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NCT07738146Not yet recruiting

Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression

Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
23 Jul 2026
Start date
1 Sept 2026
Primary completion date
28 Feb 2027
Lead sponsor
Painhunting LLP
Diseases
Depression
NCT number
NCT07738146

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Sept 2026 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Initiation of pharmacotherapy within the prior four weeks.

Other illness

  • Active substance use disorder meeting DSM criteria.

Other

  • 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.
  • Current psychotherapy with another provider.
  • Pre-existing stable antidepressant monotherapy unchanged for eight weeks or longer is permitted.
  • Inability to provide informed consent in Russian.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Central Painhunting Office
Coordinator of this site? Confirm its status
AstanaKazakhstanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.