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Completed

NCT Number: NCT06665789

Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)

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).

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Key information

Conditions

Obesity Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Stress Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

An 8-week Mindfulness-based stress reduction training programme

Primary outcomes

  1. Depression Anxiety Stress Scale (DASS 21)

    Time frame: Imediately after participants are assigned to groups and eight weeks later

    In this scale (DASS-21), there are 7 questions each to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert Type Scale; 0 -3. Depression, anxiety and stress scores are measured by summing the scores of the related items. A minimum of 0 and a maximum of 21 points can be obtained in each dimension.

  2. Emotional Appetite Questionnaire (EAQ)

    Time frame: Imediately after participants are assigned to groups and eight weeks later

    In this questionnaire, the presence of emotional eating is assessed in negative/positive emotions (14 items) and situations (8 items). The negative total score is obtained by adding and averaging the scores of negative emotions and negative situations (EAQ), and the positive total score is obtained by adding and averaging the scores of positive emotions and positive situations (EAQ). This scale, which does not have a cut-off score for emotional eating, analyzes the emotions and situations in which emotional eating behavior can occur specifically.

  3. Ruminative Thought Style Questionnaire (RTSQ)

    Time frame: Imediately after participants are assigned to groups and eight weeks later

    It is a 20-item 7-point Likert-type scale (1=does not describe me at all, 7=describes me very well). There is no cut-off score for the scale result. The minimum score can be 20 and the maximum can be 140, and the results only show the tendency for ruminative thinking. As the score increases, it can be said that the person's ruminative thinking style is intense. This scale tries to evaluate the general way of thinking of the person without taking into account the person's current emotional state and without dividing it into subscales. This shows that the scale can be used in all psychopathological disorders. Since it is not related to any psychopathology, the total score does not indicate psychiatric disorders.

  4. Cognitive Triad Inventory

    Time frame: Imediately after participants are assigned to groups and eight weeks later

    In the seven-point Likert-type form consisting of 36 items, one option is marked for each item between "I do not agree at all" (1) and "I completely agree" (7). When scoring the items, all negative items are reverse coded and low scores from the scale reflect the negative cognitive triad, while high scores reflect the positive cognitive triad.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Mindfulness-Based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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