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

November 30, 2020 updated by: Rsocialform - Geriatria, Lda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Castelo Branco, Portugal, 6000-773
        • Santa Casa da Misericórdia de Castelo Branco
      • Coimbra, Portugal, 3030-382
        • Cáritas de Coimbra
      • Guarda, Portugal, 6300-659
        • Fundação João Bento Raimundo
    • Aveiro
      • Albergaria-a-Velha, Aveiro, Portugal, 3850-705
        • Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
      • Mealhada, Aveiro, Portugal, 3050-387
        • Rsocialform - Geriatria, Lda.
      • Mealhada, Aveiro, Portugal, 3050-432
        • Centro de Assistência Paroquial da Pampilhosa
      • Vale de Cambra, Aveiro, Portugal, 3730-279
        • Fundação Luiz Bernardo de Almeida
    • Açores
      • Praia da Vitória, Açores, Portugal, 9760-438
        • Lar D. Pedro V
    • Beja
      • Ferreira do Alentejo, Beja, Portugal, 7900-195
        • Santa Casa da Misericórdia de Ferreira do Alentejo
    • Braga
      • Fafe, Braga, Portugal, 4820-500
        • Centro Social e Paroquial de S. Martinho de Medelo
      • Vila Verde, Braga, Portugal, 4730-263
        • Centro Social Vale do Homem
    • Castelo Branco
      • Covilhã, Castelo Branco, Portugal, 6200-352
        • Lar de S. José
      • Fundão, Castelo Branco, Portugal, 6230-378
        • Santa Casa da Misericórdia do Fundão
    • Coimbra
      • Cantanhede, Coimbra, Portugal, 3060-284
        • PRODECO - Progresso e Desenvolvimento de Covões
      • Tábua, Coimbra, Portugal, 3420-411
        • Fundação Sarah Beirão/António Costa Carvalho
    • Leiria
      • Alcobaça, Leiria, Portugal, 2460-009
        • Santa Casa da Misericórdia de Alcobaça
      • Ansião, Leiria, Portugal, 3240-404
        • Santa Casa da Misericórdia de Alvorge
    • Lisboa
      • Alcabideche, Lisboa, Portugal, 2645-559
        • Centro Social e Paroquial de S. Vicente de Alcabideche
      • Amadora, Lisboa, Portugal, 2610-316
        • Fundação AFID Diferença
      • Sintra, Lisboa, Portugal, 2605-077
        • Irmãs Hospitaleiras - Casa de Saúde da Idanha
    • Portalegre
      • Arronches, Portalegre, Portugal, 7340-008
        • Santa Casa da Misericórdia de Arronches
      • Nisa, Portalegre, Portugal, 6050-201
        • Santa Casa da Misericórdia de Arez
      • Ponte de Sôr, Portalegre, Portugal, 7400-221
        • Associação de Solidariedade Social de Ponte de Sôr
    • Porto
      • Maia, Porto, Portugal, 4425-663
        • Quintinha da Conceição Sousa & Silva Lda
      • Paredes, Porto, Portugal, 4585-905
        • Centro Social Paroquial de Recarei
      • Penafiel, Porto, Portugal, 4560-392
        • Associação de Desenvolvimento da Vila de Paço Sousa
    • Santarém
      • Alcanena, Santarém, Portugal, 2380-184
        • Centro Social de Bem-Estar de Alcanena
    • Setúbal
      • Montijo, Setúbal, Portugal, 2985-033
        • Santa Casa da Misericórdia de Canha
    • Viana Do Castelo
      • Caminha, Viana Do Castelo, Portugal, 4910-527
        • Santa Casa da Misericórdia de Caminha
      • Melgaço, Viana Do Castelo, Portugal, 4960-570
        • Santa Casa da Misericórdia de Melgaço
    • Viseu
      • Tarouca, Viseu, Portugal, 3610-143
        • Santa Casa da Misericórdia de Tarouca
      • Vouzela, Viseu, Portugal, 3670-257
        • Santa Casa da Misericórdia de Vouzela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In each participanting institution, users who meet the inclusion criteria will be selected to answer the assessment instruments. Prior to the inclusion in the study, informed consent will be obtained from participants or their caregivers after they have received information about the study. This information will include the purpose of the study, the data processing in accordance with current legislation, the voluntary nature of the participation in the study and the right to withdraw consent at any time without affecting the services received in the institution.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Semi-structured interview group
Participants assigned to this group will be administered the GDS-30, GDS-15, GDS-10 nad GDS-5, and also the BDI-II and a semi-structured interview based on the DSM-5 criteria. The psychologists performing the assessment will answer a questionnaire about which GDS version was more easily understandable by the participants and the participants' preference regarding the GDS versions.
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.
No semi-structured interview group
Participants assigned to this group will be administered the GDS-30 and the GDS-15, and also the BDI-II.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptomatology assessed through the GDS-30
Time Frame: Baseline
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
Depressive symptomatology assessed through the GDS-15
Time Frame: Baseline
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
Depressive symptomatology assessed through the GDS-10
Time Frame: Baseline
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
Depressive symptomatology assessed through the GDS-5
Time Frame: Baseline
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
Depressive symptomatology assessed through the BDI-II
Time Frame: Baseline
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
Depressive symptomatology assessed through the semi-structured interview
Time Frame: Baseline
Participants' answers in the semi-structured interview. This interview includes questions regarding depressive symptomatology and is based on the DSM-5 criteria.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive state evaluated through the Mini-Mental State Examination
Time Frame: Baseline
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
Acceptability of the instruments by the participants evaluated though the questionnaire applied to the psychologists
Time Frame: Baseline
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic information gathered through the sociodemographic questionnaire
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rsocialform - Geriatria, Lda

Investigators

  • Principal Investigator: Enrique Pérez Saéz, PhD, CRE Alzheimer and University of Salamanca
  • Principal Investigator: João L Alves Apóstolo, PhD, Nursing School of Coimbra
  • Principal Investigator: Susana I Justo Henriques, PhD, Cediara and Nursing School of Coimbra
  • Principal Investigator: Patricia Otero Otero, PhD, University of A Coruna
  • Principal Investigator: Fernando L Vázquez González, PhD, University of Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20112019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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