Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059979) titled 'Effect of Brief Sleep Cognitive Behavioral Therapy on Preventing Depression in Postpartum Couples: A Randomized Controlled Trial' on Dec. 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kitasato University

Condition: Condition - Healthy pregnant women and their husbands or partners Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - 1. To develop a brief cognitive behavioral therapy for insomnia program (brief CBT-I program) for couples from pregnancy through the postpartum period. 2. To evaluate the effectiveness of the developed brief CBT-I program in reducing postpartum depression among postpartum couples through a randomized controlled trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - At 8 months of pregnancy (first intervention), participants will be asked to watch a video-based brief CBT-I program consisting of sleep hygiene education, sleep restriction therapy, stimulus control therapy, and relaxation techniques. The program also includes content on physiological changes during pregnancy, sleep alterations in pregnant women, sex differences in sleep, and lifestyle changes. Interventions/Control_2 - At 1 month postpartum (second intervention), participants will be asked to watch a video-based brief CBT-I program consisting of sleep hygiene education, sleep restriction therapy, stimulus control therapy, and relaxation techniques. In addition to reviewing the content from the first prenatal session, the program also includes information on understanding newborn nighttime awakenings, as well as postpartum daily life and strategies for securing adequate sleep.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Couples who participate in municipal maternal-child health services or visit a hospital/clinic between October 1, 2025, and June 30, 2026. 2. Couples in which both partners are 18 years or older. 3. Couples in which the pregnant partner is between 4 and 8 months of gestation. 4. Couples with an expected delivery date between April 2, 2026, and August 5, 2026. 5. Couples who have concerns or interests regarding sleep. 6. Couples who receive an explanation of the study and provide informed consent to participate. Note: Couples are defined as a man and a woman who will share childbirth and child-rearing, regardless of legal marital status. Key exclusion criteria - 1. Couples in which either partner is currently receiving psychiatric or psychosomatic medical care. 2. Couples with a multiple pregnancy. 3. Couples in which only one partner can participate in the study. Target Size - 400

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 30 Day Date of IRB - 2025 Year 12 Month 04 Day Anticipated trial start date - 2025 Year 12 Month 18 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068508

Disclaimer: Curated by HT Syndication.