Comparison Study of the Different Abbreviated Versions of the Geriatric Depression Scale

Depression Clinical Trial

Official title:

Comparison Study of the Different Abbreviated Versions of the Geriatric Depression Scale (GDS) in Elderly With Neurocognitive Disorders Attending Social Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180683
• Other study ID #: 20112019
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2020
• Source: Rsocialform - Geriatria, Lda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multicenter study conducted in several Portuguese institutions aims to compare the screening ability of the several Geriatric Depression Scale (GDS) validated versions for the Portuguese population (GDS-30, GDS-15, GDS-10 and GDS-5), as well as to establish their psychometric properties, using a large sample of elderly people with neurocognitive disorders attending social responses addressed to the elderly. Secondarily, cognitive state will be assessed.

Description:

Depression is the most common mental health problem among older people, both in Portugal and around the world. Due to the fast aging of the world population, depression is a significant problem, with an estimated prevalence between 8% and 16%, which is more common in institutionalized elderly. Several studies have shown the negative consequences of depression in the elderly, which has been associated with higher morbidity and mortality rates, increased use of health services and increased costs. In addition, older people's depression is associated with major disability, chronic health problems, higher suicide rates, dementia and a lower quality of life. However, it is often an unrecognized, and therefore untreated, problem. Under these circumstances, screening people at risk of depression (people with chronic illness, stroke, dementia, institutionalized or attending social responses, etc.) is a strategy with potential to reduce the impact of depression among the elderly. One of the most commonly used screening scales for depressive symptoms in elderly is the Geriatric Depression Scale (GDS), a widely known and widely used scale designed specifically for older people. For this reason, it does not include questions related to somatic symptoms, as they lack discriminatory value in older people, because they can be attributed to other physical conditions or the aging process. The original version of the scale is composed by 30 items with a dichotomous response (yes/no) assessing motivation, energy, past and future orientation, mood, cognitive complaints, anxiety and irritability. The GDS scale has good psychometric properties and has been evaluated in a wide range of geriatric populations, institutionalized patients, elderly with chronic health problems, people with dementia, etc. In order to achieve better time efficiency in its administration, the original 30-item scale was abbreviated to a 15-item version. Posteriorly, multiple shorter versions of this scale were developed, composed by one, four, five, ten or twelve items. The GDS scale has been widely translated and validated worldwide. In Portugal, the GDS-30 was adapted and validated by Pocinho, Farate, Dias, Lee and Yesavage. The versions of GDS-15, GDS-10 and GDS-5 were adapted and validated by Apóstolo and colleagues having demonstrated good psychometric properties and, therefore, potential as a screening tool for depressive symptoms in older people. The aim of this study is to compare the screening ability of the several validated versions for the Portuguese population of the GDS scale (GDS-30, GDS-15, GDS-10 and GDS-5), as well as to establish their psychometric properties, using a large sample of elderly patients attending social responses addressed to the elderly. This study will allow recommendations on which is the most sensitive GDS version for detecting depressive symptoms by comparing them with other depression screening scales. To achieve this, the results of the several GDS versions will be compared with the application of a gold standard, the Beck-II Depression Inventory [BDI-II]. Regarding the BDI-II, it is important to mention its good psychometric characteristics when used in the elderly population, which were evident in studies that compared the psychometric characteristics of different scales used to assess depression in the elderly. I was concluded that this instrument obtained a test-retest value of 0.93, Cronbach's α ranged from 0.76 to 0.91 in elderly Americans, in a community-dwelling elderly, in Puerto Rican residents, in elderly with heart problems, and in women living in institutions for the elderly. In elderly clinical samples, Cronbach's α ranged from 0.89 to 0.92. BDI is significantly and positively correlated with CES-D (r = 0.69, p <0.001) and with GDS (r = 0.71, p <0.001). The clinical utility of BDI-II is proven and high because of its clinical sensitivity and consistency with the DSM-IV criteria. In addition, it identifies many depressive symptoms and is one of the most commonly used instruments in the elderly without cognitive decline and also in non-clinical samples, as it is brief and easily administered and scored. On the other hand, in another study where BDI-II was applied to elderly people with cognitive deficits, it was found that this population has symptoms similar to those of young people and adults, supporting the validity of this instrument in this population. In order to reinforce the assessment of the screening ability of the several GDS versions validated for the Portuguese population, as well as to establish their psychometric properties, a sample (estimated at about 25%) will be defined, in which the GDS will be compared with a gold standard, that will consist of a semi-structured interview guide based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (5th ed.) for depressive disorders. For this sample, a questionnaire will be answered by the professionals who perform the evaluation, regarding their opinion about which GDS version is more easily understandable by the participants and the participants' preference regarding the different versions of GDS, as a means of assessing which version is more discernible for the participants. All the GDS versions validated for the Portuguese population (GDS-30, GDS-15, GDS-10 and GDS-5) will be administered to these participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Having a diagnosis of neurocognitive disorder according to the DSM-5 criteria and based on the MMSE scores.
• To be able to understand and answer the instruments' questions.
• Being 65 years of age or older.
• Being a native Portuguese speaker.
• To attend a social response addressed to the elderly in an institution.

Exclusion Criteria:

• Having severe sensory and physical limitations, severe disconnection from the environment, or presence of severe neuropsychiatric symptoms that make it impossible to administer the assessment battery.

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Disorder
• Disease
• Neurocognitive Disorders

Intervention

Other:
• Battery of screening tests with semi-structured interview
First, participants will be administered the Mini-Mental State Examination to assess if they meet the inclusion criteria and an ID will be assigned to the participants that meet the criteria. Posteriorly, a clinical psychologist will administer the GDS-30, GDS-15, GDS-10 and GDS-5, the BDI-II and a semi-structured interview about depressive disorders according to the DSM-5 criteria. Participants with even ID's from each institution will be answer the instruments according to the order GDS-30, GDS-10, BDI-II, GDS-5 e GDS-15 and participants with odd ID's will answer the battery in the reverse order. The assessment session will take place in a single moment in time. After the assessment, the clinical psychologist will answer a questionnaire about which version was more easily understandable by the participants and the participants' preference regarding the GDS versions.
• Battery of screening tests without semi-structured interview
First, participants will be administered the Mini-Mental State Examination to assess if they meet the inclusion criteria an ID will be assigned to the participants that meet the criteria. Posteriorly, a psychologist will administer the GDS-30, GDS-15 and the BDI-II. Participants with even ID's from each institution will answer the instruments according to the order GDS-30, BDI-II and GDS-15 and participants with odd ID's the administration order will answer the battery in the reverse order. The assessment session will take place in a single moment in time.

Locations

Country	Name	City	State
Portugal	Cediara - Associação de Solidariedade Social de Ribeira de Fráguas	Albergaria-a-Velha	Aveiro
Portugal	Centro Social e Paroquial de S. Vicente de Alcabideche	Alcabideche	Lisboa
Portugal	Centro Social de Bem-Estar de Alcanena	Alcanena	Santarém
Portugal	Santa Casa da Misericórdia de Alcobaça	Alcobaça	Leiria
Portugal	Fundação AFID Diferença	Amadora	Lisboa
Portugal	Santa Casa da Misericórdia de Alvorge	Ansião	Leiria
Portugal	Santa Casa da Misericórdia de Arronches	Arronches	Portalegre
Portugal	Santa Casa da Misericórdia de Caminha	Caminha	Viana Do Castelo
Portugal	PRODECO - Progresso e Desenvolvimento de Covões	Cantanhede	Coimbra
Portugal	Santa Casa da Misericórdia de Castelo Branco	Castelo Branco
Portugal	Cáritas de Coimbra	Coimbra
Portugal	Lar de S. José	Covilhã	Castelo Branco
Portugal	Centro Social e Paroquial de S. Martinho de Medelo	Fafe	Braga
Portugal	Santa Casa da Misericórdia de Ferreira do Alentejo	Ferreira do Alentejo	Beja
Portugal	Santa Casa da Misericórdia do Fundão	Fundão	Castelo Branco
Portugal	Fundação João Bento Raimundo	Guarda
Portugal	Quintinha da Conceição Sousa & Silva Lda	Maia	Porto
Portugal	Centro de Assistência Paroquial da Pampilhosa	Mealhada	Aveiro
Portugal	Rsocialform - Geriatria, Lda.	Mealhada	Aveiro
Portugal	Santa Casa da Misericórdia de Melgaço	Melgaço	Viana Do Castelo
Portugal	Santa Casa da Misericórdia de Canha	Montijo	Setúbal
Portugal	Santa Casa da Misericórdia de Arez	Nisa	Portalegre
Portugal	Centro Social Paroquial de Recarei	Paredes	Porto
Portugal	Associação de Desenvolvimento da Vila de Paço Sousa	Penafiel	Porto
Portugal	Associação de Solidariedade Social de Ponte de Sôr	Ponte de Sôr	Portalegre
Portugal	Lar D. Pedro V	Praia da Vitória	Açores
Portugal	Irmãs Hospitaleiras - Casa de Saúde da Idanha	Sintra	Lisboa
Portugal	Fundação Sarah Beirão/António Costa Carvalho	Tábua	Coimbra
Portugal	Santa Casa da Misericórdia de Tarouca	Tarouca	Viseu
Portugal	Fundação Luiz Bernardo de Almeida	Vale de Cambra	Aveiro
Portugal	Centro Social Vale do Homem	Vila Verde	Braga
Portugal	Santa Casa da Misericórdia de Vouzela	Vouzela	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Rsocialform - Geriatria, Lda

Country where clinical trial is conducted

Portugal, 

References & Publications (22)

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Apóstolo J, Loureiro L, Reis I, Silva I, Cardoso D, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência, IV(3): 65-73, 2014. doi:10.12707/RIV14033

Apóstolo JLA, Bobrowicz-Campos EM, Reis IA, Henriques SJ, Correia CAV. Exploring the screening capacity of the European Portuguese version of the 15-item Geriatric Depression Scale. Revista de Psicopatología y Psicología Clínica, 23(2): 99, 2018. doi:10.5944/rppc.vol.23.num.2.2018.21050

ApóstoloJ, Bobrowicz-Campos E, Reis I, Henriques S, Correia C. Screening capacity of Geriatric Depression Scale with 10 and 5 items. Revista de Enfermagem Referência, 4(16): 29-38, 2018. doi:10.12707/RIV17062

Balsamo M, Cataldi F, Carlucci L, Padulo C, Fairfield B. Assessment of late-life depression via self-report measures: a review. Clin Interv Aging. 2018 Oct 16;13:2021-2044. doi: 10.2147/CIA.S178943. eCollection 2018. Review. — View Citation

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Blazer DG. Depression in late life: review and commentary. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65. Review. — View Citation

Campos RC, Gonçalves B. The Portuguese version of the Beck Depression Inventory-II (BDI-II): Preliminary psychometric data with two nonclinical samples. European Journal of Psychological Assessment, 27(4): 258-264, 2011. doi:10.1027/1015-5759/a000072

Carvalho JO, Tan JE, Springate BA, Davis JD. Self-reported depressive syndromes in mild cognitive impairment and mild Alzheimer's disease. Int Psychogeriatr. 2013 Mar;25(3):439-44. doi: 10.1017/S1041610212001676. Epub 2012 Oct 19. — View Citation

de Sousa RD, Rodrigues AM, Gregório MJ, Branco JDC, Gouveia MJ, Canhão H, Dias SS. Anxiety and Depression in the Portuguese Older Adults: Prevalence and Associated Factors. Front Med (Lausanne). 2017 Nov 20;4:196. doi: 10.3389/fmed.2017.00196. eCollection 2017. — View Citation

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Freitas S, Simões MR, Alves L, Santana I. The Relevance of Sociodemographic and Health Variables on MMSE Normative Data. Appl Neuropsychol Adult. 2015;22(4):311-9. doi: 10.1080/23279095.2014.926455. Epub 2014 Dec 22. — View Citation

Guerreiro M, Silva AP, Botelho MA, Leitão O, Castro-Caldas A, Garcia C. Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia, 1(9): 9-10, 1994.

Jongenelis K, Pot AM, Eisses AM, Gerritsen DL, Derksen M, Beekman AT, Kluiter H, Ribbe MW. Diagnostic accuracy of the original 30-item and shortened versions of the Geriatric Depression Scale in nursing home patients. Int J Geriatr Psychiatry. 2005 Nov;20(11):1067-74. — View Citation

Morgado J, Rocha C, Maruta C, Guerreiro M, Martins I. Novos valores normativos do mini-mental state examination. Sinapse, 9, (2): 10-16, 2009.

Pocinho MTS, Farate C, Dias CA, Lee TT, Yesavage JA. Clinical and Psychometric Validation of the Geriatric Depression Scale (GDS) for Portuguese Elders. Clinical Gerontologist, 32(2): 223-236, 2009. doi:10.1080/07317110802678680

Pocklington C, Gilbody S, Manea L, McMillan D. The diagnostic accuracy of brief versions of the Geriatric Depression Scale: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2016 Aug;31(8):837-57. doi: 10.1002/gps.4407. Epub 2016 Feb 18. Review. — View Citation

Sheikh JL, Yesavage JA. Geriatric depression scale (GDS): Recent evidence and development of a shorter version. In T. L. Brink (Ed.), Clinical gerontology: A guide to assessment and intervention. New York: Hawthorne Press, 1986.

Weeks SK, McGann PE, Michaels TK, Penninx BW. Comparing various short-form Geriatric Depression Scales leads to the GDS-5/15. J Nurs Scholarsh. 2003;35(2):133-7. — View Citation

Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. — View Citation

Zhao K, Bai ZG, Bo A, Chi I. A systematic review and meta-analysis of music therapy for the older adults with depression. Int J Geriatr Psychiatry. 2016 Nov;31(11):1188-1198. doi: 10.1002/gps.4494. Epub 2016 Apr 19. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic information gathered through the sociodemographic questionnaire	Participants' answers in the sociodemographic questionnaire designed specifically for this study. It gathers information about gender, age, marital status, formal education, which social response the participant attends, medical comorbidities and cognitive symptoms and will be administered to all participants.	Baseline
Primary	Depressive symptomatology assessed through the GDS-30	Participants' scores in the GDS-30. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 30 points. Higher scores indicate more severe depressive symptoms.	Baseline
Primary	Depressive symptomatology assessed through the GDS-15	Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.	Baseline
Primary	Depressive symptomatology assessed through the GDS-10	Participants' scores in the GDS-10. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 10 points. Higher scores indicate more severe depressive symptoms.	Baseline
Primary	Depressive symptomatology assessed through the GDS-5	Participants' scores in the GDS-5. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 5 points. Higher scores indicate more severe depressive symptoms.	Baseline
Primary	Depressive symptomatology assessed through the BDI-II	Participants' scores in the BDI-II. This instrument evaluates depressive symptoms. Scores range from 0 to 63 points. Higher scores indicate more severe depressive symptoms.	Baseline
Primary	Depressive symptomatology assessed through the semi-structured interview	Participants' answers in the semi-structured interview. This interview includes questions regarding depressive symptomatology and is based on the DSM-5 criteria.	Baseline
Secondary	Cognitive state evaluated through the Mini-Mental State Examination	Participants' scores/answers in the MMSE that will allow to understand if the participants meet the inclusion criteria. MMSE is a brief cognitive screening test. Scores range between 0 - 30 points. Higher scores indicate better cognitive function. MMSE will be administered to all participants.	Baseline
Secondary	Acceptability of the instruments by the participants evaluated though the questionnaire applied to the psychologists	Psychologists answers in the questionnaire, designed specifically for this study. It will allow to understand which version is more easily understandable by the participants and their preference regarding the GDS versions. This questionnaire will only be answered by the clinical psychologists that conducted the evaluation sessions with the participants in the Semi-structured interview group.	Baseline