Group Therapy Using the I-Reconstruction Psychotherapy Method for Reducing Anxiety Levels: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in anxiety level on the Beck Anxiety Inventory (BAI) from baseline to 12 months after therapy
研究概览
简要总结
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.
详细描述
RESEARCH PROTOCOL (CONSORT) Title Group Therapy using the I-Reconstruction Psychotherapy Method for Anxiety Reduction: A Randomized Controlled Trial.
- Rationale Anxiety disorders remain one of the most widespread forms of mental pathology, significantly reducing the quality of life and social functioning of millions of people worldwide. Despite the recognized efficacy of Cognitive Behavioral Therapy (CBT) and pharmacological treatment as empirically supported approaches, a significant percentage of patients do not achieve full remission, and the treatment gap remains critically large. This underscores the necessity for finding and empirically testing new, deep-rooted psychotherapeutic interventions. This is where the I-Reconstruction psychotherapy method becomes relevant.
The I-Reconstruction method is a new but promising approach that offers a unique perspective on personality structure and the genesis of anxiety disorders. Central to the method are desire, possession, and satisfaction, which are viewed not merely as mental states but as fundamental structural elements of the personality that shape its interaction with the world. Dysfunctions or conflicts within these elements-specifically, impaired capacity to possess one's own emotional and life resources or the frustration of desire-directly lead to the formation of anxiety.
From the perspective of modern psychology, the inability to achieve satisfaction or unfulfilled desire are often catalysts for anxiety and pathological fixation. Researchers emphasize that impairments in self-regulation processes, including the capacity for adequate desire and the attainment of satisfaction, are closely linked to the development of a wide range of mental disorders, including anxiety. Specifically, issues with self-esteem and the possession of internal states often manifest as generalized anxiety and avoidance, highlighting the need for psychotherapeutic intervention aimed at these deeper structures. While CBT focuses on cognitive and behavioral patterns, I-Reconstruction aims for deeper change by restoring the integration of desire and possession as a healthy foundation for obtaining satisfaction, which is theoretically expected to yield a more stable reduction in anxiety levels.
Contemporary empirical studies confirm the link between this triad and the emergence of anxious symptoms. For instance, within Self-Determination Theory, the frustration of basic needs for autonomy and competence-i.e., the disruption of the sense of agency and possession over one's own actions-correlates with heightened anxiety and reduced psychological well-being. This mechanism demonstrates that the lack of experience in "possessing" one's own desires or internal states can intensify feelings of helplessness and loss of control-core characteristics of anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Active "I-Reconstruction" Therapy Group 1
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.
干预措施: Experimental: Active "I-Reconstruction" Therapy (Drug)
Active "I-Reconstruction" Therapy Group 2
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.
干预措施: Experimental: Active "I-Reconstruction" Therapy (Drug)
Control Group
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.
干预措施: Standard Care (Treatment as Usual) (Drug)
结局指标
主要结局
Change in anxiety level on the Beck Anxiety Inventory (BAI) from baseline to 12 months after therapy
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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))
研究者
Tetiana Pavlenko
Research Director, author of the "I - reconstruction" method, Supervisor
International Association Psychosomatics And Health Therapy