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

28 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Kazakistan
    • Astana
      • Astana, Astana, Kazakistan, 010000
        • Central Painhunting Office
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Painhunting mechanism recognition across treatment sessions
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Painhunting LLP

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

28 febbraio 2027

Completamento dello studio (Stimato)

30 aprile 2027

Date di iscrizione allo studio

Primo inviato

23 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 luglio 2026

Primo Inserito (Effettivo)

31 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB-2167

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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).

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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