Anger Expression Inventory [Baseline to 6 months]
2. Toronto Alexithymia Scale [Baseline to 6 months]
3. Dissociative Experiences Scale [Baseline to 6 months]
4. The Depression Anxiety Stress Scales [Baseline to 6 months]
5. The World Health Organization Quality of Life [Baseline to 6 months]
Други мерки на исход
1. The Difficulties in Emotion Regulation Scale [Baseline to 6 months]
2. The Outcome Rating Scale and Session Rating scale [Baseline to 6 months]
3. Intent-to-Attend Scale [Baseline to 6 months]
