Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058527) titled 'A randomized controlled trial to verify the effectiveness of community-based Prolonged Exposure for victims of sexual violence' on July 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Musashino University
Condition:
Condition - Posttraumatic Stress Disorder (PTSD)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effectiveness of the implementation of online PE in each remote location
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Online PE for sexual assault victims with PTSD
Interventions/Control_2 - Treatment-as-usual only
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. The subject is consulting at the community rape crisis center, and the rape crisis center staff has agreed to cooperate with this study.
2. Diagnosed with PTSD by the community psychiatric medical institution.
3. The psychiatrist has approved the subject's participation in this study, and continuation of their once or if necessary, more than once a month consultation throughout the period of the study.
4. During the course of the PE, the subject and psychiatrist have agreed that the therapist, assessor, rape crisis center staff, etc., may inquiry them regarding the treatment, prescription, etc. of the subject.
5. Using CAPS-5, the subject has been assessed with PTSD or a condition equivalent to PTSD (adjustment disorder, etc.) in relation to the identified traumatic experience.
6. The subjects is able to visit the community rape crisis center once a week.
7. The subject is able to use an online device and communicate in Japanese adequately.
Key exclusion criteria - 1. The subject has comorbid diagnosis of schizophrenia and other related disorders.
2. The subject has comorbid physical disorder in which would interfere with the treatment.
3. There is a presence of psychological symptoms (manic state of bipolar disorder and extreme emotional instability, alcohol/substance abuse/dependence, severe depressive symptoms, self-harming behaviors, suicidal attempts, etc.) for which other immediate treatment/s should be prioritized.
4. The subject has clinical history of alcohol/substance dependence or abuse within the past 6 months.
5. The subject has clinical history of suicidal attempt and serious self-harming behaviors (manipulative self-harm such as severe cut wounds, unconsciousness or overdose, etc.) within the past 6 months.
6. The subject has changes in the prescription of antidepressants and antipsychotic medications for the past month, and currently has plans in changing the prescription during the course of the treatment.
7. The subject is currently receiving any specific psychotherapeutic treatment/s other than supportive psychotherapy.
8. If the researcher determines that the subject is inappropriate
Target Size - 34
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 06 Month 05 Day
Date of IRB - 2025 Year 06 Month 26 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066927
Disclaimer: Curated by HT Syndication.
