Three-Arm Quasi-Experimental Study of App-Assisted Acceptance and Commitment Therapy for Post-Traumatic Stress Symptoms
2026년 6월 1일 업데이트: 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
연구 개요
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Punjab Province
-
Lahore, Punjab Province, 파키스탄, 54000
- Lubna DAR
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
실험적: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PCL-5
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Lubna DAR, University of Central Punjab
- 수석 연구원: SHAZIA HASAN, University of Central Punjab
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 9월 4일
기본 완료 (실제)
2026년 4월 30일
연구 완료 (실제)
2026년 5월 10일
연구 등록 날짜
최초 제출
2026년 5월 25일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- UCP/PSY/PUB/0063
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .