NCT03652298

✓ Unanimous Initial: yes Requery: no — The intervention involves a neuroscience-based Memory Structuring Intervention combined with vagal breathing techniques, which are psychological interventions rather than traditional CAM modalities like acupuncture, massage, or herbal remedies.

✓ Unanimous Initial: no Requery: no — The trial focuses on Memory Structuring Intervention and vagal breathing, which are not classified as complementary modalities such as acupuncture, aromatherapy, or massage.

✓ Unanimous Initial: no Requery: no — The intervention is a neuroscience-based psychological technique (Memory Structuring Intervention and vagal breathing) for PTSD symptom management, not a complementary and alternative medicine (CAM) modality.

✓ Unanimous Initial: yes Requery: yes — The intervention combines two distinct components from different categories - Memory Structuring Intervention (MSI) which is a psychological/cognitive intervention and vagal breathing (VB) which is a physiological/breathing technique, working together as an integrated neuroscience-based approach.

✓ Unanimous Initial: yes Requery: yes — The study combines psychological components (Memory Structuring Intervention) with physiological components (vagal breathing) to create a multi-component intervention aimed at PTSD treatment.

✓ Unanimous Initial: no Requery: yes — The intervention explicitly combines two distinct interacting components—a psychological/cognitive technique (Memory Structuring Intervention) and a physiological/behavioral breathing technique (Vagal Breathing)—to synergistically shift trauma processing and increase emotional regulation.

✓ Unanimous Initial: no Requery: yes — The primary outcome measures PTSD symptoms using the PCL-5 (PTSD Checklist for DSM-5), which is a validated symptom assessment instrument.

✓ Unanimous Initial: yes Requery: yes — The primary outcome is assessed using the PCL-5, which measures the presence and severity of PTSD symptoms, thus classifying it as a symptom measure.

✓ Unanimous Initial: yes

✓ Unanimous Initial: yes Requery: yes — The study explicitly measures quality-adjusted life years (QALY), which is a health economic outcome that combines survival time with quality of life scores to evaluate cost-effectiveness.

✓ Unanimous Initial: no Requery: yes — The study includes the calculation of quality-adjusted life years (QALY), which is a form of health economic evaluation.

✓ Unanimous Initial: yes Requery: yes — The trial explicitly includes the calculation of Quality-Adjusted Life Years (QALY), which is a standard measure for cost-effectiveness and health economic evaluation.