- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411222
Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome
The Mediating Role of Emotional Eating and Sleep Quality in the Relationship Between Mental State and Metabolic Syndrome in Individuals With Schizophrenia and Bipolar Disorder
Study Overview
Status
Detailed Description
Research Questions
- Is there a relationship between mental status and MetS in individuals with SMI?
- How does diagnosis (schizophrenia or bipolar disorder) and the group of medications used affect MetS in individuals with SMI?
- What is the level of emotional eating in individuals with SMI?
- Do emotional eating and sleep quality affect MetS in relation to mental status in individuals with SMI?
Hypotheses
H1 The group of psychotropic medications routinely used significantly affects MetS levels.
H2 Individuals with SMI have high levels of emotional eating.
H3 As mental status deteriorates, the level of emotional eating increases.
H4 Emotional eating mediates the relationship between mental status and MetS.
H5 Sleep quality mediates the relationship between mental status and MetS.
H6 Emotional eating and sleep quality mediate the relationship between mental status and MetS (multiple mediation model).
H7 As sleep quality decreases, emotional eating increases.
H8 As the level of emotional eating increases, sleep quality deteriorates, which increases the risk of metabolic syndrome.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Melisa Bulut, PhD
- Phone Number: +905348855882
- Email: melisa.bulut@ibu.edu.tr
Study Contact Backup
- Name: Nur Özgedik Turhan, Psychiatrist
- Email: drnurozgedik@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being registered with the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center,
- Having a severe chronic psychiatric illness (Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar Disorder) followed by the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center for at least 6 months,
- Being in remission (Complete Remission (Pre-Remission): Symptoms remaining below threshold values for at least 2 months (8 weeks). A state of improvement lasting more than 2 months is generally referred to as "remission"),
- Schizophrenia remission definition: 8 diagnostically significant symptoms were selected from the Positive and Negative Syndrome Scale.
- Bipolar disorder remission definition: Complete remission is defined as the absence of acute attacks and the presence of minimal/very mild symptoms.
- Being between 18-65 years of age,
- Being able to understand what is read and give written consent.
Exclusion Criteria:
- Having a diagnosis of mental retardation,
- Having other neurocognitive disorders, primarily dementia, according to DSM-V (as it can affect the ability to make decisions and give correct answers),
- Not being able to speak or understand Turkish.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic Syndrome Risk
Time Frame: Baseline
|
Participants' current metabolic syndrome risk scores will be measured using the Metabolic Syndrome Risk Index.
The total score ranges from 0 to 100.
A higher score indicates a higher risk of metabolic syndrome risk.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional eating level
Time Frame: Baseline
|
Participants' current emotional eating level scores will be measured using the Salzburg Emotional Eating Scale.
|
Baseline
|
|
Sleep quality
Time Frame: Baseline
|
Participants' current sleep quality scores will be measured using the Cumhuriyet Subjective Sleep Quality Scale.
|
Baseline
|
|
Positive and negative symptom
Time Frame: Baseline
|
Participants' current positive and negative symptom severity.
This will be measured using Positive and Negative Syndrome Scale (PANSS).
It measures the prevalence of positive and negative syndromes in schizophrenia.
Scores range from 7-49 for the Positive and Negative Scales, and from 16-112 for the General Psychopathology Scale.
The PANSS total score is a minimum of 30 and a maximum of 210.
A higher score indicates higher symptom severity.
|
Baseline
|
|
Manic symptom
Time Frame: Baseline
|
Participants' current manic symptom severity.
This will be measured using Young Mania Rating Scale.
It measures the prevalence of manic symptom in bipolar disorders.
The total score can range from 0 to 60; higher scores indicate more severe manic symptoms.
|
Baseline
|
|
Depressive symptoms
Time Frame: Baseline
|
Participants' current depressive symptoms severity.
This will be measured using Hamilton Depression Rating Scale.
It measures the prevalence of depressive symptom.
In general, the higher the total score, the more severe the depression.
HAM-D depression score levels: 10-13 mild; 14-17 mild to moderate; >17 moderate to severe; >23 very severe.
Total score ranges from 0 to 68.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zhang W, Sun Q, Chen B, Basta M, Xu C, Li Y. Insomnia symptoms are associated with metabolic syndrome in patients with severe psychiatric disorders. Sleep Med. 2021 Jul;83:168-174. doi: 10.1016/j.sleep.2021.03.030. Epub 2021 May 19.
- Zeron-Rugerio MF, Doblas-Faxeda S, Diez-Hernandez M, Izquierdo-Pulido M. Are Emotional Eating and Other Eating Behaviors the Missing Link in the Relationship between Inadequate Sleep and Obesity? A Systematic Review. Nutrients. 2023 May 12;15(10):2286. doi: 10.3390/nu15102286.
- Yan H, Huang Z, Lu Y, Qiu Y, Li M, Li J. Associations between metabolic disorders and sleep disturbance in patients with schizophrenia. Compr Psychiatry. 2023 Apr;122:152369. doi: 10.1016/j.comppsych.2023.152369. Epub 2023 Jan 21.
- Leutner M, Dervic E, Bellach L, Klimek P, Thurner S, Kautzky A. Obesity as pleiotropic risk state for metabolic and mental health throughout life. Transl Psychiatry. 2023 May 30;13(1):175. doi: 10.1038/s41398-023-02447-w.
- Laaboub N, Dubath C, Ranjbar S, Sibailly G, Grosu C, Piras M, Delessert D, Richard-Lepouriel H, Ansermot N, Crettol S, Vandenberghe F, Grandjean C, Delacretaz A, Gamma F, Plessen KJ, von Gunten A, Conus P, Eap CB. Insomnia disorders are associated with increased cardiometabolic disturbances and death risks from cardiovascular diseases in psychiatric patients treated with weight-gain-inducing psychotropic drugs: results from a Swiss cohort. BMC Psychiatry. 2022 May 17;22(1):342. doi: 10.1186/s12888-022-03983-3.
- Dakanalis A, Mentzelou M, Papadopoulou SK, Papandreou D, Spanoudaki M, Vasios GK, Pavlidou E, Mantzorou M, Giaginis C. The Association of Emotional Eating with Overweight/Obesity, Depression, Anxiety/Stress, and Dietary Patterns: A Review of the Current Clinical Evidence. Nutrients. 2023 Feb 26;15(5):1173. doi: 10.3390/nu15051173.
- Godet A, Fortier A, Bannier E, Coquery N, Val-Laillet D. Interactions between emotions and eating behaviors: Main issues, neuroimaging contributions, and innovative preventive or corrective strategies. Rev Endocr Metab Disord. 2022 Aug;23(4):807-831. doi: 10.1007/s11154-021-09700-x. Epub 2022 Jan 4.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Metabolic Diseases
- Glucose Metabolism Disorders
- Mood Disorders
- Insulin Resistance
- Hyperinsulinism
- Behavior
- Nutritional and Metabolic Diseases
- Feeding Behavior
- Communication
- Schizophrenia
- Bipolar Disorder
- Metabolic Syndrome
- Negotiating
- Emotional Eating
Other Study ID Numbers
- AIBU-PSK-MB-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States, India
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Bradley LegaRecruiting
-
Central Institute of Mental Health, MannheimRecruitingSchizophrenia | Treatment Resistant SchizophreniaGermany
-
Shanghai Zhongze Therapeutics Co., Ltd.Yale UniversityNot yet recruiting
-
Ole Köhler-ForsbergAarhus University HospitalRecruiting