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

NCT06863948 | Completed DMC

• 1 other identifier: SW023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

deprssion; anxiety; psychotherapy; cortisol

Outcome Measures

Primary Outcomes (2)

• Depression Scores

  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 .

  3 months

• Anxiety Score

  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).

  3 months

Secondary Outcomes (5)

• Quality of Life / Well-Being

  3 months

• Perceived Stress

  3 months

• Therapeutic Alliance

  3 months

• Salivary Cortisol (CORT):

  3 months

• Salivary Alpha-Amylase

  3 months

Study Arms (2)

Intervention: "Terebenin's Method"

EXPERIMENTAL

Other: Teribenin method

Control Interventions

ACTIVE COMPARATOR

Other: Control Interventions

Interventions

Teribenin method OTHER

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

Intervention: "Terebenin's Method"

Control Interventions OTHER

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)

Control Interventions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-60.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center for New Medical Technologies, Novosibirsk, Russia: collaborator

Study Sites (1)

Center for New Medical Technologies

Novosibirsk, 630090, Russia

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 7, 2025
• Study Start: May 30, 2024
• Primary Completion: August 15, 2025
• Study Completion: October 12, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)