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临床试验/NCT06863948
NCT06863948已完成不适用

Pilot Randomized Controlled Trial of an Integrative Group Psychotherapy (Terebenin's Method) in Adults With Subclinical and Mild/Moderate Anxiety and Depression

S.LAB (SOLOWAYS)1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Depression Scores

研究概览

简要总结

Title Pilot Randomized Controlled Trial of an Integrative Group Psychotherapy (Terebenin's Method) in Adults with Subclinical and Mild/Moderate Anxiety and Depression

Summary and Detailed Description (Single Text Block) Anxiety and depression are significant public health concerns, with the World Health Organization (WHO) estimating that depression affects over 280 million people worldwide. Anxiety disorders frequently co-occur with depression, creating additional burdens on individuals and society. Integrative psychotherapeutic approaches-which combine elements from psychodrama, family systemic methods, Gestalt therapy, and body-oriented techniques-have shown efficacy in mild to moderate depression, often matching or exceeding outcomes of single-orientation therapies.

Terebenin's Method is an integrative group psychotherapy that actively uses psychodrama-based enactments, systemic constellation exercises, body-oriented practices, and a directive therapeutic style, aiming to help participants gain insight into maladaptive or unconscious patterns and reduce anxiety and depressive symptoms. To objectively measure the impact of this intervention, salivary cortisol (a marker of hypothalamic-pituitary-adrenal axis activity) and salivary alpha-amylase (reflecting sympathetic nervous system activation) will be assessed. These biomarkers can help validate reported symptom improvements by capturing shifts in stress reactivity.

This pilot trial adopts a randomized (1:1), controlled, prospective design, enrolling 60 adults aged 18-60 with mild, moderate, or subclinical anxiety/depressive symptoms. Participants will be randomized to one of two arms: an 8-week Terebenin's Method group (1 session/week, 2-3 hours per session) or a control group that either receives a standard form of psychotherapy (active control) or is waitlisted (if an active control is not feasible). Assessors who administer rating scales or process saliva samples will remain blinded to group assignments.

Inclusion criteria include the ability to attend weekly sessions and adhere to saliva sampling procedures, with stable or no psychotropic medication use. Individuals with severe psychiatric disorders, acute suicidal risk, or other confounding factors (e.g., significant substance use, concurrent ongoing psychotherapy) will be excluded. Because this is a pilot study, each arm will have 30 participants (total n=60), providing initial data on feasibility, effect sizes, and biomarker changes.

Primary outcomes-depression (BDI-II or HAM-D) and anxiety (STAI or HADS-A)-will be assessed at baseline (T0), post-intervention (T1, ~8 weeks), and follow-up (T2, ~1-3 months). Secondary outcomes include quality of life (WHOQOL-BREF or SF-36), perceived stress (PSS), and therapeutic alliance (WAI). Salivary cortisol and alpha-amylase will be collected at three time points across two consecutive days (upon awakening, 30 minutes after awakening, and in the evening) at T0, T1, and T2. Analyses will focus on the cortisol awakening response (CAR) and area under the curve (AUC) for both biomarkers.

Data will be managed in a secure database with unique participant IDs. A repeated-measures ANOVA or mixed-effects model will be used to analyze changes in clinical and biomarker data from baseline to follow-up between the two groups. If normality assumptions are violated, nonparametric methods may be employed. Missing data will be handled by intent-to-treat principles (e.g., multiple imputation or last observation carried forward).

Overall, this pilot trial aims to: (1) demonstrate whether Terebenin's Method leads to greater reductions in anxiety and depressive symptoms compared to the control, (2) examine changes in objective stress biomarkers, and (3) refine the methodology and effect size estimates for a larger, fully powered randomized controlled trial.

详细描述

Anxiety and depression are among the most prevalent mental health disorders worldwide, often presenting with overlapping symptoms that amplify the burdens on affected individuals and healthcare systems. According to the World Health Organization (WHO), depression alone affects over 280 million people globally (approximately 3.5% of the population). Anxiety disorders share a similar high prevalence and frequently co-occur with depressive conditions. In response to these challenges, diverse psychotherapy modalities have emerged, including integrative approaches that combine principles from different schools (e.g., psychodrama, Gestalt, family systemic, and body-oriented methods) to enhance treatment effectiveness. Meta-analyses indicate that these integrative strategies can achieve effect sizes (Cohen's d) in the range of 0.60-0.90, making them viable-or in some cases superior-alternatives to single-orientation therapies for mild to moderate depression ].

Within this integrative framework, Terebenin's Method stands out as a structured group intervention designed to address subclinical, mild, or moderate anxiety and depression. Its core elements include psychodrama-inspired enactments (allowing participants to "act out" internal conflicts or emotional challenges in a safe group context), systemic constellation techniques (focusing on relational and family-system dynamics through phenomenological exploration), body-oriented practices (emphasizing awareness of somatic tension and facilitating emotional expression), and a directive therapeutic style (where the therapist actively interprets and guides group processes) . The method posits that enacting and witnessing others' enactments of unconscious or maladaptive patterns facilitates emotional insight and symptom reduction, concurrently reinforcing self-esteem, resilience, and a sense of control.

Besides patient-reported outcomes, growing attention has turned to physiological markers that can provide objective evidence of treatment efficacy. Salivary cortisol (CORT) is widely recognized as an indicator of hypothalamic-pituitary-adrenal (HPA) axis function, known to rise under chronic stress, depressive episodes, and anxiety conditions. Likewise, salivary alpha-amylase (sAA) reflects sympathetic nervous system (SNS) activation and tends to increase during acute stress. Research suggests that effective psychotherapies can lower or normalize these biomarkers, thereby validating clinical improvements captured through self-report and observer-rated scales.

Against this background, the present study is designed as a pilot randomized controlled trial (1:1 allocation) to evaluate the effects of Terebenin's Method in individuals aged 18-60 who exhibit subclinical to moderate anxiety or depressive symptoms. The study will enroll approximately 60 participants (30 per group), enabling the collection of feasibility data and effect size estimates to inform a larger, fully powered RCT. Participants will be randomly assigned to one of two arms: (1) an 8-week course of integrative group therapy using Terebenin's Method (weekly sessions of 2-3 hours, led by 1-2 trained facilitators with a group size of 8-12), or (2) a control condition that may consist of an active psychotherapeutic intervention (e.g., short-term cognitive-behavioral therapy or Gestalt group) conducted on a similar 8-week schedule, or a waitlist if the active control is not feasible.

Inclusion criteria require stable or no psychotropic medication use, absence of severe psychiatric disorders or acute suicidal risk, the ability to attend weekly sessions, compliance with saliva sampling, and written informed consent. Exclusion criteria encompass severe somatic illnesses preventing participation, current psychotherapy likely to confound results, and active substance use disorders unless in stable remission for more than six months.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18-
  • •Subclinical, mild, or moderate anxiety/depressive symptoms (screened via HADS, BDI-II, STAI).
  • •No current psychotropic medication use or on a stable dose for ≥4 weeks with no planned changes.
  • •Ability to attend weekly group sessions for 8 weeks + follow-up visits, including saliva sample collection.
  • •Provision of written informed consent.

排除标准

  • •Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder in a manic phase, major depression with psychotic features).
  • •Significant suicidal risk requiring urgent intervention.
  • •Severe somatic illness impeding participation.
  • •Active substance use disorder unless in stable remission for >6 months.
  • •Ongoing psychotherapy that could confound results.
  • •Inability to comply with saliva collection (e.g., shift work, severe sleep disturbances).

研究组 & 干预措施

Intervention: "Terebenin's Method"

Experimental

干预措施: Teribenin method (Other)

Control Interventions

Active Comparator

干预措施: Control Interventions (Other)

结局指标

主要结局

Depression Scores

时间窗: 3 months

The Beck Depression Inventory-II is a 21-item self-report scale measuring the severity of depressive symptoms. Each item is scored from 0 to 3, with total scores ranging from 0 (no depression) to 63 (severe depression). Higher scores indicate a worse outcome .

Anxiety Score

时间窗: 3 months

The State-Trait Anxiety Inventory contains two 20-item subscales assessing state anxiety and trait anxiety. Each item is scored from 1 to 4, leading to subscale scores ranging from 20 to 80. Higher scores indicate a worse outcome (i.e., higher levels of anxiety).

次要结局

  • Salivary Alpha-Amylase(3 months)
  • Quality of Life / Well-Being(3 months)
  • Perceived Stress(3 months)
  • Therapeutic Alliance(3 months)
  • Salivary Cortisol (CORT):(3 months)

研究者

发起方
S.LAB (SOLOWAYS)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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