Insomnia Symptoms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index: ISI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pittsburgh Sleep Quality Index: PSQI 2. Menopause Rating Scale: MRS 3. Work Functioning Impairment scale: WFun 4. Generalized Anxiety Disorder-7: GAD-7 5. Patient Health Questionnaire-9: PHQ-9 6. Five Facet Mindfulness Questionnaire: FFMQ 7. Cognitive Fusion Questionnaire: CFQ-7 | — |
Countries
Japan
Contacts
Akita University Department of Environmental Health Science and Public Health, Graduate School of Medicine