Evaluating the Effectiveness of Tion-Emo Therapy and Technique (TET)

NCT06950970 | Completed

• 1 other identifier: TET Institute
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Depressive and Anxiety Disorders

Keywords

Objects, Therapy, comparison; Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

  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."

  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

  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

  Assessments will be conducted at baseline and 12 weeks post-treatment (pre-test and post-test), including comparisons with a control group.

Study Arms (2)

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.

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.

Interventions

Tion-Emo therapy and technique for depression and anxiety Improvement BEHAVIORAL

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

Treatment Arm: "Patients receiving the investigational TET therapy and technique ."

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Substance abuse or dependency, evaluated in the screaning interview.
• Severe neurological impairment or cognitive disorder, that may limit participation and affect the study outcomes.

Sponsors & Collaborators

• Rafael Navia: lead

Study Sites (1)

TET institute for development of psychotherapy and artificial emotion

Portoviejo, Manabí, 130102, Ecuador

Location

Related Publications (3)

• 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.

  PMID: 26191023 BACKGROUND

• 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.

  PMID: 7643304 BACKGROUND

• 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.

  PMID: 27663819 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rafael Navia

  No afiliado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 30, 2025
• Study Start: September 14, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 8, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deadline: Data requests can be submitted starting nine months after the article's publication and will be available for up to 24 months. Extensions are considered on a case-by-case basis.
• Access Criteria: Qualified researchers conducting independent scientific research may request access to clinical trial research information (CRI). This access will be provided upon review and approval of a research proposal and Statistical Analysis Plan (SAP) and the signing of a Data Sharing Agreement (DSA). For more information or to submit a request.

Locations

EC (1)