Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059104) titled 'The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss:A Randomized Controlled Trial' on Sept. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - Recurrent pregnancy loss
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of a newly developed internet-based Compassion Focused Therapy (iCFT) on depressive symptoms in women with recurrent pregnancy loss.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - This study's intervention is a psychiatrist-guided, internet-delivered Compassion-Focused Therapy (iCFT) program. The program consists of four video modules (15-25 minutes each), each covering a different component of CFT: introduction to self-compassion and mindfulness (in module 1), understanding emotional regulation and soothing practices (in module 2), developing compassionate thinking (in module 3), and expressing self-compassion through letter writing (in module 4).
Interventions/Control_2 - Wait list control condition
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - First-time visitor to the study site's RPL outpatient clinic
Have experienced two or more miscarriages or stillbirths (not including abortions)
Married (including common-law marriage)
Have access to the Internet via smartphone, tablet, computer, etc
Have not received any kind of psychotherapy in the past 12 weeks, and has no plans to receive any other psychotherapy during the intervention period
Key exclusion criteria - Pregnant at study entry
Currently undergoing psychosomatic or psychiatric treatment for depression or other mental illness
Having intense suicidal ideation
Target Size - 110
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 11 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 09 Month 18 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=R000067573
Disclaimer: Curated by HT Syndication.
