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

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

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Acceptance Commitment Therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TREATMENT AS USUAL; Patients received Acceptance Commitment Therapy in clinical setting. This phase was the treatment phase of the study.	Behavioral: 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.	Behavioral: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCL-5	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)	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)	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

Collaborators and Investigators

• Sponsor: University of Central Punjab
• Investigators: Principal Investigator: Lubna DAR, University of Central Punjab; Principal Investigator: SHAZIA HASAN, University of Central Punjab

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): May 10, 2026

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Emotional Dysregulation; Psychological Inflexibility; Acceptance and Commitment Therapy (ACT),; web based mental health application
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: UCP/PSY/PUB/0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No