Software as a Medical Device for the treatment of patients with PTSD

JRCT ID: jRCT2032240310

Registered date:02/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Post-Traumatic Stress Disorder (PTSD)
• Date of first enrollment: 01/09/2024
• Target sample size: 52
• Study type: Interventional
• Intervention(s): Software as a Medical Device

Outcome(s)

• Primary Outcome: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

Diagnosis of PTSD according to the DSM-5
Subjects who are within 1 to 20 years since index trauma

Exclude criteria

1. Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5.
2. Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5 that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator
3. Subjects who have completed two or more full courses of trauma-focused therapy in the past

Related Information

• Primary Sponsor: Oe Misari
• Secondary ID(s): Nil known