HashimotoNCT04472988
Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults
A study testing Eye Movement Desensitization and Reprocessing and Treatment as Usual in people with Hashimoto, run by University of Bucharest at 1 site in Romania.
Trial summary
The purpose of this study is to evaluate whether Eye Movement Desensitization and Reprocessing (EMDR) is effective in decreasing the level of autoantibodies of patients with autoimmune thyroiditis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hashimoto
- What is being tested?
- Eye Movement Desensitization and Reprocessing and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2020to 23 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-55 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 Effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults: a Randomized Controlled Trial
The purpose of this study is to evaluate whether Eye Movement Desensitization and Reprocessing (EMDR) is effective in decreasing the level of autoantibodies of patients with autoimmune thyroiditis. The investigators hypothesize that processing traumatic memories from events that happened before the illness onset will have a positive impact first on the psyche (a) by decreasing the level of dissociation, alexithymia, anger, and (b) by increasing the quality of life and emotional regulation, than those in the control group. Secondly, it will have an 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.
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 three arms: one experimental and two control groups. The experimental group receives EMDR, one control group receive placebo and the other is a waiting list. 90 out-patients with Hashimoto disease will be randomly assigned to the three 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 EMDR group undergoes a 90 minutes session of EMDR each week for twelve weeks.The sessions will be conducted by clinicians or psychotherapists specialized in EMDR. The placebo group will receive a similar amount of time of placebo intervention. If therapy is efficient on the autoimmune disorder, participants in the control groups will be reallocated to EMDR after the experimental treatment will come to an end.
- Conditions
- Hashimoto
- Being tested
- Eye Movement Desensitization and Reprocessing, Placebo, Treatment as Usual
- Keywords
- Hashimoto, Autoimmune thyroiditis, Eye Movement Desensitization adn Reprocessing, Trauma
- Medical subject headings
- Hashimoto Disease, Thyroiditis, Autoimmune, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and ReprocessingBehavioural
The first session will be assigned to the assessment and the exploration of the personal history and for presenting the method to the client. Then, each case will be conceptualized according to the Model of Two Method Approach and the protocol for the treatment will be used. The procedure will be organized around targeting the most ten disturbing memories which happened before the illness debut, including stressful or traumatic memories from childhood. The rationale behind this approach is that adverse events leave traces in the neural network of an individual in such a way that these cause a variety of emotional or cognitive symptoms. If we consider the illness as being also a "symptom" of a traumatic past, then we expect that by accessing the dysfunctionally stored memory and stimulating the innate processing system, the symptoms of the illness diminish.
PlaceboOther
The participants randomised in this group will receive a protocol focused only on present and future (present symptoms, daily problems, future projects). The psychologist will lead the discussion anywhere except for the past.
The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing | Experimental | 30 participants will be randomly allocated to the EMDR group. They will receive a 90 minutes session of EMDR each week for twelve weeks. The sessions will be conducted by clinicians or psychotherapists specialized in EMDR, and the participants will be randomly allocated to them.
EMDR is a structured, goal-oriented, short-term intervention organized around traumatic or stressful memories. This method was discovered in 1981 by F. Shapiro and represented an evidence-based treatment, one of the two first-line trauma treatment recommended for use with adults (NICE, 2005; World Health Organization, 2013). EMDR proved effective by hundreds of researches and has also been shown to be useful in alleviating physical symptoms such as pain or increased autonomic activity. But to our knowledge, research on EMDR efficacy in the treatment of autoimmune thyroiditis has not been previously reported. Receives: Behavioral: Eye Movement Desensitization and Reprocessing |
| Placebo | Placebo comparator | 30 participants will be randomized to the placebo group. The placebo goup will receive an intervention that does not include working on past traumatic memories, it will be more focused on present and future. Receives: Other: Placebo |
| Treatment as Usual | Active comparator | 30 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.
Measurement of anti-thyroid peroxidase levels (anti-TPO)
Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR
Measured: baseline to 6 months
Measurement of thyroglobulin levels (TgAb)
Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR
Measured: baseline to 6 months
Secondary outcomes (5)
State-Trait Anger Expression Inventory
Perceptions about anger expression in adults with Hashimoto will be measured at baseline, post-treatment and follow-up, after EMDR treatment. 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 6 months
Toronto Alexithymia Scale
Perceptions about alexithymia will be measured at baseline, post-treatment and follow-up, after EMDR treatment. 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 6 months
Dissociative Experiences Scale
Perceptions about the levels of dissociation will be measured at baseline, post-treatment and follow-up, after EMDR treatment. 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 6 months
The Depression Anxiety Stress Scales
Perceptions about depression, anxiety and stress levels will be measured at baseline, post-treatment and follow-up, after EMDR treatment. 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.
Measured: Baseline to 6 months
The World Health Organization Quality of Life
Perceptions about the quality of life will be measured at baseline, post-treatment and follow-up, after EMDR treatment. The instrument is a 26-item self-report tapping into the following broad domains: physical health, psychological health, social relationships, and environment.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Jan 2020
- Primary completion5 Dec 2020
- Study completion23 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 HashimotoStudies 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
- 91 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
- NCT04472988
- Sponsor's protocol ID
- 39/27.02.2019
- Status last verified
- Apr 2021
- First submitted
- 7 Jul 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, Caciuloiu L. Psychological and immunological benefits of eye movement desensitization and reprocessing in hashimoto thyroiditis: Preliminary findings from a randomized controlled trial. Psychoneuroendocrinology. 2026 Feb;184:107695. doi: 10.1016/j.psyneuen.2025.107695. Epub 2025 Nov 14.
PubMed 41265021
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 Effects of Eye Movement Desensitization and Reprocessing on Autoimmune Thyroiditis in Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04472988
- Acronym / sponsor ID
- 39/27.02.2019
- Conditions
- Hashimoto
- Keywords
- Hashimoto, Autoimmune thyroiditis, Eye Movement Desensitization adn Reprocessing, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of BucharestUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 16 Jul 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 Eye Movement Desensitization and Reprocessing (EMDR) is effective in decreasing the level of autoantibodies of patients with autoimmune thyroiditis. The investigators hypothesize that processing traumatic memories from events that happened before the illness onset will have a positive impact first on the psyche (a) by decreasing the level of dissociation, alexithymia, anger, and (b) by increasing the quality of life and emotional regulation, than those in the control group. Secondly, it will have an 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.
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 three arms: one experimental and two control groups. The experimental group receives EMDR, one control group receive placebo and the other is a waiting list. 90 out-patients with Hashimoto disease will be randomly assigned to the three 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 EMDR group undergoes a 90 minutes session of EMDR each week for twelve weeks.The sessions will be conducted by clinicians or psychotherapists specialized in EMDR. The placebo group will receive a similar amount of time of placebo intervention. If therapy is efficient on the autoimmune disorder, participants in the control groups will be reallocated to EMDR 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing30 participants will be randomly allocated to the EMDR group. They will receive a 90 minutes session of EMDR each week for twelve weeks. The sessions will be conducted by clinicians or psychotherapists specialized in EMDR, and the participants will be randomly allocated to them. EMDR is a structured, goal-oriented, short-term intervention organized around traumatic or stressful memories. This method was discovered in 1981 by F. Shapiro and represented an evidence-based treatment, one of the two first-line trauma treatment recommended for use with adults (NICE, 2005; World Health Organization, 2013). EMDR proved effective by hundreds of researches and has also been shown to be useful in alleviating physical symptoms such as pain or increased autonomic activity. But to our knowledge, research on EMDR efficacy in the treatment of autoimmune thyroiditis has not been previously reported. |
| Placebo | Placebo comparator | Other: Placebo30 participants will be randomized to the placebo group. The placebo goup will receive an intervention that does not include working on past traumatic memories, it will be more focused on present and future. |
| Treatment as Usual | Active comparator | Drug: Treatment as Usual30 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 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-55 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 |
|---|---|---|
| Eye Movement Desensitization and ReprocessingThe first session will be assigned to the assessment and the exploration of the personal history and for presenting the method to the client. Then, each case will be conceptualized according to the Model of Two Method Approach and the protocol for the treatment will be used. The procedure will be organized around targeting the most ten disturbing memories which happened before the illness debut, including stressful or traumatic memories from childhood. The rationale behind this approach is that adverse events leave traces in the neural network of an individual in such a way that these cause a variety of emotional or cognitive symptoms. If we consider the illness as being also a "symptom" of a traumatic past, then we expect that by accessing the dysfunctionally stored memory and stimulating the innate processing system, the symptoms of the illness diminish. | Behavioural | Eye Movement Desensitization and Reprocessing |
| PlaceboThe participants randomised in this group will receive a protocol focused only on present and future (present symptoms, daily problems, future projects). The psychologist will lead the discussion anywhere except for the past. | Other | Placebo |
| Treatment as UsualThe participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine) | Drug | Treatment as Usual |
Primary outcome
Measurement of anti-thyroid peroxidase levels (anti-TPO)
Time frame: baseline to 6 months
Measurement of anti-thyroid peroxidase in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR
Measurement of thyroglobulin levels (TgAb)
Time frame: baseline to 6 months
Measurement of thyroglobulin antibodies levels in adults with Hashimoto at baseline, post-treatment and follow-up, after trauma therapy with EMDR
5 secondary outcomes
State-Trait Anger Expression Inventory
Time frame: Baseline to 6 months
Toronto Alexithymia Scale
Time frame: Baseline to 6 months
Dissociative Experiences Scale
Time frame: Baseline to 6 months
The Depression Anxiety Stress Scales
Time frame: Baseline to 6 months
The World Health Organization Quality of Life
Time frame: Baseline to 6 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 41265021Macarenco MM, Opariuc-Dan C, Georgescu T, Caciuloiu L. Psychological and immunological benefits of eye movement desensitization and reprocessing in hashimoto thyroiditis: Preliminary findings from a randomized controlled trial. Psychoneuroendocrinology. 2026 Feb;184:107695. doi: 10.1016/j.psyneuen.2025.107695. Epub 2025 Nov 14.
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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 Eye Movement Desensitization and Reprocessing and Treatment as Usual in people with Hashimoto, 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. Some participants in this study may receive a placebo. 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?
Measurement of anti-thyroid peroxidase levels (anti-TPO) (time frame: baseline to 6 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 NCT04472988, 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.