Group Therapy Using the I-Reconstruction Psychotherapy Method for Reducing Anxiety Levels: a Randomized Controlled Trial

NCT07397429 NA RECRUITING

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.

Details

Lead sponsor	International Association Psychosomatics And Health Therapy
Phase	NA
Status	RECRUITING
Enrolment	36
Start date	2026-03-02
Completion	2027-06

Conditions

• Anxiety
• Anxiety Depression

Interventions

• Experimental: Active "I-Reconstruction" Therapy
• Standard Care (Treatment as Usual)

Primary outcomes

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

Countries

Ukraine