A Sleep Intervention for Improving Sleep and Lifestyle (Diet, Physical Activity and Sedentary Behaviour) in Women with Polycystic Ovary Syndrome

This is a pragmatic Randomised Controlled Trial (RCT) that will evaluate the feasibility of a sleep cognitive behavioural therapy (CBT) intervention compared to a minimal intervention control in real-life routine practice conditions without intervening with participants usual care or treatment. Participants are required to commit for a total of 13-weeks throughout the duration of the study. The trial will recruit n = 40 participants with PCOS who attend the Monash Health PCOS clinic and be randomised into either the sleep CBT intervention group (n = 20) or the minimal intervention control group (n = 20). The sleep CBT intervention will be administered by trained healthcare professionals such as accredited practising Dietitians. The sleep CBT intervention groups comprise of Intervention A group (In-person intervention delivery with the option of over-the-phone) or Intervention B group (remote online delivery only). Depending on where the participant lives, if they live in Melbourne, they will be assigned to Intervention A group as this requires them to attend some of the sessions face-to-face at Monash University and some sessions online via telehealth (Zoom) or over-the-phone with the research team. If the participant lives outside of Melbourne (within Australia), they will be assigned to Intervention B group as this requires them to attend all sessions remotely online via telehealth (Zoom) or over-the-phone. Research activities for the Intervention A or B groups: I) Routine collected data from medical records: All Intervention groups will have their routine collected data from PCOS clinic Monash Health medical records retrieved by the research team to assess PCOS diagnosis, anthropometric data, clinical and biochemical data. Baseline blood samples will be collected from the PCOS clinic as part of routine care and the following hormones are of interest: prolactin, 17-oh-progesterone, Thyroid Stimulating Hormone, Follicular Stimulating Hormone, Luteinizing Hormone, biochemical hyperandrogenism (Testosterone, sex hormone binding globulin (SHBG)). ii) Menstrual cyclicity: All intervention groups will be asked to retrospectively report for 3 months their menses using a menses calendar and track their cycle throughout the study. Participants will be given the option to complete the menses calendar online or in hard copy. iii) Sleep quality and quantity: Actigraphy (Actiwatch Spectrum Pro, Phillips) will only be given to the Intervention A group in-between study sessions. Participants to worn for 7 days and used to collect actigraphy data. To aid data cleaning the participants will also complete a 7-day sleep diary. iv) Sleep CBT intervention: The sleep CBT intervention will be based on capability, opportunity and motivation–behaviour (COM-B) principles to support behaviour change for the participant (and bed partner if applicable) (1). This will be based on promoting healthy sleep practices delivered through four one-to-one over-the-phone or telehealth personalised sessions for 30-35 minutes each session at 0 (i.e., baseline), 2, 6, 10-12 weeks, followed up by a sheet to take home with a summary of the discussion. It will discuss in non-scientific terms the importance of sleep for overall health and wellbeing and the link between sleep, lifestyle, diet and chronic disease. There will be core components of the intervention including i) stimulus control, ii) encouraging a balanced attitude to sleep and iii) dealing with night-time worries. These will be provided in a stepwise approach through the intervention sessions. Elective components that can be selected from the Centre for Clinical Investigation Sleep Information sheet (2) and sleep support in isolation from Monash and Stanford Universities (3). These information sheets will be used as a basis of self-selecting sleep goals to drive behaviour change. Goals will be formulated according to SMART (specific, measurement, achievable, relevant and time-limited) principles. Weekly personalised and generic text messages (for 12-weeks) with tips about sleep behaviour will also be sent to the participant relating to goals set at intervention meeting. v) Survey questionnaires: Online questionnaires on demographics, sleep, diet, mental health, quality of life, physical activity will be provided to all participants in the intervention groups upon enrolment into the study and during several visit study timepoints and where possible will be completed and returned to the researcher on the same day. Participants will be provided the option to complete these questionnaires in hard copy or electronically. vi) Semi-structured interviews: Exit interview and (optional) focus group discussions at the end of trial to identify barriers and enablers to the sleep CBT intervention goals and to test the feasibility of the intervention. Behaviour change wheel of COM-B model will be explored during goal setting. For intervention A group (Sleep CBT intervention delivery in-person or over-the-phone): Participants will be asked to attend five study visits with the research team that includes two face-to-face and three over-the-phone or online via telehealth Zoom meetings at week-0 (for 2 to 3 hours), week-2 (for 30-35 minutes), week-6 (for 2 to 3 hours), week-10 to 12 (for 30-35 minutes), and week-13 (for 2 to 3 hours). Four out of five of these study visits will involve sleep CBT intervention consultation sessions by trained health professionals like Dietitians for 30-35 minutes per session at 0, 2, 6, 10-12 weeks. Participants will also receive weekly text messages for 12-weeks with tips about sleep behaviour relating to goals set at intervention sessions. Other study assessments will be administered by the research team that include sleep actigraphy (Actiwatch device) with sleep diary and survey questionnaires on demographics, sleep, diet, mental health, quality of life, physical activity, and menstrual cyclicity. The Actiwatch device may also be given out to the participants in-between study visits. An exit interview and (optional) focus group discussions at the end of trial administered by trained health professionals and/or study researchers, will identify barriers and enablers to the sleep CBT intervention goals and to test the feasibility of the intervention. Behaviour change wheel of COM-B model will be explored during goal setting. The estimated total time commitment to complete all study assessments (10 hours) and intervention delivery (3 hours) is 13 hours. For intervention B group (Sleep CBT intervention delivery remote online): There will be no in-person and sleep actigraphy measurements. All other data collection measures will be the same as per Intervention A group above, but will be administered online. Participants will be asked to attend five study visits with the research team over-the-phone or online via telehealth Zoom meetings at week-0 (for 2 to 3 hours), week-2 (for 30-35 minutes), week-6 (for 2 to 3 hours), week-10 to 12 (for 30-35 minutes), and week-13 (for 2 to 3 hours). Four out of five of these study visits will involve remote online sleep intervention consultation sessions by trained health professionals like Dietitians for 30-35 minutes per session at 0, 2, 6, 10-12 weeks. Participants will also receive weekly text messages for 12-weeks with tips about sleep behaviour relating to goals set at intervention sessions. Other study assessments will be administered by the research team that include survey questionnaires about demographics, sleep, diet, mental health, quality of life, physical activity, and menstrual cyclicity. An exit interview and (optional) focus group discussions at the end of trial administered by trained health professionals and/or study researchers, will identify barriers and enablers to the sleep CBT intervention goals and to test the feasibility of the intervention. Behaviour change wheel of COM-B model will be explored during goal setting. The estimated total time commitment to complete all study assessments (10 hours) and intervention delivery (3 hours) is 13 hours. No specific training is needed prior to the first participant enrolment. since health professionals (Dietitians) involve in this study are qualified researchers with the skills and knowledge required to administer the sleep-CBT intervention and provide support during the study assessments. Strategies used to monitor adherence to the intervention include using feasibility checklists for researchers to track at each study timepoint. These feasibility (intervention and text messages) checklists will capture participants completion of intervention components delivered by health professionals. At each intervention meeting, the health professional will discuss with the participant, their ability to adhere to the goals set in the previous session and explore any barriers and enablers. References: (1) Michie S, Van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implementation science. 2011;6(1):1-12. (2) Centre for Clinical Interventions. Sleep Hygiene Centre for Clinical Interventions. doi:https://www.cci.health.wa.gov.au/~/media/CCI/Mental-Health-Professionals/Sleep/Sleep---Information-Sheets/Sleep-Information-Sheet---04---Sleep-Hygiene.pdf Accessed 12 August 2023. (3) Bei B RS, Drummond S, Manber R. Sleeping tips when staying indoors during isolation period 2020. doi:https://github.com/beisci/SleepInfo/blob/master/sleep_in_isolation.md Accessed 12 August 2023.