NCT07679204

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 23, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Bipolar disorder type IIMajor depressive disorderLife satisfactionType D personality

Outcome Measures

Primary Outcomes (1)

  • 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.

    At hospital admission (baseline)

Secondary Outcomes (2)

  • Brief Psychiatric Rating Scale (BPRS)

    At hospital admission (baseline)

  • Adult Life Satisfaction Scale (ALSS)

    At hospital admission (baseline)

Study Arms (6)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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:

You may not qualify if:

  • 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 BD-II and not in remission for BD-II
  • Alcohol/drug/substance use
  • For Major Depressive Disorder (MDD) Group:
  • Diagnosis of MDD according to DSM-5-TR
  • Remission period
  • Age ≥ 18 years
  • Provided informed consent
  • +79 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, 23200, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22364426BACKGROUND
  • Kim 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.

    PMID: 36219934BACKGROUND
  • Kendler 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.

    PMID: 36129716BACKGROUND
  • Ilhan 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.

    PMID: 25742033BACKGROUND

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, MajorPersonal Satisfaction

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive DisorderBehavior

Study Officials

  • Mehmet Hamdi Örüm, Associate Professor, MD

    Elazığ Mental Health and Diseases Hospital

    STUDY DIRECTOR

Central Study Contacts

Mehmet Hamdi Örüm, MD, Associate Professor

CONTACT

Dilek Örüm, MD, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Mehmet Hamdi Örüm, MD, Psychiatrist

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

December 23, 2024

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations