Clinical trial NCT06665789: Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)
Official title: Mindfulness-Based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Polycystic Ovary Syndrome
Stress
Keywords: Emotional Appetite
Polycystic Ovary Syndrome
Obesity
Stress
Cognitive Triad
Mindfulness
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) program on Stress, depression, anxiety, cognitive triad and emotional appetite in obese women with polycystic ovary syndrome (PCOS).

Detailed description: The aim of this study was to evaluate the effects of mindfulness-based stress reduction (MBSR) program on stress, depression, anxiety, cognitive triad and emotional appetite in obese women with polycystic ovary syndrome (PCOS).

This study was designed as a single-blind pilot randomized controlled trial. It is planned to be conducted between November 2024 and January 2025 at Zeynep Kamil Women and Children's Diseases Education and Research Hospital.

Power analysis using G\*Power 3.0.10 showed that at least 44 samples were sufficient for 2 groups with Effect size 1. 72, 95% Power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).

Eligible women were randomized into the intervention group (n=22) and the control group (control) (n=22). Women assigned to the intervention group received the MBSR program. MBSR had eight weekly sessions of two hours each and a full-day retreat between the 7th and 8th sessions. The control group received routine care in the hospital but did not receive any other intervention during this period.

The pre-test data of the study were collected by the researcher using a face-to-face interview, a Personal Information Form containing demographic questions, and the measurement tools used in the study. At the end of the 8 weeks, the post-test data were collected using the same method.

The participants were given explanations about the MBSR program and it was stated how, for how long, and where to practice. The online MBSR program was completed by the participants in a way specific to each session (with mind, body, and breathing exercises). The MBSR program was implemented in this way for 8 weeks (eight sessions in total and one session per week). In addition, the participants were given homework (audio recording) to do throughout the week (until the next session) in the form of repeating mindfulness meditation practices. At the end of the eighth week, the measurement tools were re-administered to the participants who attended all eight sessions and completed their homework, and the post-test data were obtained.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18-40
* Body mass index (BMI) ≥ 40 kg/m2
* Women with a diagnosis of polycystic ovary syndrome

Exclusion Criteria:

* Psychiatric illness
* Pregnant women
* Thyroid dysfunction
* Cushing's syndrome
* Hyperprolactinemia
* Cancer history
* Pharmacological treatment for obesity
* Any type of bariatric surgery
* Absence of any psychiatric illness or comorbidities
* Current enrollment in a stress reduction program
* Mindfulness practice within the past 6 months (regular formal practice at least once a week)

Primary outcomes:
measure: Depression Anxiety Stress Scale (DASS 21)
timeFrame: Imediately after participants are assigned to groups and eight weeks later
measure: Emotional Appetite Questionnaire (EAQ)
timeFrame: Imediately after participants are assigned to groups and eight weeks later
measure: Ruminative Thought Style Questionnaire (RTSQ)
timeFrame: Imediately after participants are assigned to groups and eight weeks later
measure: Cognitive Triad Inventory
timeFrame: Imediately after participants are assigned to groups and eight weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Leyla Kaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: