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

Study acronym: PTSD
StatusRecruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
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Record History

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  1. Notable Primary endpoint(s) modified
    • Study sites: 2 to 1
    • Secondary endpoints: 5 to 4
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Enrollment target: 30 to 60
    • Primary completion date: Jun 30, 2026 to Jun 30, 2027
    • Study sites: 1 to 2
    • Study completion date: Apr 30, 2027 to Dec 31, 2027
  3. Notable Start date: Jul 30, 2025 to Sep 1, 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07105345
Lead Sponsor Far Eastern Memorial Hospital
Conditions
(from sponsor)
Posttraumatic Stress Disorder
Related terms Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov