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

NCT ID: NCT07105345

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-04-30

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.

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Processing Therapy (CPT)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

MMCPT; Standard psychiatric care

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Far Eastern Memorial Hospital

New Taipei City, Banqiao District, Taiwan

Countries

Taiwan

Central Contacts

Hsin-I Liu, PhD, RN

Role: CONTACT

femh91095@femh.org.tw

+886-2-8966-7000 ext. 4941

Pei-Chuan Wu, MD

Role: CONTACT

femh91988@femh.org.tw

+886-2-8966-7000

Facility Contacts

Hsin-I Liu, PhD, RN

Role: primary

mimiko0523@gmail.com

+886-2-8966-7000 ext. 4941

Other Identifiers

IRB FEMH No.：114037-F

Identifier Type: OTHER

Identifier Source: secondary_id

FEMH No.：114037-F

Identifier Type: -

Identifier Source: org_study_id