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Three-Arm Quasi-Experimental Study of App-Assisted Acceptance and Commitment Therapy for Post-Traumatic Stress Symptoms

1 juin 2026 mis à jour par: 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:

  1. Do participants show significant reductions in psychological inflexibility, emotional dysregulation, and PTSD symptom severity from pre- to post-intervention?
  2. 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Lubna DAR

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: TREATMENT AS USUAL
Patients received Acceptance Commitment Therapy in clinical setting. This phase was the treatment phase of the study.
Comportemental: Acceptance Commitment Therapy
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.
Expérimental: Face-to-face ACT with app support
Received ACT intervention through face-to-face sessions along with web-based app assistance.
Comportemental: Acceptance Commitment Therapy
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.
Expérimental: Online ACT with app support
Online ACT intervention along with web-based app assitance.
Comportemental: Acceptance Commitment Therapy
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PCL-5
Délai: 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)
pre-intervention and immediatly after the intervention
Acceptance and Action Questionnaire-II (AAQ-II)
Délai: pre-intervention and immediatly after the intervention
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.
pre-intervention and immediatly after the intervention
Difficulty in Emotion Regulation Scale Short Form (DERS-SF)
Délai: 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.
pre-intervention and immediatly after the intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Central Punjab

Les enquêteurs

  • Chercheur principal: Lubna DAR, University of Central Punjab
  • Chercheur principal: SHAZIA HASAN, University of Central Punjab

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 septembre 2025

Achèvement primaire (Réel)

30 avril 2026

Achèvement de l'étude (Réel)

10 mai 2026

Dates d'inscription aux études

Première soumission

25 mai 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UCP/PSY/PUB/0063

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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