Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062966) titled 'A Study on the Efficacy of TF-CBT for Trauma-Related Disorders Caused by Disasters and Other Traumatic Events, Using Brain Imaging' on Sept. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Trauma-related disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study to examine whether the therapeutic effects of TF-CBT are reflected in biological changes in the brain.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - TF-CBT is a proven psychotherapy that involves 8 to 18 weekly 80- to 90-minute sessions with a practitioner (hereinafter referred to as the therapist). The program consists of child sessions, parent sessions, and joint parent-child sessions; however, until the middle of the program, sessions are conducted separately for parents and children (child sessions and parent sessions), and toward the end, the child and parent come together in joint sessions to share what they have learned and the outcomes achieved through the program. The frequency of sessions is adjusted flexibly to suit each individual case.
Interventions/Control_2 - Patients are placed on a waiting list for TF-CBT and, while receiving standard treatment such as supportive psychotherapy, await their turn to be transferred to the treatment group.
Eligibility:
Age-lower limit - 6
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Has been diagnosed with PTSD or a trauma-related disorder.
2. Have a parent or other caretaker who is available in treatment sessions.
3. Fixed medication regimen for at least 4 weeks prior to the treatment.
Key exclusion criteria - 1. Comorbidity of active psychotic symptoms and/or substance abuse.
2. Presence of severe depressive symptoms and/or serious suicidal risk.
3. Presence of oppositional attitude, severe aggression and/or antisocial behaviors.
4. parent of a caretaker who will participant in treatment has 1,2or3.
Target Size - 46
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2016 Year 03 Month 20 Day
Date of IRB - 2016 Year 05 Month 28 Day
Anticipated trial start date - 2016 Year 06 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072074
Disclaimer: Curated by HT Syndication.