Depressive and Anxiety DisordersTETNCT06950970
Evaluating the Effectiveness of Tion-Emo Therapy and Technique (TET)
A study testing Tion-Emo therapy and technique for depression and anxiety Improvement in people with Depressive and Anxiety Disorders, run by Rafael Navia at 1 site in Ecuador.
Trial summary
The goal of this clinical trial is to explore the new therapy Cion-Emo therapy (TET) and to see if this technique is effective for treating depression and anxiety. Does TET lower anxiety and depression as participants learn and use this therapy? Researchers will compare TET with a control group to see if TET works in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive and Anxiety Disorders
- What is being tested?
- Tion-Emo therapy and technique for depression and anxiety Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteEcuador
- Study dates
- 14 Sep 2023to 8 Feb 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion: Confirmed diagnosis of depressive disorder or anxiety disorder: Based on clinical interview according to DSM criteria
- Age between 18 and 75 years
- Baseline symptom severity
- BAI score ≥ 22 (indicating at least moderate anxiety)
- Ability to attend intervention sessions for 12 weeks as part of the study protocol
- Informed consent signed before enrollment
- Exclusion Criteria: Diagnosis of bipolar disorder, schizophrenia, or psychotic disorders, as these conditions may require different treatment approaches and could confound results.
- Substance abuse or dependency, evaluated in the screaning interview.
- Severe neurological impairment or cognitive disorder, that may limit participation and affect the study outcomes.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
TET institute for development of psychotherapy and artificial emotion
Portoviejo, Manabí, 130102
About this study
Official title: Assessing the Effectiveness of Tion-Emo Therapy and Technique as a New Treatment Option for Depression and Anxiety
The goal of this clinical trial is to explore the new therapy Cion-Emo therapy (TET) and to see if this technique is effective for treating depression and anxiety. Does TET lower anxiety and depression as participants learn and use this therapy? Researchers will compare TET with a control group to see if TET works in treating depression and anxiety. There was a pre-test and a post-test for both groups, experimental and control, and questionnaires to evaluate the effectiveness of TET. There was also a question to evaluate the hypothesis of the existence of nucleon emotion. The experimental group received TET therapy and techniques on an average of 10 to 12 one-hour sessions per week. The control group visited the clinic three times: in the first week all participants were evaluated to ascertain whether they were suffering from anxiety and depression; the second time was for the pre-test; and the third time was for the post-test.
Read the detailed description
The TION-EMO theory (TET) was developed in Finland approximately four decades ago with positive results in the public and private sectors. Positive results were also seen in Ecuador. The psychological system is divided into three regions: the first is a self-survival region to regulate all emotions connected with survival. For example, when a person wants to avoid getting contaminated with COVID-19, the survival region is activated in to avoid contracting the disease. Another clear example occurs when people see a tiger- the first thing they want to do is escape. This example of survival mechanism is good; however, the bad effect is that in many cases the self-survival emotions remain long after the incident has occurred, causing a negative effect on health. Depression and anxiety are mostly affected by the social region- the area connected with humans' relations with the people they meet. Finally, people have the intellectual region. The author discovered that when people imagine themselves feeling their own body, they automatically make direct contact with the self-survival region. In the case of self-survival anxiety, people can imagine the object which is causing anxiety. Lately, investigators have noticed that people do not need this self-survival object because it does not have any responsibility. TET therapy addresses this self-survival object through supervised guidance by trained therapists. All this guidance has a very special effect on people's moods. In the case of anxieties and depressions caused by the social region, people imagine the self-object, that is, the individual plus the social object that is causing the anxiety or depression plus the supporting words, which can only be understandable phrases agreed upon by the patient and taught by the therapist. This process takes three to four sessions to understand the logic of the therapy. Several authors consider human objects to be important in the development of emotions, as well as their cognitive components in the comparison of the two. The research will focus on demonstrating that people who use the CION-EMO technique can regulate the symptoms of anxiety and depression caused by conflict and stress. This research is highly desirable.
- Conditions
- Depressive and Anxiety Disorders
- Being tested
- Tion-Emo therapy and technique for depression and anxiety Improvement
- Keywords
- Objects, Therapy, comparison, Depression, Anxiety
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tion-Emo therapy and technique for depression and anxiety ImprovementBehavioural
From 10 a 12 sessions once a week and one hour each session , for a positive result and development it is necessary to practice the technique
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm: "Patients receiving the investigational TET therapy and technique ." | Experimental | The experimental group received the TET therapy and technique based on its theoretical framework between 10 and 12 sessions for one hour each. Receives: Behavioral: Tion-Emo therapy and technique for depression and anxiety Improvement |
| Treatment Arm: "Patients not receiving the investigational TET therapy." | No intervention | The patients did not receive any treatment, only pre-test and post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of depressive symptoms
Assessment of the severity of depressive symptoms using the Beck Depression Inventory II (BDI-II), a self-report questionnaire with 21 items, each scored from 0 to 3. The total score ranges from 0 to 63, with interpretive ranges defined as:
0-13: Minimal depression 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression Unit of Measure: Total score on the BDI-II.
All statistical analyses were performed in R (v4.3) using:
- ordinal: for modeling with a mixed ordinal regression approach
- emmeans: for post hoc comparisons
- MuMIn: for model fit metrics
- ggplot2: for graphical display of results
Measured: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
Improvement in anxiety symptoms
Measured using the Beck Anxiety Inventory (BAI), a self-report questionnaire consisting of 21 questions. Each item is scored from 0 to 3, yielding a total score range of 0 to 63. The suggested cut-off points for anxiety levels are:
0-21: Very low anxiety 22-35: Moderate anxiety 36 and above: Severe anxiety Unit of Measure: Total score on the BAI.
All statistical analyses were performed in R (v4.3) using:
- ordinal: for modeling with a mixed ordinal regression approach
- em means: for post hoc comparisons
- MuMIn: for model fit metrics
- ggplot2: for graphical display of results
Measured: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
Secondary outcomes (6)
Effectiveness of the TET (Tion-Emo) technique for the control of depression
Measured using the Questionnaire: "Evaluating the Effectiveness of TET" developed by the principal investigator and reviewed by two psychologists. The questionnaire consists of 12 items, each rated on a Likert scale ranging from 0 (not at all) to 10 (completely). will be summarized as percentages for each response category and analyzed for trends.
Measured: Assessments conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
Effectiveness of the TET (Tion-Emo) technique in regulating anxiety
Measured using the Questionnaire: "Evaluating the Effectiveness of TET", developed by the principal investigator and reviewed by two psychologists. The questionnaire consists of 12 items, each rated on a Likert scale ranging from 0 (not at all) to 10 (completely). will be summarized as percentages for each response category and analyzed for trends.
Measured: Assessments conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group
Belief in the hypothesis of the core of emotions, this includes evaluating agreement with the statement: "All social emotions stem from the core of emotion."
Measured by: "The questionnaire to evaluate the effectiveness of TET". Answers to all questions were evaluated on a Likert scale ranging from 0 (not at all) to 10 (completely). Data will be summarized as percentages for each response category and analyzed for trends.
Measured: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
1. Ease of using the TET technique
Measured by: "The questionnaire to evaluate the effectiveness of TET". Answers to all questions, were evaluated on a Likert scale ranging from 0 (not at all) to 10 (completely). Data will be summarized as percentages for each response category and analyzed for trends.
Measured: 4. Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
2. Ease of learning the TET technique
Measured by: "The questionnaire to evaluate the effectiveness of TET". Answers to all questions, were evaluated on a Likert scale ranging from 0 (not at all) to 10 (completely). Data will be summarized as percentages for each response category and analyzed for trends.
Measured: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
3. General helpfulness of the TET technique
Measured by: "The questionnaire to evaluate the effectiveness of TET". Answers to all questions, were evaluated on a Likert scale ranging from 0 (not at all) to 10 (completely). Data will be summarized as percentages for each response category and analyzed for trends.
Measured: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start14 Sep 2023
- Primary completion23 Feb 2024
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive and Anxiety DisordersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafael Navia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafael Navia, TET Institute for development of psychotherapy and artificial emotion
- Investigators
- Rafael Navia, Principal investigator, No afiliado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950970
- Sponsor's protocol ID
- TET Institute
- Acronym
- TET
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data without breaking anonymity
Publications
Salvatore S, Tschacher W, Gelo OC, Koch SC. Editorial: Dynamic systems theory and embodiment in psychotherapy research. A new look at process and outcome. Front Psychol. 2015 Jul 1;6:914. doi: 10.3389/fpsyg.2015.00914. eCollection 2015. No abstract available.
PubMed 26191023Gilbert DT, Giesler RB, Morris KA. When comparisons arise. J Pers Soc Psychol. 1995 Aug;69(2):227-36. doi: 10.1037//0022-3514.69.2.227.
PubMed 7643304Spurio MG. The new functional identity: a body that thinks, a mind that feels - Frontiers and unexplored territories of the "Body and Mind zone". Psychiatr Danub. 2016 Sep;28(Suppl-1):111-115.
PubMed 27663819
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Tion-Emo Therapy and Technique as a New Treatment Option for Depression and Anxiety
- ClinicalTrials.gov ID
- NCT06950970
- Acronym / sponsor ID
- TET / TET Institute
- Conditions
- Depressive and Anxiety Disorders
- Keywords
- Objects, Therapy, comparison, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rafael NaviaUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 30 Apr 2025 (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 goal of this clinical trial is to explore the new therapy Cion-Emo therapy (TET) and to see if this technique is effective for treating depression and anxiety. Does TET lower anxiety and depression as participants learn and use this therapy? Researchers will compare TET with a control group to see if TET works in treating depression and anxiety. There was a pre-test and a post-test for both groups, experimental and control, and questionnaires to evaluate the effectiveness of TET. There was also a question to evaluate the hypothesis of the existence of nucleon emotion. The experimental group received TET therapy and techniques on an average of 10 to 12 one-hour sessions per week. The control group visited the clinic three times: in the first week all participants were evaluated to ascertain whether they were suffering from anxiety and depression; the second time was for the pre-test; and the third time was for the post-test.
Detailed description
The TION-EMO theory (TET) was developed in Finland approximately four decades ago with positive results in the public and private sectors. Positive results were also seen in Ecuador. The psychological system is divided into three regions: the first is a self-survival region to regulate all emotions connected with survival. For example, when a person wants to avoid getting contaminated with COVID-19, the survival region is activated in to avoid contracting the disease. Another clear example occurs when people see a tiger- the first thing they want to do is escape. This example of survival mechanism is good; however, the bad effect is that in many cases the self-survival emotions remain long after the incident has occurred, causing a negative effect on health. Depression and anxiety are mostly affected by the social region- the area connected with humans' relations with the people they meet. Finally, people have the intellectual region. The author discovered that when people imagine themselves feeling their own body, they automatically make direct contact with the self-survival region. In the case of self-survival anxiety, people can imagine the object which is causing anxiety. Lately, investigators have noticed that people do not need this self-survival object because it does not have any responsibility. TET therapy addresses this self-survival object through supervised guidance by trained therapists. All this guidance has a very special effect on people's moods. In the case of anxieties and depressions caused by the social region, people imagine the self-object, that is, the individual plus the social object that is causing the anxiety or depression plus the supporting words, which can only be understandable phrases agreed upon by the patient and taught by the therapist. This process takes three to four sessions to understand the logic of the therapy. Several authors consider human objects to be important in the development of emotions, as well as their cognitive components in the comparison of the two. The research will focus on demonstrating that people who use the CION-EMO technique can regulate the symptoms of anxiety and depression caused by conflict and stress. This research is highly desirable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm: "Patients receiving the investigational TET therapy and technique ." | Experimental | Behavioral: Tion-Emo therapy and technique for depression and anxiety ImprovementThe experimental group received the TET therapy and technique based on its theoretical framework between 10 and 12 sessions for one hour each. |
| Treatment Arm: "Patients not receiving the investigational TET therapy." | No intervention | –The patients did not receive any treatment, only pre-test and post-test. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tion-Emo therapy and technique for depression and anxiety ImprovementFrom 10 a 12 sessions once a week and one hour each session , for a positive result and development it is necessary to practice the technique | Behavioural | Treatment Arm: "Patients receiving the investigational TET therapy and technique ." |
Primary outcome
Reduction of depressive symptoms
Time frame: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
Assessment of the severity of depressive symptoms using the Beck Depression Inventory II (BDI-II), a self-report questionnaire with 21 items, each scored from 0 to 3. The total score ranges from 0 to 63, with interpretive ranges defined as: 0-13: Minimal depression 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression Unit of Measure: Total score on the BDI-II. All statistical analyses were performed in R (v4.3) using: * ordinal: for modeling with a mixed ordinal regression approach * emmeans: for post hoc comparisons * MuMIn: for model fit metrics * ggplot2: for graphical display of results
Improvement in anxiety symptoms
Time frame: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
Measured using the Beck Anxiety Inventory (BAI), a self-report questionnaire consisting of 21 questions. Each item is scored from 0 to 3, yielding a total score range of 0 to 63. The suggested cut-off points for anxiety levels are: 0-21: Very low anxiety 22-35: Moderate anxiety 36 and above: Severe anxiety Unit of Measure: Total score on the BAI. All statistical analyses were performed in R (v4.3) using: * ordinal: for modeling with a mixed ordinal regression approach * em means: for post hoc comparisons * MuMIn: for model fit metrics * ggplot2: for graphical display of results
6 secondary outcomes
Effectiveness of the TET (Tion-Emo) technique for the control of depression
Time frame: Assessments conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
Effectiveness of the TET (Tion-Emo) technique in regulating anxiety
Time frame: Assessments conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group
Belief in the hypothesis of the core of emotions, this includes evaluating agreement with the statement: "All social emotions stem from the core of emotion."
Time frame: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
1. Ease of using the TET technique
Time frame: 4. Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
2. Ease of learning the TET technique
Time frame: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
3. General helpfulness of the TET technique
Time frame: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group
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 30 Apr 2025.
- Background: PubMed 26191023Salvatore S, Tschacher W, Gelo OC, Koch SC. Editorial: Dynamic systems theory and embodiment in psychotherapy research. A new look at process and outcome. Front Psychol. 2015 Jul 1;6:914. doi: 10.3389/fpsyg.2015.00914. eCollection 2015. No abstract available.
- Background: PubMed 7643304Gilbert DT, Giesler RB, Morris KA. When comparisons arise. J Pers Soc Psychol. 1995 Aug;69(2):227-36. doi: 10.1037//0022-3514.69.2.227.
- Background: PubMed 27663819Spurio MG. The new functional identity: a body that thinks, a mind that feels - Frontiers and unexplored territories of the "Body and Mind zone". Psychiatr Danub. 2016 Sep;28(Suppl-1):111-115.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data without breaking anonymity
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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.
Rafael Navia principal investigator
No afiliado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tion-Emo therapy and technique for depression and anxiety Improvement in people with Depressive and Anxiety Disorders, run by Rafael Navia at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Apr 2025. 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 Ecuador. 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?
Reduction of depressive symptoms (time frame: Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.). 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 NCT06950970, which also lists 3 linked publications.
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 30 Apr 2025.