Clinical trial NCT06836804: Validity and Reliability of the Turkish Version of the Cardiac Depression Scale
Official title: Validity and Reliability Study of the Turkish Long and Short Forms of the Cardiac Depression Scale
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiovascular Diseases
Depression
Keywords: Cardiovascular Diseases
Depression
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed description: CVDs are among the leading causes of death worldwide and in Türkiye. Studies have shown that the prevalence of depression is higher among individuals with CVD compared to the general population. For example, higher rates of depression have been reported in patients who have undergone coronary bypass surgery, individuals who experienced myocardial infarction, and those with angina pectoris. Depression itself can be a cause of CVD, while CVD can also trigger depressive symptoms.

The presence of depression in individuals with CVD is associated with diverse adverse outcomes including mortality. Therefore, routine depression screening is recommended for individuals with CVD. Many scales are currently used in clinical practice for depression screening. The CDS was specifically developed in 1996 for individuals with CVD and remains the only scale in the literature designed for this purpose. The CDS consists of 26 self-administered items and is used to identify and assess the severity of depressive symptoms, including emotional, cognitive, and somatic characteristics. Originally developed in English in Australia, the scale has undergone validity and reliability studies for individuals with different CVD conditions across various languages and cultures. The CDS takes approximately five minutes to administer and score, and demonstrates robust psychometric properties in distinguishing mild, moderate, and severe depression. 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.

Due to constraints such as time, resources, and personnel in clinical practice, two shorter forms of the CDS have been developed, each consisting of five items derived from the original scale. These short forms have also been validated in English for different CVD populations. However, no validity or reliability study of the CDS, in either its long or short forms, has been studied in Turkish population. Furthermore, the short forms of the CDS have not undergone validity and reliability analyses in any language other than English.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Individuals who do not meet the inclusion criteria will be excluded.
* 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.

Primary outcomes:
measure: Depression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University Faculty of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.