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

2026年7月28日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • カザフスタン
    • Astana
      • Astana、Astana、カザフスタン、010000
        • Central Painhunting Office
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
アクティブコンパレータ：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Painhunting mechanism recognition across treatment sessions
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Painhunting LLP

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年2月28日

研究の完了 (推定)

2027年4月30日

試験登録日

最初に提出

2026年7月23日

QC基準を満たした最初の提出物

2026年7月28日

最初の投稿 (実際)

2026年7月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月31日

QC基準を満たした最後の更新が送信されました

2026年7月28日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB-2167

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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