Health Trials

Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression

ConditionDepression - Major Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPainhunting LLP

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Painhunting TherapyExperimental treatment 1 intervention
Group B: Cognitive Behavioural Therapy (CBT)Active comparator 1 intervention

Trial outcomes

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.

Time frame
6 weeks post-randomization

Secondary 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 scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms.

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

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

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.

Time frame
Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization
3

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

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.

Time frame
Baseline, 6 weeks, and 10 to 12 weeks post-randomization
4

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

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.

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

Other outcomes

1

Painhunting mechanism recognition across treatment sessions

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.

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

Therapeutic alliance measured by the Working Alliance Inventory - Short Form

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.

Time frame
Session 2 and Session 4 (Week 1 and Week 2)
3

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

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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Painhunting LLP

Lead sponsor

Source ClinicalTrials.gov

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