Group Therapy Using the "I-Reconstruction" Psychotherapy Method to Reduce Anxiety Levels

NCT07397429 | Recruiting

• 1 other identifier: Onorul88
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary of the Study The aim of this clinical trial is to find out if the group therapy method "Self-Reconstruction" helps to reduce anxiety in adults. The researchers want to see if the participants' emotional state becomes more stable after completing the course. The main questions that this study aims to answer are: Do people's anxiety levels decrease after taking the course of "I-Reconstruction" classes? Do the positive effects of the classes persist 3, 6 and 12 months after they finish? Do the participants' quality of life and ability to enjoy life improve? The researchers will compare a group of people who attend the therapy classes with a group of people who receive usual care to see if the new method is more effective. Participants will: Participate in 10 online group meetings once a week. Do simple breathing and movement exercises to calm the body and emotions. Discuss your feelings and desires with a professional in a safe group. Complete questionnaires about your condition at the beginning, during, and after the study.

Conditions

Anxiety; Anxiety Depression

Keywords

Anxiety,; Group Therapy; Randomized Controlled Trial - RCT; Anxiety Disorders; Psychotherapeutic Intervention; Depression; I - Reconstruction; Internal Conflict Test; Preverbal trauma

Outcome Measures

Primary Outcomes (3)

• Change in anxiety level on the Beck Anxiety Inventory (BAI) from baseline to 12 months after therapy

  Total score on the Beck Anxiety Inventory (BAI). The scale consists of 21 items, where each item is rated from 0 to 3 points. The total score ranges from 0 to 63. A higher score indicates a higher level of anxiety (0-7: minimal, 8-15: mild, 16-25: moderate, 26-63: severe anxiety)

  T1: Baseline (before the intervention); T2: 5 weeks (mid-intervention); T3: 10 weeks (immediately after the intervention); T4: 22 weeks (3 months after the intervention); T5: 34 weeks (6 months after the intervention); T6: 60 weeks (12 months after)

• Change in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale scores from baseline to 12 months after therapy

  Total score for the HADS-A anxiety subscale. The subscale contains 7 questions, each of which is scored from 0 to 3 points. The total score ranges from 0 to 21. A higher score indicates a higher level of anxiety (0-7: normal, 8-10: subclinically expressed anxiety, 11-21: clinically expressed anxiety)

  T1: Baseline (before the intervention); T2: 5 weeks (mid-intervention); T3: 10 weeks (immediately after the intervention); T4: 22 weeks (3 months after the intervention); T5: 34 weeks (6 months after the intervention); T6: 60 weeks (12 months after)

• Change in total score according to the "I - Reconstruction" diagnosis of preverbal dysregulation (DPD) method from baseline to 12 months after therapy

  A general measure of the level of preverbal trauma, including three scales: possession, pleasure, and desire. Each scale contains 3 questions. The total score ranges from 0 to 45. A higher score indicates a higher degree of severity of preverbal trauma

  T1: Baseline (before the intervention); T2: 5 weeks (mid-intervention); T3: 10 weeks (immediately after the intervention); T4: 22 weeks (3 months after the intervention); T5: 34 weeks (6 months after the intervention); T6: 60 weeks (12 months after)

Secondary Outcomes (3)

• Change in depression scores on the Beck Depression Inventory (BDI) from baseline to 12 months after intervention

  T1: Baseline (before the intervention); T2: 5 weeks (mid-intervention); T3: 10 weeks (immediately after the intervention); T4: 22 weeks (3 months after the intervention); T5: 34 weeks (6 months after the intervention); T6: 60 weeks (12 months after)

• Change in Hospital Anxiety and Depression Scale (HADS-D) Depression subscale scores from baseline to 12 months post-intervention

  T1: Baseline (before the intervention); T2: 5 weeks (mid-intervention); T3: 10 weeks (immediately after the intervention); T4: 22 weeks (3 months after the intervention); T5: 34 weeks (6 months after the intervention); T6: 60 weeks (12 months after)

• Change in the level of internal conflicts according to the "Internal Conflict Test" from baseline to 12 months after intervention

  T1: Baseline (before the intervention); T2: 5 weeks (mid-intervention); T3: 10 weeks (immediately after the intervention); T4: 22 weeks (3 months after the intervention); T5: 34 weeks (6 months after the intervention); T6: 60 weeks (12 months after)

Study Arms (3)

Active "I-Reconstruction" Therapy Group 1

EXPERIMENTAL

Participants randomized to the experimental group received the active psychotherapeutic intervention "l-Reconstruction." This group consisted of adults with clinically significant anxiety who met all inclusion criteria of the study. Participants attended ten weekly online group therapy sessions led by a certified "l-Reconstruction" therapist. The group format was designed to facilitate therapeutic change through guided interpersonal interaction, normalization of experiences, and reflection within a structured therapeutic framework. All participants in the experimental group completed baseline, post-intervention, and follow-up assessments to evaluate changes in anxiety and related psychological outcomes.

Drug: Experimental: Active "I-Reconstruction" Therapy

Active "I-Reconstruction" Therapy Group 2

EXPERIMENTAL

Participants randomized to the experimental group received the active psychotherapeutic intervention "l-Reconstruction." This group consisted of adults with clinically significant anxiety who met all inclusion criteria of the study. Participants attended ten weekly online group therapy sessions led by a certified "l-Reconstruction" therapist. The group format was designed to facilitate therapeutic change through guided interpersonal interaction, normalization of experiences, and reflection within a structured therapeutic framework. All participants in the experimental group completed baseline, post-intervention, and follow-up assessments to evaluate changes in anxiety and related psychological outcomes.

Drug: Experimental: Active "I-Reconstruction" Therapy

Control Group

OTHER

Standard Care (Treatment as Usual) Participants randomized to the control group received no therapeutic intervention during the study period. They continued with their usual daily activities and were not restricted from seeking any form of support or care outside the study. The control group participated only in scheduled psychological assessments at baseline, post-intervention, and follow-up time points, allowing for comparison of outcome trajectories between the intervention and non-intervention conditions.

Drug: Standard Care (Treatment as Usual)

Interventions

Experimental: Active "I-Reconstruction" Therapy DRUG

The intervention consisted of a structured group psychotherapy program based on the "l-Reconstruction" method. The program included ten weekly group sessions, each lasting 120 minutes, delivered online by a certified therapist trained in the method. The intervention targeted anxiety through therapeutic work with preverbal trauma and internal conflicts by reconstructing core personality components related to desire, ownership, and the capacity for pleasure. The therapeutic process combined psychoeducation, analysis of preverbal acts, exploration of emotional and bodily responses, reconstruction of traumatic experiential patterns, and structured group reflection and integration. The intervention followed a standardized protocol to ensure consistency across groups and therapists.

Also known as: I-Reconstruction

Active "I-Reconstruction" Therapy Group 1; Active "I-Reconstruction" Therapy Group 2

Standard Care (Treatment as Usual) DRUG

Participants assigned to the control group did not receive any structured psychotherapeutic intervention as part of the study. During the intervention period, no active treatment, group sessions, or therapeutic procedures were provided by the research team. The control condition was designed to serve as a non-intervention comparison group for evaluating the effects of the "l-Reconstruction" group psychotherapy.

Control Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 55 years (inclusive).
• Clinically significant level of anxiety according to the Beck Anxiety Inventory (BAI) ≥ 9 points.
• Anxiety subscale score on the Hospital Anxiety and Depression Scale (HADS-A) ≥ 11 points.
• Significant level of preverbal trauma according to the "Diagnostics of Preverbal Dysregulation" (DPD, T. Pavlenko) questionnaire: total score ≥ 16.
• Specific subscale scores in DPD: "Desire" ≥ 5, "Satisfaction" ≥ 5, and "Possession" (Obsession) ≥ 6 points.
• Presence of internal conflicts according to the "Internal Conflict Test" (ICT) ≥ 1 point on the skin tissue measurement scale.
• Willingness to comply with the study protocol and the online therapy format.

You may not qualify if:

• Current participation in any other psychotherapy during the study.
• Use of any psychotropic medications within the last 30 days (antidepressants, tranquilizers, neuroleptics, mood stabilizers).
• Diagnosed severe mental disorders (according to ICD-10/DSM-5) requiring specialized psychiatric care or inpatient treatment.
• Presence of acute suicidal risk.
• Substance abuse (alcoholism, drug addiction).

Sponsors & Collaborators

• International Association Psychosomatics And Health Therapy: lead

Study Sites (1)

International Association of Psychosomatics and Body Therapy

Kyiv, Kyiv Oblast, 03057, Ukraine

RECRUITING

Related Links

• Lifetime prevalence and distribution of mental disorders by age of onset in the World Health Organization's Global Mental Health Survey Initiative
• The global burden of mental disorders: updated data from the WHO World Mental Health Survey (WMH)
• World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for treatment of anxiety, obsessive-compulsive and posttraumatic stress disorders - Version 3. Part I: Anxiety disorders
• How Much Does Therapy Cost in Zurich? 2025 Guide
• Kernberg, O. F. (1993). The current status of psychoanalysis. Journal of the American Psychoanalytic Association, 41(1), 45-62.
• Retrospective Analysis of Mental Disorder Patients with "Combination of Medical Care and Nursing Care"
• The Mental Health Implications of a Local Epidemic: Early Experience with the COVID-19 Outbreak in Wuhan
• Anhedonia and anxiety underlying depressive symptomatology have distinct effects on reward-based decision-making
• Reconsidering anhedonia in depression: Lessons from translational neuroscience

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tetiana Pavlenko

  International Association of Psychosomatics and Health Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tetiana Pavlenko

CONTACT

+380976953203; tanjapavlenko28223@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention (an active, structured group psychotherapy "I-Reconstruction" compared to supportive group psychotherapy), full blinding of participants and therapists is not possible. However, to minimize the risk of bias and ensure methodological rigor, partial blinding will be applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, author of the "I - reconstruction" method, Supervisor

Model Details: A Randomized Controlled Trial with three parallel groups (2 experimental and 1 control). The duration of participation is 12 months (10-session core course + follow-up assessments at 3, 6, and 12 months). This study will be conducted online, based at the International Association of Psychosomatics and Body Therapy. Participant recruitment will be conducted via social media and the Association's online platforms.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 9, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Access to individual depersonalized participant data (IPD) and related supporting information may be provided to independent researchers after publication of the main results of the study in specialized scientific journals. Access will be granted exclusively on the basis of a substantiated scientific request, containing a clearly defined purpose of data use, an analysis plan and confirmation of compliance with ethical principles. The volume of accessible data will be limited to depersonalized sets of IPD and relevant methodological documentation (e.g. description of variables and study protocol). Data transfer will be carried out in accordance with applicable data exchange agreements and subject to full compliance with ethical and regulatory requirements that guarantee the confidentiality and protection of personal information of participants.

Locations

UA (1)