Identity Oriented Psychotrauma Therapy on Hashimoto in Adults

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

Sponsors

Lead Sponsor: University of Bucharest

Source University of Bucharest
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.

Overall Status Completed
Start Date 2020-02-01
Completion Date 2021-03-01
Primary Completion Date 2020-12-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Anti-thyroid peroxidase levels (anti-TPO) baseline to 8 months
Thyroglobulin levels (TgAb) baseline to 8 months
Secondary Outcome
Measure Time Frame
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
Enrollment 70
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Identity Oriented Psychotrauma Therapy

Description: 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.

Arm Group Label: Identity Oriented Psychotrauma Therapy (IOPT)

Other Name: Intention Method

Intervention Type: Drug

Intervention Name: Treatment as Usual

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

Arm Group Label: Treatment as Usual

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Location
Facility: University of Bucharest
Location Countries

Romania

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Bucharest

Investigator Full Name: Maria Magdalena Macarenco

Investigator Title: BA

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Identity Oriented Psychotrauma Therapy (IOPT)

Type: Experimental

Description: 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.

Label: Treatment as Usual

Type: Active Comparator

Description: 35 participants will be randomized to this group. They will continue only the medical treatment for Hashimoto their doctor prescribed to them.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking Description: 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.

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