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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Cognitive Processing Therapy (CPT)
BehavioralParticipants 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Anxiety symptoms (STAI)
Anxiety severity will be measured using the State-Trait Anxiety Inventory (STAI). Each subscale score ranges from 20 to 80.
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.
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.
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