About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Painhunting Therapy
- Cognitive Behavioural Therapy (CBT)