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NCT Number: NCT07738146

Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression

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.

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Key information

Conditions

Depression - Major Depressive Disorder Behavior Behavioral Symptoms Depression

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 6 weeks post-randomization

    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.

Secondary outcomes

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

    Time frame: 2 weeks and 10 to 12 weeks post-randomization

    Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms.

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

    Time frame: Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization

    Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). The scale consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.

  3. Event-related distress measured by the Impact of Event Scale-Revised (IES-R)

    Time frame: Baseline, 6 weeks, and 10 to 12 weeks post-randomization

    Event-related distress will be assessed using the Impact of Event Scale-Revised (IES-R). The instrument contains 22 items rated from 0 to 4. Higher scores indicate greater severity of event-related distress.

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

    Time frame: Baseline, 6 weeks, and 10 to 12 weeks post-randomization

    Complicated grief symptoms will be assessed using the Inventory of Complicated Grief (ICG) only among participants in the prespecified bereavement/loss stratum, defined as participants whose qualifying index event is the death of a significant other. Participants outside this stratum will not complete the ICG. Higher scores indicate greater severity of complicated grief symptoms.

  5. Functional impairment measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0)

    Time frame: Baseline, 6 weeks, and 10 to 12 weeks post-randomization

    Functional impairment will be assessed using the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0). Higher scores indicate greater disability and functional impairment.

  6. Treatment response based on PHQ-9

    Time frame: 6 weeks and 10 to 12 weeks post-randomization

    Treatment response is defined as a reduction of 50% or greater in PHQ-9 score from baseline. The proportion of participants meeting the response criterion will be assessed by treatment arm.

  7. Remission based on PHQ-9

    Time frame: 6 weeks and 10 to 12 weeks post-randomization

    Remission is defined as a PHQ-9 score below 5. The proportion of participants meeting the remission criterion will be assessed by treatment arm.

  8. Number of treatment sessions received

    Time frame: From treatment initiation through completion of the active treatment period, approximately 4 weeks

    The total number of treatment sessions received by each participant during the active treatment period will be recorded and summarized by treatment arm.

  9. Treatment and study dropout rate

    Time frame: Through 10 to 12 weeks post-randomization

    The proportion of participants who discontinue treatment or study participation will be recorded and summarized by treatment arm and assessment timepoint.

  10. Protocol deviation rate

    Time frame: Through 10 to 12 weeks post-randomization

    The number and proportion of participants with documented protocol deviations will be summarized by treatment arm.

Other outcomes

  1. Painhunting mechanism recognition across treatment sessions

    Time frame: Across Painhunting treatment sessions, approximately 2 to 4 weeks

    Prespecified Painhunting treatment mechanisms will be assessed across sessions in participants assigned to the Painhunting arm using the Painhunting mechanism recognition checklist. A stratified sample of 20% of Painhunting session recordings will be independently rated to triangulate self-report against rater-coded mechanism content.

  2. Therapeutic alliance measured by the Working Alliance Inventory - Short Form

    Time frame: Session 2 and Session 4 (Week 1 and Week 2)

    Therapeutic alliance will be assessed in both treatment arms using the Working Alliance Inventory - Short Form (WAI-SF). The WAI-SF consists of 12 items rated on a 7-point Likert scale, yielding a total score ranging from 12 to 84. Higher scores indicate a stronger therapeutic alliance.

  3. Per-session trajectory of depressive symptoms measured by PHQ-9

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

    Depressive symptoms will be assessed 1 to 2 days after each treatment session 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. Scores will be collected after each treatment session in both treatment arms to characterize session-level symptom trajectories and dose-response patterns.

Study contacts

Contact information is provided by the study sponsor or research team.

Sanemkhan Uzakova, MSc, MD

CONTACT

[email protected]

+7 701 519 3305

olzhas seitov, MSc

CONTACT

[email protected]

+77017636166

Sponsors and collaborators

Lead sponsor

Painhunting LLP

Other

Registry information

Official study title

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

Acronym: PH-CBT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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