Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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Efficacy of Multi-Modal Cognitive Processing Therapy for PTSD: A Longitudinal, Multicenter, Single-Blind RCT on Symptoms, Sleep, Anxiety, Depression, Remission, and Posttraumatic Growth

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Far Eastern Memorial Hospital
NOT_YET_RECRUITING
New Taipei City
Contact Information
Primary
Hsin-I Liu, PhD, RN
femh91095@femh.org.tw
+886-2-8966-7000
Backup
Pei-Chuan Wu, MD
femh91988@femh.org.tw
+886-2-8966-7000
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Cognitive Processing Therapy (CPT)
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.
Active_comparator: Treatment as Usual (TAU)
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.
Related Therapeutic Areas
Sponsors
Leads: Far Eastern Memorial Hospital

This content was sourced from clinicaltrials.gov

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