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IRCT20260809070585N1 IRCT 2026-09-25 Shiraz University of Medical Sciences Effect of Mindfulness-Based Therapy Combined with Lifestyle Modification Compared with Lifestyle Modification Alone on Ovarian Appearance in Women with Polycystic Ovary Syndrome Effect of Mindfulness-Based Cognitive Therapy Combined with Lifestyle Modification versus Lifestyle Modification Alone on Ovarian Sonographic Morphology in Reproductive-Age Women with Polycystic Ovary Syndrome: A 12-Week Randomized Clinical Trial 2026-09-21 anticipated 104 Complete https://irct.ir/trial/92574 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be allocated to the two study groups using stratified block randomization with a 1:1 allocation ratio. The unit of randomization will be the individual participant. To ensure balance in participant allocation according to body mass index (BMI), randomization will be stratified into two BMI strata: BMI <30 and BMI ≥30. For each stratum, an independent random allocation sequence will be generated by an independent statistician using R statistical software and the blockrand package. Within each stratum, variable block sizes of 4 and 6 will be used, and block sizes will be randomly determined. Each block will contain an equal number of allocations to the two study groups, and the order of allocations within each block will be randomly determined by the software. After eligibility has been confirmed and the participant has formally entered the study, the participant will be assigned, according to the relevant BMI stratum, to the next available position in the allocation list for that stratum. Group assignment will then be determined according to the pre-generated random sequence. The random allocation sequence will be generated by an independent statistician, and the researcher responsible for participant recruitment will not have access to the allocation sequence during the baseline assessment. To ensure allocation concealment, the random allocation sequences for each BMI stratum will be placed in opaque, sealed, light-proof envelopes with sequential numbering. The envelopes will be prepared separately for each BMI stratum according to the allocation order. The envelope corresponding to each participant will be opened only after final confirmation of eligibility criteria, obtaining informed consent, and formal entry into the study. Therefore, group allocation cannot be predicted or altered before the participant formally enters the study, Blinding description: The statistician, radiologist (ultrasound assessor), and imaging analyst performing the AI-based ultrasound image analysis will be blinded to participants’ group allocation. Participants and the intervention provider will not be blinded due to the nature of the intervention. To maintain blinding: • DICOM files are coded and stored without reference to the intervention group prior to analysis. • The statistical dataset is analyzed using group codes (A/B) without disclosing the nature of the intervention. N/A Polycystic Ovarian Syndrome. Intervention 1: Intervention group: Lifestyle modification/Participants in this group will receive the lifestyle modification program for 12 weeks. The program will consist of 12 weekly online education and follow-up sessions. The content will include an introduction to Polycystic Ovary Syndrome (PCOS) and the principles of lifestyle modification; healthy nutrition and reducing dietary glycemic load; portion control and calorie management; meal planning and healthy snack selection; the importance and planning of physical activity; aerobic and resistance exercises; self-monitoring of diet and physical activity; prevention of relapse into unhealthy behaviors; and evaluation of goal achievement and development of a maintenance plan. Intervention 2: Intervention group: Lifestyle modification and Cognitive therapy based on mindfulness/In addition to the 12-week lifestyle modification program, participants will receive Mindfulness-Based Cognitive Therapy (MBCT). The MBCT program will be based on a standard MBCT protocol and adapted for women with Polycystic Ovary Syndrome. It will consist of eight weekly 120-minute sessions, one booster session in week 10, and daily home practice. The sessions will cover an introduction to mindfulness and mindful eating and body scan exercises; awareness of thoughts and emotions and mindful breathing; sitting meditation; identification of automatic thoughts and negative thinking patterns; stress management and acceptance of difficult emotions; mindfulness in daily activities and interpersonal interactions; self-care and prevention of relapse into maladaptive patterns; and review and consolidation of mindfulness skills. The booster session will focus on addressing barriers to practice and strengthening adherence to mindfulness exercises. The sessions and educational exercises will be delivered online. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Shaghayegh Moradi Alamdarloo
Central Building, Shiraz University of Medical Sciences, Shiraz, Zand Street, opposite Palestine Street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3230 5410 shaghayeghmoradi84@gmail.com Shiraz University of Medical Sciences scientific Shaghayegh Moradi Alamdarloo
Central Building, Shiraz University of Medical Sciences, Shiraz, Zand Street, opposite Palestine Street, Shiraz,Iran
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3230 5410 shaghayeghmoradi84@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of polycystic ovarian syndrome (PCOs) based on the Rotterdam criteria Confirmation of polycystic ovarian morphology on baseline ultrasound No use of hormonal medications over the past three months. Written informed consent Women aged 18 to 35 18 years 35 years Female Pregnancy or breastfeeding Severe psychiatric disorder Other uncontrolled endocrine disorders E28.2 Polycystic ovarian syndrome Lifestyle Behavior Intervention group: Lifestyle modification/Participants in this group will receive the lifestyle modification program for 12 weeks. The program will consist of 12 weekly online education and follow-up sessions. The content will include an introduction to Polycystic Ovary Syndrome (PCOS) and the principles of lifestyle modification; healthy nutrition and reducing dietary glycemic load; portion control and calorie management; meal planning and healthy snack selection; the importance and planning of physical activity; aerobic and resistance exercises; self-monitoring of diet and physical activity; prevention of relapse into unhealthy behaviors; and evaluation of goal achievement and development of a maintenance plan. Intervention group: Lifestyle modification and Cognitive therapy based on mindfulness/In addition to the 12-week lifestyle modification program, participants will receive Mindfulness-Based Cognitive Therapy (MBCT). The MBCT program will be based on a standard MBCT protocol and adapted for women with Polycystic Ovary Syndrome. It will consist of eight weekly 120-minute sessions, one booster session in week 10, and daily home practice. The sessions will cover an introduction to mindfulness and mindful eating and body scan exercises; awareness of thoughts and emotions and mindful breathing; sitting meditation; identification of automatic thoughts and negative thinking patterns; stress management and acceptance of difficult emotions; mindfulness in daily activities and interpersonal interactions; self-care and prevention of relapse into maladaptive patterns; and review and consolidation of mindfulness skills. The booster session will focus on addressing barriers to practice and strengthening adherence to mindfulness exercises. The sessions and educational exercises will be delivered online. Number of follicles in each ovary. Timepoint: Outcomes will be assessed at baseline, before the intervention (week 0), and immediately after completion of the 12-week intervention (week 12). Method of measurement: Radiologists and Artificial Intelligence. Ovarian Volume. Timepoint: Outcomes will be assessed at baseline, before the intervention (week 0), and immediately after completion of the 12-week intervention (week 12). Method of measurement: Radiologists and Artificial Intelligence. Perceived stress. Timepoint: Outcomes will be assessed at baseline, before the intervention (week 0), and immediately after completion of the 12-week intervention (week 12). Method of measurement: PSS questionarie. Anxiety/Depression. Timepoint: Outcomes will be assessed at baseline, before the intervention (week 0), and immediately after completion of the 12-week intervention (week 12). Method of measurement: GAD-7 and PHQ-9 questionarie. Shiraz University of Medical Sciences Approved 2026-07-21 Ethics Committee of Shiraz University of Medical Sciences Central Building, Shiraz University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)