Clinical trial NCT04600349: Identity Oriented Psychotrauma Therapy on Hashimoto in Adults
Official title: The Influence of Identity Oriented Psychotrauma Therapy on Hashimoto Disease Activity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Thyroiditis
Keywords: Hashimoto
Autoimmune thyroiditis
Identity Oriented Psychotrauma Therapy
Intention Method
Lead sponsor: University of Bucharest
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Anti-thyroid peroxidase levels (anti-TPO)
timeFrame: baseline to 8 months
measure: Thyroglobulin levels (TgAb)
timeFrame: baseline to 8 months
Secondary outcomes:
measure: Dissociative Experiences Scale
timeFrame: baseline to 8 months
measure: Toronto Alexithymia Scale
timeFrame: baseline to 8 months
measure: State-Trait Anger Expression Inventory
timeFrame: baseline to 8 months
measure: The Depression Anxiety Stress Scales
timeFrame: baseline to 8 months
measure: The World Health Organization Quality of Life
timeFrame: baseline to 8 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: University of Bucharest
Study officials:
References: