NCT06836804

Brief Summary

The Cardiac Depression Scale (CDS) in both its long and short forms has been validated in various languages and populations and is used to detect depression in individuals with cardiovascular disease (CVD). However, there is no validity and reliability study of the CDS for CVD patients in the Turkish population available in the literature, which prevents its use in Turkish population. The study aims to test the validity and reliability of the Turkish version of long and short forms of the CDS in Turkish individuals with CVD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 11, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 14, 2026

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 11, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

Cardiovascular DiseasesDepression

Outcome Measures

Primary Outcomes (1)

  • Depression

    The primary outcome measure in the study is depression, as determined by the Cardiac Depression Scale (CDS), while other scales and participant demographic data will be considered as independent variables. CDS scores range from 26 to 182, with higher scores indicating more severe depressive symptoms. A score of 95 or higher on the CDS can detect major depression in individuals with CVD with 85% specificity and 97% sensitivity.

    Baseline

Study Arms (1)

Participants with CVDs

The study cohort includes participants with stable cardiovascular disease (CVD) condition who apply to outpatient cardiology clinics of Kırıkkale University Faculty of Medicine.

Other: Sociodemographic Data FormOther: Short Form Health SurveyOther: Hospital Anxiety and Depression ScaleOther: Illness Intrusiveness Ratings ScaleOther: Cardiac Depression Scale

Interventions

After inquiring about participants' sociodemographic characteristics, such as name, contact information, age, gender, marital status, education level, income, and place of residence, measurements of height, weight, and waist circumference will be obtained. Then, participants' CVD, psychiatric and other medical conditions, CVD risk factors, health history, and medications they are using will be queried. This information will be recorded in the sociodemographic data form. The sociodemographic data form has been prepared by the researchers.

Participants with CVDs

SF-36 is a self-assessment scale and can be completed in five minutes. SF-36 can evaluate both the negative and positive aspects of health. The scale consists of 36 items which are used to assess different health dimensions in 8 subscales: Physical functioning (10 items), social functioning (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items).

Participants with CVDs

The HADS was designed in 1983 to identify anxiety and depression in individuals with physical illnesses. The HADS is a self-reported scale consisting of seven items each for the anxiety and depression subscales. Each item is scored from 0 to 3, and the total score for the anxiety and depression subscales is 21 points. The overall HADS score is obtained by summing the points from both subscales. A total subscale score between 0-7 indicates a normal test result, 8-10 indicates mild anxiety or depression, 11-15 indicates moderate anxiety or depression, and 16-21 indicates severe anxiety or depression. Higher scores represent higher levels of anxiety or depression, and the total HADS score reflects an overall measure of psychological distress. The survey can be completed in 2-5 minutes.

Participants with CVDs

The IIRS is an easy-to-administer scale designed to predict the psychosocial impact of chronic illness and to document and compare the effectiveness of therapeutic interventions. It consists of 13 questions which are completed by the patient. The scale measures how the limitations imposed by chronic and life-threatening diseases hinder participation in regular activities across 13 important aspects of life: Health, diet, work, active recreation (sports), passive recreation (reading, listening to music), finances, relationships with partners, sexual life, family relationships, other social relationships, self-expression/development, religious expression, and community and civic participation.

Participants with CVDs

CDS was designed to identify depression in individuals with CVDs. It consists of 26 items across 7 subscales. The subscales address issues such as sleep, uncertainty, mood, hopelessness, immobility, anhedonia, and cognition. The CDS is rated on a 7-point Likert scale, with seven items being reverse-coded. Based on patient feedback and clinical experience, two short forms were developed, each consisting of five questions. Both short forms showed good consistency with the original CDS. The first short form includes questions from the original CDS numbered 12, 24, 21, 10, and 9. The second short form includes questions from the original CDS numbered 12, 4, 25, 21, and 7.

Participants with CVDs

Eligibility Criteria

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

The study population consists of individuals with stable CVD who are outpatients at the cardiology clinics of Kırıkkale University Faculty of Medicine.

You may qualify if:

  • Aged 18 or older and providing written consent to participate in the study
  • Diagnosed with any cardiovascular disease (coronary artery disease, peripheral artery disease, cardiomyopathy, heart failure, valve diseases, arrhythmia) and in a stable condition
  • No physical and/or mental condition that would prevent completing the scales
  • Literate in Turkish

You may not qualify if:

  • Participants who are found to have incomplete responses to the scale questions after being included in the study, as well as those who choose to withdraw from the study voluntarily, will be removed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University Faculty of Medicine

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (14)

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND
  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND
  • Thombs BD, de Jonge P, Coyne JC, Whooley MA, Frasure-Smith N, Mitchell AJ, Zuidersma M, Eze-Nliam C, Lima BB, Smith CG, Soderlund K, Ziegelstein RC. Depression screening and patient outcomes in cardiovascular care: a systematic review. JAMA. 2008 Nov 12;300(18):2161-71. doi: 10.1001/jama.2008.667.

    PMID: 19001627BACKGROUND
  • Hare DL, Selvadurai LP, Wang JQ, Yau HH, Stone MJ, Raman B, Wu N, Shi WY, Toukhsati SR. Psychometric assessment of the Cardiac Depression Scale Short Form in cardiac outpatients. Eur J Cardiovasc Nurs. 2017 Mar;16(3):249-255. doi: 10.1177/1474515116652759. Epub 2016 Jul 7.

    PMID: 27231395BACKGROUND
  • Shi WY, Stewart AG, Hare DL. Major depression in cardiac patients is accurately assessed using the cardiac depression scale. Psychother Psychosom. 2010;79(6):391-2. doi: 10.1159/000320897. Epub 2010 Sep 9. No abstract available.

    PMID: 20829653BACKGROUND
  • Wise FM, Harris DW, Carter LM. Validation of the Cardiac Depression Scale in a cardiac rehabilitation population. J Psychosom Res. 2006 Feb;60(2):177-83. doi: 10.1016/j.jpsychores.2005.07.019.

    PMID: 16439271BACKGROUND
  • Kiropoulos LA, Meredith I, Tonkin A, Clarke D, Antonis P, Plunkett J. Psychometric properties of the cardiac depression scale in patients with coronary heart disease. BMC Psychiatry. 2012 Dec 3;12:216. doi: 10.1186/1471-244X-12-216.

    PMID: 23199307BACKGROUND
  • Gholizadeh L, Salamonson Y, Davidson PM, Parvan K, Frost SA, Chang S, Hare DL. Cross-cultural validation of the Cardiac Depression Scale in Iran. Br J Clin Psychol. 2010 Nov;49(Pt 4):517-28. doi: 10.1348/014466509X478709. Epub 2010 Mar 25.

    PMID: 20346205BACKGROUND
  • Wang W, Thompson DR, Chair SY, Hare DL. A psychometric evaluation of a Chinese version of the Cardiac Depression Scale. J Psychosom Res. 2008 Aug;65(2):123-9. doi: 10.1016/j.jpsychores.2008.03.010.

    PMID: 18655856BACKGROUND
  • Hare DL, Davis CR. Cardiac Depression Scale: validation of a new depression scale for cardiac patients. J Psychosom Res. 1996 Apr;40(4):379-86. doi: 10.1016/0022-3999(95)00612-5.

    PMID: 8736418BACKGROUND
  • Sobolewska-Nowak J, Wachowska K, Nowak A, Orzechowska A, Szulc A, Plaza O, Galecki P. Exploring the Heart-Mind Connection: Unraveling the Shared Pathways between Depression and Cardiovascular Diseases. Biomedicines. 2023 Jul 5;11(7):1903. doi: 10.3390/biomedicines11071903.

    PMID: 37509542BACKGROUND
  • Feng L, Li L, Liu W, Yang J, Wang Q, Shi L, Luo M. Prevalence of depression in myocardial infarction: A PRISMA-compliant meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14596. doi: 10.1097/MD.0000000000014596.

    PMID: 30813183BACKGROUND
  • Tully PJ, Baker RA, Knight JL. Anxiety and depression as risk factors for mortality after coronary artery bypass surgery. J Psychosom Res. 2008 Mar;64(3):285-90. doi: 10.1016/j.jpsychores.2007.09.007.

    PMID: 18291243BACKGROUND
  • GBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1736-1788. doi: 10.1016/S0140-6736(18)32203-7. Epub 2018 Nov 8.

    PMID: 30496103BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDepression

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 20, 2025

Study Start

February 11, 2025

Primary Completion

November 1, 2025

Study Completion

January 1, 2026

Last Updated

April 14, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the study period will be shared.

Shared Documents
CSR

Locations