Using software to help treat PTSD
A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)
This study is testing a new software app to see if it can help people with PTSD feel better after experiencing trauma in the last 1 to 20 years.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Otsuka Medical Devices Co., Ltd. Japan Industry-sponsored |
| Locations | 35 sites (Yamanashi, Hokkaido and 34 other locations) |
| Trial ID | NCT06589505 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a software application designed as a medical device for patients suffering from Post-Traumatic Stress Disorder (PTSD). It targets individuals who have experienced trauma within the last 1 to 20 years and aims to provide a novel therapeutic approach. The study will involve participants diagnosed with PTSD according to DSM-5 criteria, while excluding those with certain other mental health disorders. The intervention will be assessed through a structured methodology to determine its impact on PTSD symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with PTSD who have experienced trauma within the last 1 to 20 years.
Not a fit: Patients with other significant mental health disorders or those who have undergone extensive trauma-focused therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this software could provide a new, effective treatment option for patients with PTSD.
How similar studies have performed: While the use of software as a medical device for mental health treatment is an emerging field, similar approaches have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of PTSD according to the DSM-5 * Subjects who are within 1 to 20 years since index trauma Exclusion Criteria: * Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5. * 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 * Subjects who have completed two or more full courses of trauma-focused therapy in the past
Where this trial is running
Yamanashi, Hokkaido and 34 other locations
- Yamanashi Prefectural Kita Hospital — Yamanashi, Hokkaido, Japan (Recruiting)
- Heart Care Clinic Omachi — Akita, Japan (Recruiting)
- Aburayama Hospital — Fukuoka, Japan (Recruiting)
- Ai Sakura Clinic — Fukuoka, Japan (Recruiting)
- Hatakeyama Clinic — Fukuoka, Japan (Recruiting)
- Hiro Mental Clinic — Fukuoka, Japan (Recruiting)
- Hirota Clinic — Fukuoka, Japan (Recruiting)
- Kurume University Hospital — Fukuoka, Japan (Recruiting)
- Medical corporation Shinseikai Kaku Mental Clinic — Fukuoka, Japan (Recruiting)
- Mental Clinic Sakurazaka — Fukuoka, Japan (Recruiting)
- Nishie Kokorono Clinic — Fukuoka, Japan (Recruiting)
- Uematsu Mental Clinic — Fukuoka, Japan (Recruiting)
- PTSD Care Matsumoto Mental Clinic — Gunma, Japan (Recruiting)
- Goryokai Hospital — Hokkaido, Japan (Recruiting)
- Sakamoto Misako Mental Clinic — Hyōgo, Japan (Recruiting)
- Takahashi Psychiatric Clinic — Hyōgo, Japan (Recruiting)
- Tsukuba Psychosomatics Clinic — Ibaraki, Japan (Recruiting)
- Musashikosugi J Kokorono Clinic — Kanagawa, Japan (Recruiting)
- Niki Hearty Hospital — Kumamoto, Japan (Recruiting)
- Arata Clinic — Nagasaki, Japan (Recruiting)
- Okayama Psychiatric Medical Center — Okayama, Japan (Recruiting)
- Barclay Imuro Mental Clinic — Okinawa, Japan (Recruiting)
- Medical Corporation Mikokorokai Shimizu Clinic — Osaka, Japan (Recruiting)
- Sho Midori Hospital — Saitama, Japan (Recruiting)
- Ai Mental Clinic — Tochigi, Japan (Recruiting)
- i Kokoro Clinic Nihonbashi — Tokyo, Japan (Recruiting)
- Iidabashi Mental Clinic — Tokyo, Japan (Recruiting)
- Ikebukuro Olive Mental Clinic — Tokyo, Japan (Recruiting)
- Kitaikebukuro Kokoro No Clinic — Tokyo, Japan (Recruiting)
- Maynds Tower Mental Clinic — Tokyo, Japan (Recruiting)
- Monzennakacho Mental Clinic — Tokyo, Japan (Recruiting)
- Nippon Medical School Hospital — Tokyo, Japan (Recruiting)
- Sakurazaka Clinic SophyAnce — Tokyo, Japan (Recruiting)
- Sangenjaya Nakamura Mental Clinic — Tokyo, Japan (Recruiting)
- Wakamatsucho Kokoro to Hifu Clinic — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Kentaro Ishinabe
- Email: OtsukaRegistry-CT@otsuka.jp
- Phone: +81-3-6361-7459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.