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| ID | Type | Description | Link |
|---|---|---|---|
| IRB FEMH No.：114037-F | Other Identifier | Far Eastern Memorial Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Participants in this arm will receive 12 weekly individual sessions of Cognitive Processing Therapy (CPT), based on the Resick protocol. Each session will last 90 minutes and will be delivered by a trained therapist. The therapy integrates cognitive restructuring, trauma-related belief processing, and behavioral assignments. |
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| Treatment as Usual (TAU) | Active Comparator | Participants in this group will receive routine outpatient psychiatric care as determined by their clinician, which may include medication, general supportive therapy, or psychoeducation, but will not include structured CPT sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy (CPT) | Behavioral | Participants will receive 12 weekly 90-minute individual sessions of Cognitive Processing Therapy (CPT) following the Resick manual. The intervention includes cognitive restructuring, trauma-related belief processing, and structured behavioral assignments. Sessions are delivered by trained therapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptom severity (CAPS-5) | 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. | Baseline (Screening Visit, prior to randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms (PCL-5) | 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. | Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsin-I Liu, PhD, RN | Contact | +886-2-8966-7000 | 4941 | femh91095@femh.org.tw |
| Pei-Chuan Wu, MD | Contact | +886-2-8966-7000 | femh91988@femh.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | Not yet recruiting | New Taipei City | Banqiao District | 220 | Taiwan |
Due to privacy and ethical considerations, no plan to share individual participant data (IPD) has been determined at this time. If data sharing is considered in the future, it will follow IRB approval and data use request procedures.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Two-arm randomized controlled trial with participants assigned to either CPT or TAU.
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Outcome assessors will be blinded to group assignment to reduce bias in post-intervention evaluations.
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| Treatment as Usual (TAU) | Other | Participants will receive routine outpatient psychiatric care as determined by clinicians. This may include medication, general supportive therapy, or psychoeducation, but will not include structured CPT sessions. |
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| Sleep quality (PSQI score and actigraphy) |
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and actigraphy monitoring. The PSQI score ranges from 0 to 21. |
| Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up |
| Anxiety symptoms (STAI) | Anxiety severity will be measured using the State-Trait Anxiety Inventory (STAI). Each subscale score ranges from 20 to 80. | Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up |
| Depression symptoms (HDRS-17) | 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. | Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up |
| Posttraumatic growth (PTGI) | 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. | Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up |
| Far Eastern Memorial Hospital | Recruiting | New Taipei City | Banqiao District | 220 | Taiwan |
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |