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

NCT07624708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-03

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Central Punjab

    lead OTHER

Principal Investigators

  • Lubna DAR · University of Central Punjab

  • SHAZIA HASAN · University of Central Punjab

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2026-04-30
Completion
2026-05-10

Countries

  • Pakistan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624708 on ClinicalTrials.gov