About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Experimental: Active "I-Reconstruction" Therapy
DrugThe 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.
Standard Care (Treatment as Usual)
DrugParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
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)
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
Secondary outcomes
Change in depression scores on the Beck Depression Inventory (BDI) from baseline to 12 months after intervention
Total score on the BDI-II questionnaire, consisting of 21 items. Each response is scored from 0 to 3 points. The total score ranges from 0 to 63. Higher scores indicate higher severity of depressive symptoms (0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe depression)
Change in Hospital Anxiety and Depression Scale (HADS-D) Depression subscale scores from baseline to 12 months post-intervention
Total score on the HADS-D depression subscale (7 questions). Each response is scored from 0 to 3 points. The total score ranges from 0 to 21. A higher score indicates a higher level of depressive symptoms (0-7: normal, 8-10: subclinical depression, 11-21: clinical depression)
Change in the level of internal conflicts according to the "Internal Conflict Test" from baseline to 12 months after intervention
In the "Internal Conflict Test" questionnaire, the indicator is measured in points. From 0 to 27. A higher score indicates a higher level of intensity of internal conflicts.
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Sponsors and contacts
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