A Pilot Randomized Controlled Trial to Assess the Feasibility of a Sleep Cognitive Behavioural Therapy Intervention Compared to a Minimal Sleep Intervention for Improving Sleep and Lifestyle (Diet, Physical Activity and Sedentary Behaviour) Outcomes in Women with Polycystic Ovary Syndrome

Monash University0 个研究点目标入组 40 人开始时间: 2024年5月30日最近更新: 2024年8月5日

适应症

试验速览

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•For Intervention A group:
•Women aged 18-45, have a diagnosis of PCOS, live in Melbourne, not co-sleeping with children, with poor sleep quality (Pittsburgh Sleep Quality Index, global PSQI score>5), have no clinical or have subthreshold insomnia (Insomnia Severity Index, ISI score <15) and/or low risk of sleep apnea (Berlin Questionnaire, only 1 or no categories where the BQ score is positive), using medication for psychological or mental health conditions, using hormonal contraceptives/insulin sensitizers, and with normal/mild/moderate/severe scores for depression, anxiety and/or stress from the Depression Anxiety Stress Scales (DASS-21) questionnaire.
•For Intervention B group:
•Inclusion criteria are the same as per intervention A above, except that participants in this group live outside of Melbourne (within Australia).
•For Control C group:
•Inclusion criteria are the same as per intervention A above.
•For Control D group:
•Inclusion criteria are the same as per intervention B above.

•For Intervention A group:
•Women who are pregnant, live outside of Melbourne, actively trying to conceive or breastfeeding, co-sleeping with children, reproductive disorders other than PCOS, implanted cardiac devices, any history of clinical sleep conditions based on medical histories (obstructive sleep apnoea, insomnia, narcolepsy or circadian rhythm disorders), type 2 diabetes or other chronic illness that may affect study outcomes, shift workers (determined based on work schedules where working hours fall between 10:00 pm - 6:00 am), with good sleep as measured through the PSQI global score <=5, with clinical (moderate severity/severe) insomnia (ISI score >=15) and/or high risk of sleep apnea (2 or more categories where the BQ score is positive), and extremely severe scores for depression, anxiety and/or stress from the DASS-21 questionnaire.
•For Intervention B group:
•Exclusion criteria are the same as per intervention A above, except that participants in this group live outside of Melbourne (within Australia).
•For Control C group:
•Exclusion criteria are the same as per intervention A above.
•For Control D group:
•Exclusion criteria are the same as per intervention B above.

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