ObesityNCT06665789
Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)
A study testing Mindfulness-based Stress Reduction in people with Obesity and Polycystic Ovary Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Polycystic Ovary Syndrome, Stress
- What is being tested?
- Mindfulness-based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 18-40
- Body mass index (BMI) ≥ 40 kg/m2
- Women with a diagnosis of polycystic ovary syndrome
Who cannot join
- Psychiatric illness
- Pregnant women
- Thyroid dysfunction
- Cushing's syndrome
- Hyperprolactinemia
- Cancer history
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul, 34668
About this study
Official title: Mindfulness-Based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Obesity, Polycystic Ovary Syndrome, Stress
- Being tested
- Mindfulness-based Stress Reduction
- Keywords
- Emotional Appetite, Polycystic Ovary Syndrome, Obesity, Stress, Cognitive Triad, Mindfulness
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress ReductionBehavioural
An 8-week Mindfulness-based stress reduction training programme
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Mindfulness-based stress reduction training will be given to women selected for the experimental group for 8 weeks. Receives: Behavioral: Mindfulness-based Stress Reduction |
| Control | No intervention | Women in the control group receive routine care at the same hospital's polyclinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Imediately after participants are assigned to groups and eight weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start31 Oct 2024
- Primary completion31 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya, Saglik Bilimleri Universitesi
- Investigators
- Leyla Kaya, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665789
- Sponsor's protocol ID
- 17.04.2024/34
- Status last verified
- May 2025
- First submitted
- 29 Oct 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06665789
- Acronym / sponsor ID
- 17.04.2024/34
- Conditions
- Obesity, Polycystic Ovary Syndrome, Stress
- Keywords
- Emotional Appetite, Polycystic Ovary Syndrome, Obesity, Stress, Cognitive Triad, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mindfulness-based Stress ReductionMindfulness-based stress reduction training will be given to women selected for the experimental group for 8 weeks. |
| Control | No intervention | –Women in the control group receive routine care at the same hospital's polyclinics. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between the ages of 18-40
- Body mass index (BMI) ≥ 40 kg/m2
- Women with a diagnosis of polycystic ovary syndrome
Key exclusion criteria (11 listed)
- Psychiatric illness
- Pregnant women
- Thyroid dysfunction
- Cushing's syndrome
- Hyperprolactinemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Stress ReductionAn 8-week Mindfulness-based stress reduction training programme | Behavioural | Experimental |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla Kaya, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction in people with Obesity and Polycystic Ovary Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale (DASS 21) (time frame: Imediately after participants are assigned to groups and eight weeks later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.