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Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression (PH-CBT)

28. Juli 2026 aktualisiert von: Uzakova Sanemkhan, Painhunting LLP

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Kasachstan
    • Astana
      • Astana, Astana, Kasachstan, 010000
        • Central Painhunting Office
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Painhunting Therapy
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.
Verhalten: Painhunting Therapy
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.
Aktiver Komparator: Cognitive Behavioural Therapy (CBT)
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.
Verhalten: Cognitive Behavioural Therapy (CBT)
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: 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.
6 weeks post-randomization

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: 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 weeks and 10 to 12 weeks post-randomization
Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7)
Zeitfenster: 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.
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)
Zeitfenster: 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.
Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG)
Zeitfenster: 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.
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)
Zeitfenster: 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.
Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Treatment response based on PHQ-9
Zeitfenster: 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.
6 weeks and 10 to 12 weeks post-randomization
Remission based on PHQ-9
Zeitfenster: 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.
6 weeks and 10 to 12 weeks post-randomization
Number of treatment sessions received
Zeitfenster: 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.
From treatment initiation through completion of the active treatment period, approximately 4 weeks
Treatment and study dropout rate
Zeitfenster: 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.
Through 10 to 12 weeks post-randomization
Protocol deviation rate
Zeitfenster: Through 10 to 12 weeks post-randomization
The number and proportion of participants with documented protocol deviations will be summarized by treatment arm.
Through 10 to 12 weeks post-randomization

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Painhunting mechanism recognition across treatment sessions
Zeitfenster: 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.
Across Painhunting treatment sessions, approximately 2 to 4 weeks
Therapeutic alliance measured by the Working Alliance Inventory - Short Form
Zeitfenster: 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.
Session 2 and Session 4 (Week 1 and Week 2)
Per-session trajectory of depressive symptoms measured by PHQ-9
Zeitfenster: 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.
1 to 2 days after each treatment session during the active treatment period (Week 1-3)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Painhunting LLP

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

28. Februar 2027

Studienabschluss (Geschätzt)

30. April 2027

Studienanmeldedaten

Zuerst eingereicht

23. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

31. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-2167

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the results reported in the primary publication, together with analysis scripts, will be made publicly available on the Open Science Framework (OSF).

IPD-Sharing-Zeitrahmen

Data and supporting materials will become available concurrent with publication of the primary study results and will remain available indefinitely.

IPD-Sharing-Zugriffskriterien

De-identified data and supporting materials will be publicly available through the Open Science Framework (OSF).

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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