Identity Oriented Psychotrauma Therapy on Hashimoto in Adults

Autoimmune Thyroiditis Clinical Trial

Official title:

The Influence of Identity Oriented Psychotrauma Therapy on Hashimoto Disease Activity: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600349
• Other study ID #: 39b/27.02.2019
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: University of Bucharest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Thyroiditis
• Hashimoto Disease
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Behavioral:
• Identity Oriented Psychotrauma Therapy
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.

Drug:
• Treatment as Usual
The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)

Locations

Country	Name	City	State
Romania	University of Bucharest	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
University of Bucharest

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-thyroid peroxidase levels (anti-TPO)	Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up	baseline to 8 months
Primary	Thyroglobulin levels (TgAb)	Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up	baseline to 8 months
Secondary	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%).	baseline to 8 months
Secondary	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).	baseline to 8 months
Secondary	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").	baseline to 8 months
Secondary	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.	baseline to 8 months
Secondary	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.	baseline to 8 months