- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950970
Evaluating the Effectiveness of Tion-Emo Therapy and Technique (TET) (TET)
Assessing the Effectiveness of Tion-Emo Therapy and Technique as a New Treatment Option for Depression and Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manabi
-
Portoviejo, Manabi, Ecuador, 130102
- TET institute for development of psychotherapy and artificial emotion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Arm: "Patients receiving the investigational TET therapy and technique ."
The experimental group received the TET therapy and technique based on its theoretical framework between 10 and 12 sessions for one hour each.
|
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
|
|
No Intervention: Treatment Arm: "Patients not receiving the investigational TET therapy."
The patients did not receive any treatment, only pre-test and post-test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
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
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:
|
Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
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.
|
Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafael Navia, No afiliado
Publications and helpful links
General 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.
- Gilbert 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.
- Spurio 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TET Institute
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Study Data/Documents
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Informed Consent Form
Information identifier: tetinstitute.rn@gmail.com
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Statistical Analysis Plan
Information identifier: tetinstitute.rn@gmail.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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