Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression

NCT07738146 | Not Yet Recruiting

• 1 other identifier: IRB-2167
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Depression - Major Depressive Disorder

Keywords

painhunting; painhunting therapy; CBT; event-related depression; depression; psychotherapy; Cognitive Behavioral Therapy; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)

  Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, each scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms. The primary comparison between treatment groups will evaluate PHQ-9 scores at six weeks post-randomization, adjusting for baseline PHQ-9.

  6 weeks post-randomization

Secondary Outcomes (10)

• Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)

  2 weeks and 10 to 12 weeks post-randomization

• Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7)

  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)

  Baseline, 6 weeks, and 10 to 12 weeks post-randomization

• Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG)

  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)

  Baseline, 6 weeks, and 10 to 12 weeks post-randomization

Other Outcomes (3)

• Painhunting mechanism recognition across treatment sessions

  Across Painhunting treatment sessions, approximately 2 to 4 weeks

• Therapeutic alliance measured by the Working Alliance Inventory - Short Form

  Session 2 and Session 4 (Week 1 and Week 2)

• Per-session trajectory of depressive symptoms measured by PHQ-9

  1 to 2 days after each treatment session during the active treatment period (Week 1-3)

Study Arms (2)

Painhunting Therapy

EXPERIMENTAL

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)

Interventions

Painhunting Therapy BEHAVIORAL

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.

Painhunting Therapy

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Painhunting LLP: lead

Study Sites (1)

Central Painhunting Office

Astana, Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

olzhas seitov, MSc

CONTACT

+77017636166; seitov.ok@gmail.com

Sanemkhan Uzakova, MSc, MD

CONTACT

+7 701 519 3305; sanemkhan1977@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors administering assessments at T2, T3, and T4 are blinded to treatment allocation. Participants and treating therapists are not blinded due to the nature of the psychotherapeutic interventions. Statistical analyses are performed using blinded group coding until the primary analysis is locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Endocrinologist

Model Details: Participants are randomized 1:1 to Painhunting Therapy or Cognitive Behavioural Therapy. The trial uses an adaptive design with an initial cohort of 30 participants (15 per arm) and planned continuation to a total analyzed sample of 60 participants (30 per arm), unless a prespecified stopping criterion is met.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and supporting materials will become available concurrent with publication of the primary study results and will remain available indefinitely.
• Access Criteria: De-identified data and supporting materials will be publicly available through the Open Science Framework (OSF).

Locations

KA (1)