Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600349
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2020-10-19
Brief Title:
Identity Oriented Psychotrauma Therapy on Hashimoto in Adults
Sponsor:
University of Bucharest
Organization:
University of Bucharest
Study Overview
Official Title:
The Influence of Identity Oriented Psychotrauma Therapy on Hashimoto Disease Activity a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-upThe IOPT group undergoes 10 group modules of IOPT once at two weeksThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None