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NCT07738146

Overview

NCT ID: NCT07738146
Lead Sponsor: Painhunting LLPOTHER
Official Title: Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation
Brief Summary: This randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. The primary outcome is depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) at six weeks after randomization. Secondary outcomes include anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and durability of outcomes at 10 to 12 weeks. The study will also assess treatment fidelity, therapeutic alliance, and selected potential moderators of treatment response. The trial uses a randomized, rater-blinded, parallel-group design with an adaptive sample-size approach.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Feb 28, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 18 years or older.

PHQ-9 score of 9 or greater at screening.

At least one adverse life event within the prior 24 months, documented using the Life Events Threshold (LTE) instrument.

Resident of Kazakhstan.

Fluent in Russian.

Capacity to provide written informed consent.

Willing to attend at least six sessions within the protocol treatment schedule.

Exclusion Criteria:

Active suicidal ideation requiring immediate referral, defined as PHQ-9 item 9 score of 3 or clinical judgment of imminent risk.

Active psychosis or mania.

Active substance use disorder meeting DSM criteria.

Current psychotherapy with another provider.

Initiation of pharmacotherapy within the prior four weeks.

Pre-existing stable antidepressant monotherapy unchanged for eight weeks or longer is permitted.

Inability to provide informed consent in Russian.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: olzhas seitov, MScContact
seitov.ok@gmail.com+77017636166

Similar Studies

Participant Group/Arms

Painhunting TherapyExperimental

Participants assigned to this arm will receive Painhunting Therapy, a structured psychotherapeutic intervention. The intended treatment dose is three sessions. Early stopping after session 2 is permitted only when prespecified remission criteria are met. Additional sessions, up to a maximum of six, may be provided according to prespecified symptom-based and clinical criteria.

Behavioral: Painhunting Therapy

Cognitive Behavioural Therapy (CBT)Active Comparator

Participants assigned to this arm will receive manualized Cognitive Behavioural Therapy (CBT) for depression, delivered over 6 to 8 sessions at approximately twice-weekly frequency. Treatment will be delivered by independent CBT practitioners who are not affiliated with the Painhunting practice or training programme.

Behavioral: Cognitive Behavioural Therapy (CBT)