Posttraumatic Stress DisorderPTSDNCT07105345
Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD
A study testing Cognitive Processing Therapy (CPT) and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy (CPT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, Banqiao District, 220
Hsin-I Liu, PhD, RN, +886-2-8966-7000 ext. 4941, mimiko0523@gmail.com
About this study
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
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.
Read the 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
- Being tested
- Cognitive Processing Therapy (CPT), Treatment as Usual (TAU)
- Keywords
- Cognitive Processing Therapy, Trauma-focused therapy, Sleep quality, Anxiety, RCT, Taiwan, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy (CPT)Behavioural
Also called MMCPT
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)Other
Also called Standard psychiatric care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Screening Visit, prior to randomization)
Change in PTSD symptoms (PCL-5)
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.
Measured: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
Secondary outcomes (4)
Sleep quality (PSQI score and actigraphy)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) . The PSQI score ranges from 0 to 21.
Measured: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
Anxiety symptoms (STAI)
Anxiety severity will be measured using the State-Trait Anxiety Inventory (STAI). Each subscale score ranges from 20 to 80.
Measured: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
Depression symptoms (HDRS-17)
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.
Measured: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
Posttraumatic growth (PTGI)
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.
Measured: Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial with participants assigned to either CPT or TAU.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105345
- Sponsor's protocol ID
- FEMH No.：114037-F
- Other IDs
- IRB FEMH No.：114037-F
- Acronym
- PTSD
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy and ethical considerations, no plan to share individual participant data (IPD) has been determined at this time. If data sharing is considered in the future, it will follow IRB approval and data use request procedures.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07105345
- Acronym / sponsor ID
- PTSD / FEMH No.：114037-F
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Cognitive Processing Therapy, Trauma-focused therapy, Sleep quality, Anxiety, RCT, Taiwan, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial with participants assigned to either CPT or TAU.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Behavioral: 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. |
| Treatment as Usual (TAU) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing Therapy (CPT)Also: MMCPTParticipants 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. | Behavioural | Cognitive Processing Therapy (CPT) |
| Treatment as Usual (TAU)Also: Standard psychiatric careParticipants 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 | Treatment as Usual (TAU) |
Primary outcome
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. Due to privacy and ethical considerations, no plan to share individual participant data (IPD) has been determined at this time. If data sharing is considered in the future, it will follow IRB approval and data use request procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy (CPT) and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsin-I Liu, PhD, RN (+886-2-8966-7000 ext. 4941, femh91095@femh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptom severity (CAPS-5) (time frame: Baseline (Screening Visit, prior to randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.