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

NCT07624708 | Completed

• 1 other identifier: UCP/PSY/PUB/0063
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Posttraumatic Stress Disorder

Keywords

PTSD; Psychological Inflexibility; Emotional Dysregulation; Acceptance and Commitment Therapy (ACT),; web based mental health application

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

TREATMENT AS USUAL

EXPERIMENTAL

Patients received Acceptance Commitment Therapy in clinical setting. This phase was the treatment phase of the study.

Behavioral: Acceptance Commitment Therapy

Face-to-face ACT with app support

EXPERIMENTAL

Received ACT intervention through face-to-face sessions along with web-based app assistance.

Behavioral: Acceptance Commitment Therapy

Online ACT with app support

EXPERIMENTAL

Online ACT intervention along with web-based app assitance.

Behavioral: Acceptance Commitment Therapy

Interventions

Acceptance Commitment Therapy BEHAVIORAL

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.

Face-to-face ACT with app support; Online ACT with app support; TREATMENT AS USUAL

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically diagnosed individual having PTSD.
• Individuals having a minimum education level of graduation degree
• Individuals who can provide informed consent.

You may not qualify if:

• Individuals with primary diagnoses other than PTSD.
• Individuals with a neurological history.
• Individuals having brain damage by birth or due to any traumatic injury

Sponsors & Collaborators

• University of Central Punjab: lead

Study Sites (1)

Lubna DAR

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lubna DAR

  University of Central Punjab

  PRINCIPAL INVESTIGATOR

• SHAZIA HASAN

  University of Central Punjab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 3, 2026
• Study Start: September 4, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 10, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)