Three-Arm Quasi-Experimental Study of App-Assisted Acceptance and Commitment Therapy for Post-Traumatic Stress Symptoms
1 de junio de 2026 actualizado por: 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistán, 54000
- Lubna DAR
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PCL-5
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Lubna DAR, University of Central Punjab
- Investigador principal: SHAZIA HASAN, University of Central Punjab
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de septiembre de 2025
Finalización primaria (Actual)
30 de abril de 2026
Finalización del estudio (Actual)
10 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
25 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UCP/PSY/PUB/0063
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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