Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060496) titled 'Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial' on Jan. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Akita University

Condition: Condition - Insomnia Symptoms Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate the effectiveness of digital CBT-based and mindfulness-based interventions among perimenopausal women Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention using a Sleep diary integrated CBTI based application. The sleep coaching program consists of a total of 26 tasks, including cognitive behavioral therapy components such as stimulus control and sleep restriction, stress reduction components such as relaxation, and sleep hygiene components. Participants select three tasks from the presented options and focus on them for four weeks. Each day, they report whether the tasks were implemented and record their sleep status using a sleep diary, including bedtime and wake-up time, sleep onset latency, nocturnal awakenings, and daytime vitality. Interventions/Control_2 - Duration: 4 weeks (28 days), approximately 5-10 minutes per day Overall structure: A stepwise mindfulness program progressing from awareness of attention to meditation practice and generalization to daily life

Days 1-7 (Introduction and attention training) Psychoeducation on the vicious cycle between menopausal symptoms and insomnia Awareness of being caught up in thoughts and guided attention training (audio-based)

Days 8-15 (Meditation introduction) Introduction of a three-step meditation (breath, bodily sensations, thoughts/emotions)

Days 16-21 (Meditation application) Application of the three-step meditation in bedtime situations

Days 22-28 (Generalization to daily life) Mindfulness practice during everyday activities (e.g., walking, household tasks)

Eligibility: Age-lower limit - 45 years-old = Gender - Female Key inclusion criteria - 1. Presence of at least mild menopausal symptoms: total MRS score >= 5 2. Presence of at least mild insomnia symptoms: ISI score >= 8 3. Not taking prescription hypnotics from medical institutions 4. Not taking over-the-counter sleep aids Key exclusion criteria - 1. History of post-traumatic stress disorder (PTSD) or depressive disorders (including suicidal ideation) 2. Sleep disorders other than insomnia (e.g., restless legs syndrome, sleep apnea syndrome) 3. Currently receiving pharmacotherapy with hypnotics or psychotherapy for sleep problems 4. Shift work employment 5. High risk of serious consequences due to sleep deprivation (e.g., truck drivers) 6. Major life events within the past month (e.g., hospitalization, bereavement) 7. Presence of systemic underlying diseases such as cancer or intractable disorders 8. History of surgical menopause or premature menopause Target Size - 900

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 11 Day Date of IRB - 2026 Year 01 Month 14 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069208

Disclaimer: Curated by HT Syndication.