Identity Oriented Psychotrauma Therapy on Hashimoto in Adults

NCT04600349 | Completed DMC

• 1 other identifier: 39b/27.02.2019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Thyroiditis

Keywords

Hashimoto; Autoimmune thyroiditis; Identity Oriented Psychotrauma Therapy; Intention Method

Outcome Measures

Primary Outcomes (2)

• 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

• Thyroglobulin levels (TgAb)

  Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up

  baseline to 8 months

Secondary Outcomes (5)

• Dissociative Experiences Scale

  baseline to 8 months

• Toronto Alexithymia Scale

  baseline to 8 months

• State-Trait Anger Expression Inventory

  baseline to 8 months

• The Depression Anxiety Stress Scales

  baseline to 8 months

• The World Health Organization Quality of Life

  baseline to 8 months

Study Arms (2)

Identity Oriented Psychotrauma Therapy (IOPT)

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Identity Oriented Psychotrauma Therapy BEHAVIORAL

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

Identity Oriented Psychotrauma Therapy (IOPT)

Treatment as Usual DRUG

The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bucharest: lead

Study Sites (1)

University of Bucharest

Bucharest, Romania

Location

Related Publications (1)

• Macarenco MM, Opariuc-Dan C, Georgescu T. The influence of identity-oriented psychotrauma therapy on Hashimoto disease activity: a randomised controlled trial. Eur J Psychotraumatol. 2025 Dec;16(1):2520636. doi: 10.1080/20008066.2025.2520636. Epub 2025 Jun 26.

  PMID: 40568843 DERIVED

MeSH Terms

Conditions

Thyroiditis, Autoimmune; Hashimoto Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the study an endocrinologist who will be blinded to randomization groups will evaluate the biological markers of the participants at baseline, posttreatment and follow-up.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BA

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: February 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: March 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

RO (1)