Three-Arm Quasi-Experimental Study of App-Assisted Acceptance and Commitment Therapy for Post-Traumatic Stress Symptoms
2026年6月1日 更新者：Lubna DAR、University of Central Punjab
A Three-Arm Quasi-Experimental Study Comparing Treatment-as-Usual, Face-to-Face Acceptance and Commitment Therapy With App-Assisted Support, and Online Acceptance and Commitment Therapy With App-Assisted Support for PTSD Symptoms
The goal of this clinical trial is to compare the efficacy of three Acceptance and Commitment Therapy (ACT) delivery modalities in treating Post-Traumatic Stress Disorder (PTSD) in adult patients (ages 20-40) with mild to moderate PTSD severity in Pakistan.
The main questions it aims to answer are:
- Do participants show significant reductions in psychological inflexibility, emotional dysregulation, and PTSD symptom severity from pre- to post-intervention?
- Which ACT delivery modality - treatment as usual (TAU/clinic-only), clinician-guided with web-app assistance, or online-only with web-app assistance - produces the greatest improvements in these outcomes?
Researchers will compare three groups: (A) TAU receiving clinic-based ACT sessions without app support, (B) clinic-based ACT sessions assisted by the "ACT PTSD" web application, and (C) fully online ACT delivery with web-app support - to determine whether digital augmentation enhances treatment outcomes beyond standard clinical delivery.
Participants will:
- Complete baseline assessments (PCL-5, AAQ-II, DERS-SF, PDEQ-SF) at intake
- Attend 12 weekly individual ACT sessions (30-45 minutes each) covering psychoeducation, acceptance, cognitive defusion, self-as-context, grounding, values clarification, committed action, trauma processing, and relapse prevention
- Use the "ACT PTSD" web application between sessions (Groups B and C), which delivers the six ACT core processes through guided exercises, audio tracks, symptom tracking, and therapist messaging
- Complete post-intervention assessments and one follow-up session after the 12-week program
調査の概要
研究の種類
介入
入学 (実際)
30
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。
研究場所
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Punjab Province
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Lahore、Punjab Province、パキスタン、54000
- Lubna DAR
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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
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Clinically diagnosed individual having PTSD.
- Individuals having a minimum education level of graduation degree
- Individuals who can provide informed consent.
Exclusion Criteria:
- Individuals with primary diagnoses other than PTSD.
- Individuals with a neurological history.
- Individuals having brain damage by birth or due to any traumatic injury
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TREATMENT AS USUAL
Patients received Acceptance Commitment Therapy in clinical setting.
This phase was the treatment phase of the study.
|
The ACT Path web application is a clinician-gated, ACT-based treatment-assistance tool developed specifically for adults with PTSD.
Unlike self-administered apps, it operates within a therapist-controlled workflow: clients access 12 structured weekly sessions only after clinical approval, with session assignment (including flexible sequencing of trauma narrative work) guided by the therapist.
All six ACT hexaflex processes are delivered via interactive sessions with embedded audio guidance and gamified defusion exercises.
Built-in validated assessments (PCL-5, AAQ-II, DERS-SF, PDEQ-SF) auto-score and populate a therapist dashboard; a unique safety screen flags suicidal ideation and harm risk across three timeframes.
A panic button provides crisis support.
Cultural adaptation for a collectivistic, low-resource context distinguishes it from existing Western-developed PTSD apps.
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実験的：Face-to-face ACT with app support
Received ACT intervention through face-to-face sessions along with web-based app assistance.
|
The ACT Path web application is a clinician-gated, ACT-based treatment-assistance tool developed specifically for adults with PTSD.
Unlike self-administered apps, it operates within a therapist-controlled workflow: clients access 12 structured weekly sessions only after clinical approval, with session assignment (including flexible sequencing of trauma narrative work) guided by the therapist.
All six ACT hexaflex processes are delivered via interactive sessions with embedded audio guidance and gamified defusion exercises.
Built-in validated assessments (PCL-5, AAQ-II, DERS-SF, PDEQ-SF) auto-score and populate a therapist dashboard; a unique safety screen flags suicidal ideation and harm risk across three timeframes.
A panic button provides crisis support.
Cultural adaptation for a collectivistic, low-resource context distinguishes it from existing Western-developed PTSD apps.
|
|
実験的：Online ACT with app support
Online ACT intervention along with web-based app assitance.
|
The ACT Path web application is a clinician-gated, ACT-based treatment-assistance tool developed specifically for adults with PTSD.
Unlike self-administered apps, it operates within a therapist-controlled workflow: clients access 12 structured weekly sessions only after clinical approval, with session assignment (including flexible sequencing of trauma narrative work) guided by the therapist.
All six ACT hexaflex processes are delivered via interactive sessions with embedded audio guidance and gamified defusion exercises.
Built-in validated assessments (PCL-5, AAQ-II, DERS-SF, PDEQ-SF) auto-score and populate a therapist dashboard; a unique safety screen flags suicidal ideation and harm risk across three timeframes.
A panic button provides crisis support.
Cultural adaptation for a collectivistic, low-resource context distinguishes it from existing Western-developed PTSD apps.
|
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 |
|---|---|---|
|
PCL-5
時間枠：pre-intervention and immediatly after the intervention
|
PCL-5 is a 20-item self-report measure designed to evaluate the severity of PTSD symptoms.
The scale uses a 5-point Likert scale from 0-4 (0= Not at all & 4=Extremely).
The scores range from 0 to 80.
The scales showed good internal reliability with a Cronbach's Alpha value of 0.90.
The scale has no reverse-coded items.
The scale has 4 subscales: Cluster B: Intrusion symptoms (5 items), Cluster C: Avoidance (2 items), Cluster D: Negative alterations in cognitions and mood (7 items), and Cluster E: Alterations in arousal and reactivity (6 items)
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pre-intervention and immediatly after the intervention
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Acceptance and Action Questionnaire-II (AAQ-II)
時間枠：pre-intervention and immediatly after the intervention
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Psychological inflexibility was measured with the Acceptance and Action Questionnaire-II (AAQ-II), which is a brief 7-item self-report measure.
AAQ-II uses a 7-point Likert scale ranging from 1 (never true) to 7 (always true).
The scale is also a unidimensional scale with no reverse coding.
Low scores indicate the presence of psychological flexibility, whereas higher scores indicate higher psychological inflexibility.
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pre-intervention and immediatly after the intervention
|
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Difficulty in Emotion Regulation Scale Short Form (DERS-SF)
時間枠：pre-intervention and immediatly after the intervention
|
The DERS-SF is an 18-item self-report measure designed to evaluate individuals' typical patterns of emotional regulation difficulties while maintaining the score structure of the original DERS.
The scale utilizes a 5-point Likert scale (1=Almost never to 5=Almost always).
The total score ranges from 18 to 90; a higher score indicates higher emotional dysregulation.
The scale also showed good internal reliability, 0.89-0.94.
The scale has 6 subscales: Non-acceptance of emotional responses (3 items), difficulty engaging in goal-directed behavior (3 items), impulse control difficulties (3 items), lack of emotional awareness (3 items), limited access to emotion regulation strategies (3 items), and lack of emotional clarity (3 items).
All the items of lack of emotional awareness are reverse-coded items.
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pre-intervention and immediatly after the intervention
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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。
捜査官
- 主任研究者：Lubna DAR、University of Central Punjab
- 主任研究者：SHAZIA HASAN、University of Central Punjab
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 (実際)
2025年9月4日
一次修了 (実際)
2026年4月30日
研究の完了 (実際)
2026年5月10日
試験登録日
最初に提出
2026年5月25日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6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
- UCP/PSY/PUB/0063
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?
いいえ
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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
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