UMIN ID: UMIN000054190
Registered date:18/04/2024
Effectiveness of Cognitive Behavioral Group Therapy Based on a Viewpoint of Zen Buddhism for Somatic Symptom and Related Disorders - An Exploration Applying Virtual Reality -
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Somatic Symptom and Related Disorders |
| Date of first enrollment | 2024/05/19 |
| Target sample size | 108 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cognitive Behavioral Group Therapy with VR-based Zen Treatment as usual or waiting list |
Outcome(s)
| Primary Outcome | PHQ 15 (Patient Health Questionnaire 15), SSD 12 (The Somatic Symptom Disorder, B Criteria Scale) |
|---|---|
| Secondary Outcome | PHQ-9 (Patient Health Questionnaire-9), GAD-7 (Generalized Anxiety Disorder-7), VAS (Visual analog Scale), PCS (Pain Catastrophe Scale), EQ-5D-5L, SHAI (Short Health Anxiety Inventory), SIUS (The Short Intolerance of Uncertainty Scale) and others |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Those who have insufficient ability to speak and understand Japanese. (2)Persons undergoing other professional psychotherapy or clinical trials (3)Other patients who are deemed inappropriate by the doctor in charge. |
Related Information
| Primary Sponsor | Kyoto Prefectural University of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology (MEXT) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshiyuki Tominaga |
| Address | 465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku, Kyoto Japan Japan 6168186 |
| Telephone | 0752515612 |
| totomi@koto.kpu-m.ac.jp | |
| Affiliation | Kyoto Prefectural University of Medicine Department of Psychiatry, Graduate School of Medical Science |
| scientific contact | |
| Name | Toshiyuki Tominaga |
| Address | 465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku, Kyoto Japan Japan |
| Telephone | 0752515612 |
| totomi@koto.kpu-m.ac.jp | |
| Affiliation | Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Psychiatry, Graduate School of Medical Science |