Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061209) titled 'Preventing Perinatal Depression in Expectant Couples: A Randomized Controlled Trial of One-Day CBT Workshops via In-person and Online Delivery' on April 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - NA
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study investigates the preventive effects of a "One-Day Cognitive Behavioral Therapy (CBT)" on perinatal depression among expectant couples using a randomized controlled trial. The program is designed for both in-person and online delivery. Beyond evaluating the efficacy of these two formats, the study seeks to clarify their respective strengths and limitations, as well as to develop strategic improvements for their practical application.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - One-Day CBT in person
Interventions/Control_2 - Online One-Day CBT
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Depressive symptoms in the pregnant woman are subthreshold (Patient Health Questionnaire-9 [PHQ-9] score <9).
(2) Depressive symptoms in the partner/father are subthreshold (PHQ-9 score <9).
(3) The pregnant woman is aged between 20 and 49 years (no age requirement for the partner).
(4) The pregnant woman is between 20 and 36 weeks of gestation.
(5) Proficiency in understanding, reading, and writing Japanese.
Key exclusion criteria - (1) Either the woman or her partner is currently receiving psychiatric or psychosomatic medical treatment.
(2) High-risk pregnancy, including but not limited to threatened miscarriage, threatened premature labor, placenta previa, severe pregnancy-induced hypertension, or multiple gestation.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 10 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070037
Disclaimer: Curated by HT Syndication.