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

1. Juni 2026 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

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

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

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: TREATMENT AS USUAL
Patients received Acceptance Commitment Therapy in clinical setting. This phase was the treatment phase of the study.
Verhalten: 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.
Experimental: Face-to-face ACT with app support
Received ACT intervention through face-to-face sessions along with web-based app assistance.
Verhalten: 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.
Experimental: Online ACT with app support
Online ACT intervention along with web-based app assitance.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PCL-5
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

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

Sponsor

University of Central Punjab

Ermittler

  • Hauptermittler: Lubna DAR, University of Central Punjab
  • Hauptermittler: SHAZIA HASAN, University of Central Punjab

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 (Tatsächlich)

4. September 2025

Primärer Abschluss (Tatsächlich)

30. April 2026

Studienabschluss (Tatsächlich)

10. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

25. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UCP/PSY/PUB/0063

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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