Autoimmune ThyroiditisNCT04600349
Identity Oriented Psychotrauma Therapy on Hashimoto in Adults
A study testing Identity Oriented Psychotrauma Therapy and Treatment as Usual in people with Autoimmune Thyroiditis, run by University of Bucharest at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autoimmune Thyroiditis
- What is being tested?
- Identity Oriented Psychotrauma Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRomania
- Study dates
- 1 Feb 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Identity Oriented Psychotrauma Therapy on Hashimoto Disease Activity: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Autoimmune Thyroiditis
- Being tested
- Identity Oriented Psychotrauma Therapy, Treatment as Usual
- Keywords
- Hashimoto, Autoimmune thyroiditis, Identity Oriented Psychotrauma Therapy, Intention Method
- Medical subject headings
- Thyroiditis, Autoimmune, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identity Oriented Psychotrauma TherapyBehavioural
Also called Intention Method
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.
The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-thyroid peroxidase levels (anti-TPO)
Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up
Measured: baseline to 8 months
Thyroglobulin levels (TgAb)
Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up
Measured: baseline to 8 months
Secondary outcomes (5)
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%).
Measured: baseline to 8 months
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).
Measured: baseline to 8 months
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").
Measured: baseline to 8 months
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.
Measured: baseline to 8 months
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.
Measured: baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Feb 2020
- Primary completion30 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bucharest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Magdalena Macarenco, University of Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600349
- Sponsor's protocol ID
- 39b/27.02.2019
- Status last verified
- Apr 2021
- First submitted
- 19 Oct 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40568843
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Identity Oriented Psychotrauma Therapy on Hashimoto Disease Activity: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04600349
- Acronym / sponsor ID
- 39b/27.02.2019
- Conditions
- Autoimmune Thyroiditis
- Keywords
- Hashimoto, Autoimmune thyroiditis, Identity Oriented Psychotrauma Therapy, Intention Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BucharestUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Identity Oriented Psychotrauma Therapy (IOPT) | Experimental | Behavioral: Identity Oriented Psychotrauma Therapy35 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. |
| Treatment as Usual | Active comparator | Drug: Treatment as Usual35 participants will be randomized to this group. They will continue only the medical treatment for Hashimoto their doctor prescribed to them. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identity Oriented Psychotrauma TherapyAlso: Intention MethodThe 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. | Behavioural | Identity Oriented Psychotrauma Therapy (IOPT) |
| Treatment as UsualThe participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine) | Drug | Treatment as Usual |
Primary outcome
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
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
5 secondary outcomes
Dissociative Experiences Scale
Time frame: baseline to 8 months
Toronto Alexithymia Scale
Time frame: baseline to 8 months
State-Trait Anger Expression Inventory
Time frame: baseline to 8 months
The Depression Anxiety Stress Scales
Time frame: baseline to 8 months
The World Health Organization Quality of Life
Time frame: baseline to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Derived from this study: PubMed 40568843Macarenco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identity Oriented Psychotrauma Therapy and Treatment as Usual in people with Autoimmune Thyroiditis, run by University of Bucharest at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-thyroid peroxidase levels (anti-TPO) (time frame: baseline to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.