Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression

The purpose of this study is to compare the effectiveness of Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT), an established psychological treatment for depression, in adults experiencing depressive symptoms associated with adverse life events.

Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The Painhunting Therapy arm will receive a brief structured course of therapy, with a minimum planned dose of three sessions except for participants meeting prespecified early-remission criteria, and additional sessions permitted when clinically indicated. The CBT arm will receive manualized CBT for depression delivered over approximately six to eight sessions. The intended primary treatment comparison is approximately three Painhunting sessions versus six CBT sessions, reflecting the typical delivery format of each intervention rather than a matched-dose comparison.

The primary endpoint is PHQ-9 score at six weeks after randomization. Additional assessments will examine depressive symptoms at earlier and later time points, anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and maintenance of outcomes at 10 to 12 weeks.

Outcome assessments at key follow-up time points will be conducted by assessors blinded to treatment allocation. Treatment adherence and fidelity will be independently assessed in both treatment arms using prespecified treatment-specific rating instruments.

The trial will initially enroll 30 participants, with 15 participants per treatment arm. An interim analysis and prespecified adaptive sample-size procedure will determine continuation toward a planned final analyzed sample of 60 participants, with 30 participants per arm, unless a prespecified stopping criterion is met.

• Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 2 weeks and 10 to 12 weeks post-randomization]
• Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization]
• Event-related distress measured by the Impact of Event Scale-Revised (IES-R) [Срок оценки: Baseline, 6 weeks, and 10 to 12 weeks post-randomization]
• Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG) [Срок оценки: Baseline, 6 weeks, and 10 to 12 weeks post-randomization]
• Functional impairment measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0) [Срок оценки: Baseline, 6 weeks, and 10 to 12 weeks post-randomization]
• Treatment response based on PHQ-9 [Срок оценки: 6 weeks and 10 to 12 weeks post-randomization]
• Remission based on PHQ-9 [Срок оценки: 6 weeks and 10 to 12 weeks post-randomization]
• Number of treatment sessions received [Срок оценки: From treatment initiation through completion of the active treatment period, approximately 4 weeks]
• Treatment and study dropout rate [Срок оценки: Through 10 to 12 weeks post-randomization]
• Protocol deviation rate [Срок оценки: Through 10 to 12 weeks post-randomization]