Integrative Group Psychotherapy (Terebenin's Method) in Adults With Subclinical and Mild/Moderate Anxiety and Depression

Summary

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.

Conditions

• Anxiety
• Depression - Major Depressive Disorder

Interventions

OTHER

Teribenin method

Intervention: "Terebenin's Method" * Format: * Duration: 8 weeks, 1 session/week (2-3 hours). * Group size: 8-12 participants + 1-2 facilitators. * Structure of Each Session: * Introduction (10-15 min): Check-in, brief emotional reflection. * Main Phase (90-120 min): Psychodrama-like enactments, systemic constellation exercises, body-oriented practices, directive interpretation by the therapist. * Conclusion (15-20 min): Group reflection, integration, feedback. * Quality Assurance: * Audio/video recording (with consent) for supervision. * A standard protocol/manual specifying core techniques

OTHER

Control Interventions

1\. Active Control (Preferred): * Group psychotherapy (CBT, Gestalt, or another recognized approach) matching the same 8-week schedule. 2. Waitlist Control (If Active Control Unavailable): * Participants receive no active intervention during the 8 weeks, then are offered therapy afterward (if applicable)

Sponsors & Collaborators

• Center for New Medical Technologies, Novosibirsk, Russia

  collaborator OTHER

• S.LAB (SOLOWAYS)

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-30

Primary Completion

2025-08-15

Completion

2025-10-12

Countries

• Russia

Study Locations