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

NCT07105345 | Recruiting

• 2 other identifiers: FEMH No.：114037-FIRB FEMH No.：114037-F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Cognitive Processing Therapy; Trauma-focused therapy; Sleep quality; Anxiety; RCT; Taiwan; Depression

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• 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

• 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

• Anxiety symptoms (STAI)

  Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up

• Depression symptoms (HDRS-17)

  Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up

• Posttraumatic growth (PTGI)

  Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up

Study Arms (2)

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.

Behavioral: Cognitive Processing Therapy (CPT)

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.

Other: Treatment as Usual (TAU)

Interventions

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.

Also known as: MMCPT

Cognitive Processing Therapy (CPT)

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.

Also known as: Standard psychiatric care

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (2)

Far Eastern Memorial Hospital

New Taipei City, Banqiao District, 220, Taiwan

NOT YET RECRUITING

Far Eastern Memorial Hospital

New Taipei City, Banqiao District, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Hsin-I Liu, PhD, RN

CONTACT

+886-2-8966-7000; femh91095@femh.org.tw

Pei-Chuan Wu, MD

CONTACT

+886-2-8966-7000; femh91988@femh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group assignment to reduce bias in post-intervention evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomized controlled trial with participants assigned to either CPT or TAU.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: August 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)