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

NCT06665789 | Completed

• 1 other identifier: 17.04.2024/34
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Polycystic Ovary Syndrome; Stress

Keywords

Emotional Appetite; Polycystic Ovary Syndrome; Obesity; Stress; Cognitive Triad; Mindfulness

Outcome Measures

Primary Outcomes (4)

• Depression Anxiety Stress Scale (DASS 21)

  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.

  Imediately after participants are assigned to groups and eight weeks later

• Emotional Appetite Questionnaire (EAQ)

  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.

  Imediately after participants are assigned to groups and eight weeks later

• Ruminative Thought Style Questionnaire (RTSQ)

  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.

  Imediately after participants are assigned to groups and eight weeks later

• Cognitive Triad Inventory

  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.

  Imediately after participants are assigned to groups and eight weeks later

Study Arms (2)

Experimental

EXPERIMENTAL

Mindfulness-based stress reduction training will be given to women selected for the experimental group for 8 weeks.

Behavioral: Mindfulness-based Stress Reduction

Control

NO INTERVENTION

Women in the control group receive routine care at the same hospital's polyclinics.

Interventions

Mindfulness-based Stress Reduction BEHAVIORAL

An 8-week Mindfulness-based stress reduction training programme

Experimental

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Famale
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

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

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Polycystic Ovary Syndrome

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leyla Kaya, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: October 31, 2024
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)