Online group I-Reconstruction psychotherapy to reduce anxiety
Group Therapy Using the I-Reconstruction Psychotherapy Method for Reducing Anxiety Levels: a Randomized Controlled Trial
This trial tests whether a 10-week online group course using the I-Reconstruction method can help adults with anxiety feel less anxious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | International Association Psychosomatics And Health Therapy Academic / other |
| Locations | 1 site (Kyiv, Kyiv Oblast) |
| Trial ID | NCT07397429 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares an experimental group that receives 10 weekly online I-Reconstruction group therapy sessions with a control group receiving usual care. Sessions combine guided breathing and movement exercises with therapist-led group discussion focused on desire, possession, and satisfaction as drivers of anxiety. Outcomes include standard anxiety scales and quality-of-life measures collected at baseline and at 3, 6, and 12 months after the intervention. Participants are screened for clinically significant anxiety and specific preverbal dysregulation profiles and must not be in concurrent psychotherapy or recently on psychotropic medication.
Who should consider this trial
Good fit: Adults aged 18–55 with clinically significant anxiety (BAI ≥ 9 and HADS-A ≥ 11) and specified preverbal dysregulation scores who can attend online group sessions and are not currently in psychotherapy or on psychotropic medication are ideal candidates.
Not a fit: People with severe mental disorders, recent use of psychotropic drugs, concurrent psychotherapy, those outside the 18–55 age range, or those who do not meet the specific dysregulation screening scores are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the method could lower anxiety symptoms and improve quality of life for participating adults, potentially with lasting effects up to a year.
How similar studies have performed: While group psychotherapies and several psychotherapeutic approaches have evidence for anxiety reduction, the I-Reconstruction method is novel and lacks prior randomized controlled trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). Failure to meet any of the threshold values specified in the inclusion criteria.
Where this trial is running
Kyiv, Kyiv Oblast
- International Association of Psychosomatics and Body Therapy — Kyiv, Kyiv Oblast, Ukraine (Recruiting)
Study contacts
- Principal investigator: Tetiana Pavlenko — International Association of Psychosomatics and Health Therapy
- Study coordinator: Tetiana Pavlenko
- Email: tanjapavlenko28223@gmail.com
- Phone: +380976953203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.