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Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression
Sponsor: Painhunting LLP
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.
Official title: Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09-01
Completion Date
2027-04-30
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
Painhunting Therapy
Painhunting Therapy is a structured psychotherapeutic intervention targeting event-related distress through a standardized treatment protocol. 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.
Cognitive Behavioural Therapy (CBT)
Manualized Cognitive Behavioural Therapy for depression delivered over 6 to 8 sessions at approximately twice-weekly frequency. Treatment is delivered by independent CBT practitioners who meet prespecified training and competence requirements and are not affiliated with the Painhunting practice or training programme.
Locations (1)
Central Painhunting Office
Astana, Astana, Kazakhstan