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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorFar Eastern Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Treatment as Usual (TAU)

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cognitive Processing Therapy (CPT)Experimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Active comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline (Screening Visit, prior to randomization)
2

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.

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

Secondary outcomes

1

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.

Time frame
Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
2

Anxiety symptoms (STAI)

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

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

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.

Time frame
Baseline, Week 6 ( Mid-treatment), Week 12 (Post-treatment), Month 3, Month 6, Month 9, and Month 12 follow-up
4

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.

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

Other outcomes

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