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Recruiting NCT07105345

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

No phase Interventional Posttraumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Processing Therapy (CPT), Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Cognitive Processing Therapy (CPT)
    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.
  • Other Treatment as Usual (TAU)
    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.

Primary outcome measures

  • Change in PTSD symptom severity (CAPS-5) [Time frame: Baseline (Screening Visit, prior to randomization)]
Secondary outcome measures (5)
  • Change in PTSD symptoms (PCL-5) [Time frame: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up]
  • Sleep quality (PSQI score and actigraphy) [Time frame: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up]
  • Anxiety symptoms (STAI) [Time frame: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up]
  • Depression symptoms (HDRS-17) [Time frame: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up]
  • Posttraumatic growth (PTGI) [Time frame: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • Far Eastern Memorial Hospital — New Taipei City
  • Far Eastern Memorial Hospital — New Taipei City

Identifiers

NCT: NCT07105345 · FEMH No.：114037-F · IRB FEMH No.：114037-F

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗