Three-Arm Quasi-Experimental Study of App-Assisted Acceptance and Commitment Therapy for Post-Traumatic Stress Symptoms
1 juni 2026 uppdaterad av: 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:
- Do participants show significant reductions in psychological inflexibility, emotional dysregulation, and PTSD symptom severity from pre- to post-intervention?
- 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Lubna DAR
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: TREATMENT AS USUAL
Patients received Acceptance Commitment Therapy in clinical setting.
This phase was the treatment phase of the study.
|
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.
|
|
Experimentell: Face-to-face ACT with app support
Received ACT intervention through face-to-face sessions along with web-based app assistance.
|
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.
|
|
Experimentell: Online ACT with app support
Online ACT intervention along with web-based app assitance.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PCL-5
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Lubna DAR, University of Central Punjab
- Huvudutredare: SHAZIA HASAN, University of Central Punjab
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 september 2025
Primärt slutförande (Faktisk)
30 april 2026
Avslutad studie (Faktisk)
10 maj 2026
Studieregistreringsdatum
Först inskickad
25 maj 2026
Först inskickad som uppfyllde QC-kriterierna
1 juni 2026
Första postat (Faktisk)
3 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UCP/PSY/PUB/0063
Plan för individuella deltagardata (IPD)
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NEJ
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