Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD

Not Applicable

Not yet recruiting

• Conditions: Posttraumatic Stress Disorder

• Registration Number: NCT07105345
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

This study is a longitudinal, multicenter, single-blind, two-arm randomized controlled trial designed to evaluate the effectiveness of Multi-Modal Cognitive Processing Therapy (MMCPT) for individuals with posttraumatic stress disorder (PTSD). Participants will be randomly assigned to either the intervention group receiving MMCPT or a control group receiving treatment-as-usual (TAU). The intervention follows the standard CPT manual developed by Resick and consists of twelve weekly 90-minute individual sessions. The primary outcomes include PTSD symptom severity assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5). Secondary outcomes include sleep quality (actigraphy, PSQI), anxiety (STAI), depression (HDRS-17), remission rate, and posttraumatic growth (PTGI). Assessments will occur at baseline, mid-treatment, post-treatment, and at 3-, 6-, 9-, and 12-month follow-ups.

Detailed Description

This clinical trial aims to construct and evaluate a multi-modal Cognitive Processing Therapy (MMCPT) model and examine its long-term effects on PTSD symptoms, sleep, anxiety, depression, remission, and posttraumatic growth. The study employs a longitudinal, multicenter, single-blind randomized controlled design with two parallel arms. Participants diagnosed with PTSD at psychiatric outpatient clinics will be randomized to either MMCPT or TAU. The MMCPT follows the CPT manual developed by Resick and includes twelve 90-minute weekly individual sessions delivered by fully trained therapists.

The primary outcomes are PTSD symptom severity measured by CAPS-5 and PCL-5. Secondary outcomes include sleep quality measured via actigraphy and the Pittsburgh Sleep Quality Index (PSQI), anxiety levels via the State-Trait Anxiety Inventory (STAI), depression severity via the Hamilton Depression Rating Scale (HDRS-17), remission rate via CAPS-5 and PCL-5, and posttraumatic growth via the Posttraumatic Growth Inventory (PTGI).

Assessments are scheduled at seven time points: pre-treatment, mid-treatment (after session 6), post-treatment (after session 12), and follow-up at 3, 6, 9, and 12 months. The study also includes training and supervision of therapists and evaluators, as well as rigorous monitoring of allocation concealment, treatment fidelity, dropout, medication use, blinding, and adverse events.

Study Timeline

• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Submitted: 2025-08-10
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2026-06-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Aged between 20 and 65 years
• Diagnosed with PTSD according to DSM-5 criteria
• Score ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5)
• Able to provide informed consent
• Stable psychiatric medication regimen (if any) for at least 4 weeks prior to enrollment

Exclusion Criteria

• Diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder
• Current substance dependence or abuse within the past 6 months
• Severe suicidal ideation or suicide attempt in the past 6 months
• Cognitive impairment or neurological disorder affecting participation
• Concurrent participation in other psychological treatment for PTSD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PTSD symptom severity (CAPS-5)	Baseline (Screening Visit, prior to randomization)	PTSD symptom severity will be measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The total score ranges from 0 to 80, with higher scores indicating greater severity.

Secondary Outcome Measures

Name	Time	Method
Change in PTSD symptoms (PCL-5)	Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up	Self-reported PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5). The score ranges from 0 to 80; higher scores indicate more severe symptoms.
Sleep quality (PSQI score and actigraphy)	Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and actigraphy monitoring. The PSQI score ranges from 0 to 21.
Anxiety symptoms (STAI)	Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up	Anxiety severity will be measured using the State-Trait Anxiety Inventory (STAI). Each subscale score ranges from 20 to 80.
Depression symptoms (HDRS-17)	Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up	Depression severity will be assessed using the 17-item Hamilton Depression Rating Scale (HDRS-17). The total score ranges from 0 to 52, with higher scores indicating more severe depression symptoms.
Posttraumatic growth (PTGI)	Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up	Posttraumatic growth will be assessed using the Posttraumatic Growth Inventory (PTGI). The total score ranges from 0 to 105, with higher scores indicating greater posttraumatic growth.

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Banqiao District, Taiwan