Bipolar Disorder IINCT07679204
Type D Personality and Life Satisfaction in Bipolar Disorder Type 2 and Major Depressive Disorder
An observational study of Bipolar Disorder II and Major Depressive Disorder (MDD), run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder II, Major Depressive Disorder (MDD)
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2024to 24 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Diagnosis of BD-II according to DSM-5-TR
- Remission period
- Age ≥ 18 years
- Provided informed consent
- For Bipolar Disorder Type II (BD-II) Group:
- Diagnosis of MDD according to DSM-5-TR
Show all 34Show fewer
- Remission period
- Age ≥ 18 years
- Provided informed consent
- For Major Depressive Disorder (MDD) Group:
- No psychiatric diagnosis
- No systemic or immunological illness
- Medication-free for at least one month
- Age ≥ 18 years
- Provided informed consent
- For Healthy Control (HC) Group:
- No psychiatric diagnosis
- No systemic or immunological illness
- Medication-free for at least one month
- Age ≥ 18 years
- Provided informed consent
- For Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Group:
- No psychiatric diagnosis
- No systemic or immunological illness
- Medication-free for at least one month
- Age ≥ 18 years
- Provided informed consent
- For Healthy Father and/or Mother of Major Depressive Disorder (MDD) Group:
- No psychiatric diagnosis
- No systemic or immunological illness
- Medication-free for at least one month
- Age ≥ 18 years
- Provided informed consent
- For Healthy Father and/or Mother of Healthy Control (HC) Group:
Who cannot join
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
Show all 65Show fewer
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than BD-II and not in remission for BD-II
- Alcohol/drug/substance use
- For Major Depressive Disorder (MDD) Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than MDD and not in remission for MDD
- Alcohol/drug/substance use
- For Healthy Control (HC) Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Having psychiatric disorders
- Alcohol/drug/substance use
- For Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Having psychiatric disorders
- Alcohol/drug/substance use
- For Healthy Father and/or Mother of Major Depressive Disorder (MDD) Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Having psychiatric disorders
- Alcohol/drug/substance use
- For Healthy Father and/or Mother of Healthy Control (HC) Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Having psychiatric disorders
- Alcohol/drug/substance use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Elazığ Fethi Sekin City Hospital
Elâzığ, 23200
Dilek Örüm, MD Associate Professor, +905453681686, dr.dilekulukan@gmail.com
Mehmet Hamdi Örüm, MD Associate Professor, +905382207558, mhorum@hotmail.com
About this study
Official title: Examination of Type D Personality and Factors Associated With Life Satisfaction in Parents of Patients Diagnosed With Bipolar Disorder Type 2 and Major Depressive Disorder
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.
Read the detailed description
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.
- Keywords
- Bipolar disorder type II, Major depressive disorder, Life satisfaction, Type D personality
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder Type II (BD-II) | 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). | |
| Major Depressive Disorder (MDD) | 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) | 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. | |
| Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Participant | 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. | |
| Healthy Father and/or Mother of Major Depressive Disorder (MDD) Participant | 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. | |
| Healthy Father and/or Mother of Healthy Control (HC) Participant | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At hospital admission (baseline)
Secondary outcomes (2)
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.
Measured: 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.
Measured: At hospital admission (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start23 Dec 2024
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder IIStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elazığ Mental Health and Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Hamdi ÖRÜM, Elazığ Mental Health and Diseases Hospital
- Investigators
- Mehmet Hamdi Örüm, Associate Professor, MD, Study director, Elazığ Mental Health and Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679204
- Sponsor's protocol ID
- EMHDH-2024-BD-MDD-TYPE-D
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mahmoud JS, Staten R, Hall LA, Lennie TA. The relationship among young adult college students' depression, anxiety, stress, demographics, life satisfaction, and coping styles. Issues Ment Health Nurs. 2012 Mar;33(3):149-56. doi: 10.3109/01612840.2011.632708.
PubMed 22364426Kim S, Choi M, Lee J, Kim H, Song K, Park HJ. Type D personality, cognitive illness perception, depression, approach coping, and self-management among older adults in long-term care hospitals: Structural equation modeling. Geriatr Nurs. 2022 Nov-Dec;48:150-157. doi: 10.1016/j.gerinurse.2022.09.011. Epub 2022 Oct 8.
PubMed 36219934Kendler KS, Ohlsson H, Sundquist J, Sundquist K. Risk for Mood, Anxiety, and Psychotic Disorders in Individuals at High and Low Genetic Liability for Bipolar Disorder and Major Depression. JAMA Psychiatry. 2022 Nov 1;79(11):1102-1109. doi: 10.1001/jamapsychiatry.2022.2873.
PubMed 36129716Ilhan RS, Senturk Cankorur V. [Clinical and cognitive predictors of psychosocial functioning during the euthymic period in bipolar disorder type II]. Turk Psikiyatri Derg. 2015 Spring;26(1):13-20. Turkish.
PubMed 25742033
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Type D Personality and Factors Associated With Life Satisfaction in Parents of Patients Diagnosed With Bipolar Disorder Type 2 and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07679204
- Acronym / sponsor ID
- EMHDH-2024-BD-MDD-TYPE-D
- Keywords
- Bipolar disorder type II, Major depressive disorder, Life satisfaction, Type D personality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder Type II (BD-II) | – | –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). |
| Major Depressive Disorder (MDD) | – | –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) | – | –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. |
| Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Participant | – | –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. |
| Healthy Father and/or Mother of Major Depressive Disorder (MDD) Participant | – | –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. |
| Healthy Father and/or Mother of Healthy Control (HC) Participant | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (34 listed)
Key exclusion criteria (65 listed)
- For Major Depressive Disorder (MDD) Group:
- For Healthy Control (HC) Group:
- For Healthy Father and/or Mother of Bipolar Disorder Type II (BD-II) Group:
- For Healthy Father and/or Mother of Major Depressive Disorder (MDD) Group:
- For Healthy Father and/or Mother of Healthy Control (HC) Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type D Personality Scale (DS14)
Time frame: At hospital admission (baseline)
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.
2 secondary outcomes
Brief Psychiatric Rating Scale (BPRS)
Time frame: At hospital admission (baseline)
Adult Life Satisfaction Scale (ALSS)
Time frame: At hospital admission (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 22364426Mahmoud JS, Staten R, Hall LA, Lennie TA. The relationship among young adult college students' depression, anxiety, stress, demographics, life satisfaction, and coping styles. Issues Ment Health Nurs. 2012 Mar;33(3):149-56. doi: 10.3109/01612840.2011.632708.
- Background: PubMed 36219934Kim S, Choi M, Lee J, Kim H, Song K, Park HJ. Type D personality, cognitive illness perception, depression, approach coping, and self-management among older adults in long-term care hospitals: Structural equation modeling. Geriatr Nurs. 2022 Nov-Dec;48:150-157. doi: 10.1016/j.gerinurse.2022.09.011. Epub 2022 Oct 8.
- Background: PubMed 36129716Kendler KS, Ohlsson H, Sundquist J, Sundquist K. Risk for Mood, Anxiety, and Psychotic Disorders in Individuals at High and Low Genetic Liability for Bipolar Disorder and Major Depression. JAMA Psychiatry. 2022 Nov 1;79(11):1102-1109. doi: 10.1001/jamapsychiatry.2022.2873.
- Background: PubMed 25742033Ilhan RS, Senturk Cankorur V. [Clinical and cognitive predictors of psychosocial functioning during the euthymic period in bipolar disorder type II]. Turk Psikiyatri Derg. 2015 Spring;26(1):13-20. Turkish.
- Individual participant dataSharing planned: 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.
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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.
Mehmet Hamdi Örüm, Associate Professor, MD study director
Elazığ Mental Health and Diseases Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder II and Major Depressive Disorder (MDD), run by Elazığ Mental Health and Diseases Hospital 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 34 inclusion and 65 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Hamdi Örüm, MD, Associate Professor (+905382207558, mhorum@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type D Personality Scale (DS14) (time frame: At hospital admission (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07679204, which also lists 4 linked publications.
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 1 Jul 2026.