An interventional study of Identity Oriented Psychotrauma Therapy and Treatment as Usual in Autoimmune Thyroiditis, sponsored by University of Bucharest. Completed at 1 site in Romania. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-04-23.
Sponsored by University of Bucharest · Not applicable, Interventional, and Supportive care
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.
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.
53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 31 interventional studies indexed under Hashimoto Disease.
Browse Hashimoto Disease studies →University of Bucharest is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
Compared within Hashimoto Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroiditis, Autoimmune. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Identity Oriented Psychotrauma Therapy
35 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 method will be presented to the group at the beginning of the first group session. Then every person from the experimental group will set an Intention connected to the emotional or physical difficulties they experience in their lives. Then the person will choose for every word in their Intention, a representative from the support group who will resonate with that word. The focus of every Intention should be the current illness and the traumatic or stressful events which happened before the disease onset.
Also known as: Intention Method
The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)
Anti-thyroid peroxidase levels (anti-TPO)
Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up
Time frame: baseline to 8 months
Thyroglobulin levels (TgAb)
Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up
Time frame: baseline to 8 months
Dissociative Experiences Scale
Perceptions about the levels of dissociation will be measured at baseline, post-treatment and follow-up. The instrument is a self-assessment questionnaire used to screen for dissociative symptoms. It consists of 28 items that assess the frequency and severity of a wide range of dissociative experiences using an eleven-point visual analog scale (0%-100%).
Time frame: baseline to 8 months
Toronto Alexithymia Scale
Perceptions about alexithymia will be measured at baseline, post-treatment and follow-up.Toronto Alexithymia Scale is a 20 item self-report instrument, with each item rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
Time frame: baseline to 8 months
State-Trait Anger Expression Inventory
Perceptions about anger expression in adults with Hashimoto will be measured at baseline, post-treatment and followup. The inventory assesses a various area of anger and the traits of experiencing anger. Participants are asked to respond to 44 items using a 4-point scale ("Not at all" to "Almost always").
Time frame: baseline to 8 months
The Depression Anxiety Stress Scales
Perceptions about depression, anxiety and stress levels will be measured at baseline, post-treatment and follow-up.The instrument is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three scales contains seven items, ranging from 0 to 21 points, with high scores meaning a worse outcome.
Time frame: baseline to 8 months
The World Health Organization Quality of Life
Perceptions about the quality of life will be measured at baseline, post-treatment and follow-up.The instrument is a 26-item self-report tapping into the following broad domains: physical health, psychological health, social relationships, and environment. There are two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score.
Time frame: baseline to 8 months
Ran from Feb 2020 to primary completion in Dec 2020, 10 months.
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University of Bucharest