An observational study in Bipolar Disorder II and Major Depressive Disorder (MDD), sponsored by Elazığ Mental Health and Diseases Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Elazığ Mental Health and Diseases Hospital · Observational
Bipolar Disorder Type II (BD-II) and Major Depressive Disorder (MDD) are common mood disorders associated with substantial psychological distress, impaired functioning, and reduced quality of life. BD-II is characterized by recurrent major depressive episodes and hypomanic episodes, whereas MDD is characterized by one or more major depressive episodes without a history of mania or hypomania. Both disorders have a significant genetic component, and family studies suggest that first-degree relatives may exhibit subclinical affective traits, personality characteristics, and psychosocial vulnerabilities related to these conditions. The aim of this cross-sectional study was to examine Type D personality traits and life satisfaction among patients with BD-II and MDD and parents of patients. The study recruited/will recruit 30 patients with BD-II; 30 patients with MDD; 30 healthy control subjects; mothers and/or fathers of 30 healthy control subjects, mothers and/or fathers of 30 patients with BD-II, and mothers and/or fathers of 30 patients with MDD who are in remission and receiving follow-up care at the Psychiatry Outpatient Clinic of Elazığ Fethi Sekin City Hospital, Turkey (By Dilek ÖRÜM -Associate Professor of Psychiatry, dr.dilekulukan@gmail.com). Sociodemographic characteristics, Type D personality traits, general psychiatric symptoms, and life satisfaction assessed/will be assessed using validated self-report measures, including the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS).
The primary objective was/is to compare Type D personality characteristics and life satisfaction levels between patients with MDD and BD-II and between their parents. Secondary objectives included/include investigating the associations between Type D personality traits, psychiatric symptom severity, and life satisfaction. The findings may contribute to a better understanding of familial psychological characteristics associated with mood disorders and may help identify potential psychosocial targets for preventive and supportive interventions among family members of affected individuals.
Bipolar Disorder Type II (BD-II) and Major Depressive Disorder (MDD) are chronic mood disorders that contribute substantially to global disability, psychosocial impairment, and reduced quality of life. BD-II is characterized by recurrent major depressive episodes and at least one hypomanic episode, whereas MDD is characterized by recurrent depressive episodes without a history of mania or hypomania. Although both disorders share several clinical features, they differ in course, prognosis, treatment approaches, and familial aggregation patterns. Family and twin studies have consistently demonstrated that genetic and familial factors contribute significantly to the development of mood disorders. Consequently, first-degree relatives of individuals with mood disorders may exhibit subclinical affective traits, maladaptive personality characteristics, and psychosocial difficulties even in the absence of a diagnosable psychiatric disorder.
Type D ("distressed") personality is a stable personality construct characterized by the coexistence of two major traits: negative affectivity and social inhibition. Individuals with Type D personality tend to experience persistent negative emotions while simultaneously suppressing emotional expression in social interactions. Previous studies have shown that Type D personality is associated with increased psychological distress, anxiety, depressive symptoms, poorer coping abilities, lower quality of life, and adverse health outcomes. Similarly, life satisfaction is an important indicator of subjective well-being and psychological adjustment, and it may be influenced by both personality characteristics and familial vulnerability factors.
Although Type D personality has been investigated in patients with various psychiatric disorders, including mood disorders, little is known about the prevalence and clinical significance of Type D personality traits among parents of individuals diagnosed with BD-II or MDD. Furthermore, no study has directly compared Type D personality characteristics, psychiatric symptom severity, and life satisfaction among parents of patients with these two mood disorders. Understanding these familial psychological characteristics may provide important insights into the broader psychosocial and hereditary dimensions of mood disorders.
The present study was designed as a cross-sectional observational study conducted at the Psychiatry Outpatient Clinic of Elazığ Fethi Sekin City Hospital, Turkey. All participants included in the study were/will be recruited by MD Dilek ÖRÜM (Associate Professor of Psychiatry, dr.dilekulukan@gmail.com). The study recruited/will recruit 30 patients with BD-II; 30 patients with MDD; 30 healthy control subjects; mothers and/or fathers of 30 healthy control subjects, mothers and/or fathers of 30 patients with BD-II, and mothers and/or fathers of 30 patients with MDD who are in remission and receiving follow-up care at the Psychiatry Outpatient Clinic of Elazığ Fethi Sekin City Hospital, Turkey. The psychiatric diagnoses were made according to Text Revision of Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria. To minimize the influence of acute illness-related factors, only parents of patients who are currently in remission will be included. Parents with active psychiatric disorders, a history of major psychiatric illness, significant neurological disorders affecting cognition, or severe medical illnesses will be excluded.
All participants completed/will complete a sociodemographic data form and a battery of validated psychometric instruments. Type D personality characteristics will be assessed using the Type D Personality Scale (DS14), which evaluates negative affectivity and social inhibition. General psychiatric symptom severity will be evaluated using the Brief Psychiatric Rating Scale (BPRS). Subjective well-being and life satisfaction will be assessed using the Adult Life Satisfaction Scale (ALSS). Sociodemographic variables including age, sex, marital status, and educational level will also be collected.
The primary objective of the study was/is to compare Type D personality traits and life satisfaction levels between patients with BD-II-MDD and parents of patients with BD-II and parents of patients with MDD. Secondary objectives include/d examining the relationships between Type D personality dimensions, psychiatric symptom severity, and life satisfaction within each group and across the entire sample. The study additionally aims to identify demographic and clinical factors associated with life satisfaction among parents of individuals with mood disorders.
The study hypothesizes/d that parents of patients with BD-II will demonstrate higher levels of Type D personality traits and lower levels of life satisfaction than parents of patients with MDD. It was/is also hypothesized that greater Type D personality characteristics was associated/will be associated with increased psychiatric symptoms and lower life satisfaction.
Statistical analyses will be performed using SPSS 26.version software. Descriptive statistics will summarize demographic and clinical characteristics. Group comparisons will be conducted using chi-square or Fisher's exact tests for categorical variables and independent-samples t-tests or Mann-Whitney U tests for continuous variables, depending on data distribution. Correlation and regression analyses will be performed to investigate associations between Type D personality traits, psychiatric symptoms, and life satisfaction. Statistical significance will be set at p \< 0.05.
The findings of this study may contribute to a better understanding of the familial psychological characteristics associated with mood disorders and may help identify potential targets for preventive, supportive, and psychosocial interventions among family members of affected individuals. By exploring the relationship between Type D personality and life satisfaction in parents of patients with BD-II and MDD, this study seeks to expand current knowledge regarding familial vulnerability factors and psychosocial outcomes related to mood disorders.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 180 is above the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Elazığ Mental Health and Diseases Hospital is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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The study population consisted of adult participants aged above 18 years. The bipolar disorder type II (BD-II) group included consecutive patients diagnosed with BD-II and the major depressive disorder (MDD) group included consecutive patients diagnosed with MDD according to DSM-5-TR criteria who were admitted to the psychiatry outpatient clinic of Elazığ Fethi Sekin City Hospital (Turkey). The healthy control (HC) group consisted of individuals from the general population who applied to the hospital medical board and had no current or past psychiatric or significant medical disorders. Psychiatrically healthy mothers and/or fathers of members of the BD-II, MDD, and HC groups were also included in the study. All participants provided informed consent prior to enrollment.
For Bipolar Disorder Type II (BD-II) Group:
*Inclusion Criteria:
For Bipolar Disorder Type II (BD-II) Group:
*Exclusion Criteria:
For Major Depressive Disorder (MDD) Group:
*Inclusion Criteria:
For Major Depressive Disorder (MDD) Group:
Exclusion Criteria:
For Healthy Control (HC) Group:
*Inclusion Criteria:
For Healthy Control (HC) Group:
*Exclusion Criteria:
For Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Group:
*Inclusion Criteria:
For Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Group:
*Exclusion Criteria:
For Healthy Father and/or Mother of Major Depressive Disorder (MDD) Group:
*Inclusion Criteria:
For Healthy Father and/or Mother of Major Depressive Disorder (MDD) Group:
*Exclusion Criteria:
For Healthy Father and/or Mother of Healthy Control (HC) Group:
*Inclusion Criteria:
For Healthy Father and/or Mother of Healthy Control (HC) Group:
*Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients diagnosed with Bipolar Disorder Type II (BD-II) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. Patients with BD-II must have a history of at least one hypomanic episode and one major depressive episode and must be in remission at the time of study participation, with no current hypomanic, depressive, or mixed episode. Patients with active psychiatric disorders, a history of major psychiatric disorders, significant neurological disorders affecting cognitive functioning, or severe medical illnesses excluded/will be excluded. Participants evaluated/will be evaluated once in a cross-sectional assessment. No intervention assigned/will be assigned by the study protocol. Assessments will include a sociodemographic data form, the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS).
Adult patients diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. Patients with MDD must have a history of at least one major depressive episode and must be in remission at the time of study participation, with no current major depressive episode. Patients with a current or lifetime diagnosis of bipolar disorder, schizophrenia spectrum or other psychotic disorders, active psychiatric disorders requiring immediate treatment, significant neurological disorders affecting cognitive functioning, or severe medical illnesses excluded/will be excluded. Participants evaluated/will be evaluated once in a cross-sectional assessment. No intervention assigned/will be assigned by the study protocol. Assessments will/included a sociodemographic data form, the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS).
Healthy control (HC) adult participants without any current or past psychiatric disorder enrolled/will be enrolled in the study. No intervention was administered/will be administered as part of the research protocol. Participants undergo/will undergo a baseline clinical evaluation. Clinical assessments in the HC group included/will include the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS). Sociodemographic and clinical data was recorded/will be recorded for all participants.
Adult participants without any current or past psychiatric disorder enrolled/will be enrolled in the study. No intervention was administered/will be administered as part of the research protocol. Participants undergone/will undergo a baseline clinical evaluation. Clinical assessments in the this group included/will include the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS). Sociodemographic and clinical data was recorded/will be recorded for all participants.
Adult participants without any current or past psychiatric disorder enrolled/will be enrolled in the study. No intervention was administered/will be administered as part of the research protocol. Participants undergone/will undergo a baseline clinical evaluation. Clinical assessments in the this group included/will include the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS). Sociodemographic and clinical data was recorded/will be recorded for all participants.
Adult participants without any current or past psychiatric disorder enrolled/will be enrolled in the study. No intervention was administered/will be administered as part of the research protocol. Participants undergone/will undergo a baseline clinical evaluation. Clinical assessments in the this group included/will include the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS). Sociodemographic and clinical data was recorded/will be recorded for all participants.
Type D Personality Scale (DS14)
The Type D Personality Scale (DS14) was developed by Denollet in 2005. The validity and reliability of the Turkish version among Turkish hemodialysis patients were established by Alçelik et al. The DS14 is a 14-item self-report instrument consisting of two 7-item subscales that assess Negative Affectivity (NA) (items 2, 4, 5, 7, 9, 12, and 13) and Social Inhibition (SI) (items 1, 3, 6, 8, 10, 11, and 14). Items 1 and 3 are reverse scored. Each item is rated on a 5-point Likert scale ranging from 0 ("false") to 4 ("true"), with the intermediate response options being "rather false," "neutral," and "rather true." Scores for each subscale range from 0 to 28, and a score of ≥10 on each subscale is considered the established cutoff value. In the Turkish validation study, the Cronbach's alpha coefficients were 0.82 for the Negative Affectivity subscale and 0.81 for the Social Inhibition subscale. The test-retest reliability coefficients were 0.84 and 0.78, respectively.
Time frame: At hospital admission (baseline)
Brief Psychiatric Rating Scale (BPRS)
The Brief Psychiatric Rating Scale (BPRS) is an 18-item Likert-type clinician-administered instrument with established validity and reliability in Turkish. It is used to assess the severity of psychiatric symptoms following a brief clinical interview and to evaluate treatment response over time. Higher scores indicate greater psychiatric symptom severity. The BPRS is widely used to measure the severity and changes in psychotic symptoms, as well as certain depressive symptoms, in individuals with schizophrenia, bipolar disorder, and other psychotic disorders, and to assess the effectiveness of psychiatric treatment.
Time frame: At hospital admission (baseline)
Adult Life Satisfaction Scale (ALSS)
The Adult Life Satisfaction Scale (ALSS) is a 21-item self-report instrument developed within the Turkish cultural context to assess life satisfaction in adults. The scale uses a 5-point Likert-type response format and comprises five dimensions: general life satisfaction, relationship satisfaction, self-satisfaction, satisfaction with the social environment, and job satisfaction. Total scores range from 21 to 105, with higher scores indicating greater perceived life satisfaction and more positive evaluations of one's own life. In the present study, the overall internal consistency of the ALSS was high, with a Cronbach's alpha coefficient of 0.87.
Time frame: At hospital admission (baseline)
Plan to share: Yes — Deidentified individual participant data (IPD) underlying the results reported in this study (including demographic variables, Type D Personality Scale (DS14), Brief Psychiatric Rating Scale (BPRS), Adult Life Satisfaction Scale (ALSS)) will be made available to qualified researchers upon reasonable request for academic purposes. Data will be shared after removal of all direct identifiers and in accordance with applicable ethical approvals and data protection regulations. Access to the data will require a methodologically sound research proposal and a data use agreement. Requests should be directed to the corresponding author.
Supporting information: Study protocol
Time frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
Access criteria: Access will be granted to researchers who provide a methodologically sound proposal. Requests must be approved by the principal investigator and may require a data use agreement in accordance with institutional and ethical regulations.
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Elazığ Mental Health and Diseases Hospital