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Completed

NCT Number: NCT04600349

Identity Oriented Psychotrauma Therapy on Hashimoto in Adults

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.

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Key information

Conditions

Autoimmune Thyroiditis Autoimmune Diseases Endocrine System Diseases Hashimoto Disease Immune System Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bucharest

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Intention Method

Treatment as Usual

Drug

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

Primary outcomes

  1. Anti-thyroid peroxidase levels (anti-TPO)

    Time frame: baseline to 8 months

    Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up

  2. Thyroglobulin levels (TgAb)

    Time frame: baseline to 8 months

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

Secondary outcomes

  1. Dissociative Experiences Scale

    Time frame: baseline to 8 months

    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%).

  2. Toronto Alexithymia Scale

    Time frame: baseline to 8 months

    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).

  3. State-Trait Anger Expression Inventory

    Time frame: baseline to 8 months

    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").

  4. The Depression Anxiety Stress Scales

    Time frame: baseline to 8 months

    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.

  5. The World Health Organization Quality of Life

    Time frame: baseline to 8 months

    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.

Sponsors and collaborators

Lead sponsor

University of Bucharest

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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