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NCT Number: NCT07105345

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Memorial Hospital

New Taipei City, Banqiao District, 220, Taiwan

Location status: Recruiting

Location contact

Hsin-I Liu, PhD, RN

CONTACT

[email protected]

+886-2-8966-7000 ext. 4941

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: MMCPT

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.

Other names: Standard psychiatric care

Primary outcomes

  1. Change in PTSD symptom severity (CAPS-5)

    Time frame: Baseline (Screening Visit, prior to randomization)

    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.

  2. 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

    Self-reported PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5). The score ranges from 0 to 80; higher scores indicate more severe symptoms.

Secondary outcomes

  1. 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

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) . The PSQI score ranges from 0 to 21.

  2. 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

    Anxiety severity will be measured using the State-Trait Anxiety Inventory (STAI). Each subscale score ranges from 20 to 80.

  3. 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

    Depression severity will be assessed using the 17-item Hamilton Depression Rating Scale (HDRS-17). The total score ranges from 0 to 52, with higher scores indicating more severe depression symptoms.

  4. 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

    Posttraumatic growth will be assessed using the Posttraumatic Growth Inventory (PTGI). The total score ranges from 0 to 105, with higher scores indicating greater posttraumatic growth.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsin-I Liu, PhD, RN

CONTACT

[email protected]

+886-2-8966-7000 ext. 4941

Pei-Chuan Wu, MD

CONTACT

[email protected]

+886-2-8966-7000

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study 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

Acronym: PTSD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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