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

Sponsor
Rsocialform - Geriatria, Lda (Other)
Overall Status
Completed
CT.gov ID
NCT04180683
Collaborator
(none)
331
32
9
10.3
1.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Battery of screening tests with semi-structured interview
  • Other: Battery of screening tests without semi-structured interview

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 Design

Study Type:
Observational
Actual Enrollment :
331 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Comparison Study of the Different Abbreviated Versions of the Geriatric Depression Scale (GDS) in Elderly With Neurocognitive Disorders Attending Social Responses
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Depressive symptomatology assessed through the GDS-30 [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.

  2. Depressive symptomatology assessed through the GDS-15 [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.

  3. Depressive symptomatology assessed through the GDS-10 [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.

  4. Depressive symptomatology assessed through the GDS-5 [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.

  5. Depressive symptomatology assessed through the BDI-II [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.

  6. Depressive symptomatology assessed through the semi-structured interview [Baseline]

    Participants' answers in the semi-structured interview. This interview includes questions regarding depressive symptomatology and is based on the DSM-5 criteria.

Secondary Outcome Measures

  1. Cognitive state evaluated through the Mini-Mental State Examination [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.

  2. Acceptability of the instruments by the participants evaluated though the questionnaire applied to the psychologists [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.

Other Outcome Measures

  1. Sociodemographic information gathered through the sociodemographic questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Rsocialform - Geriatria, Lda

Investigators

  • Principal Investigator: Susana I Justo Henriques, PhD, Cediara and Nursing School of Coimbra
  • 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: Patrícia Otero Otero, PhD, University of A Coruña
  • Principal Investigator: Fernando L Vázquez González, PhD, University of Santiago de Compostela

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rsocialform - Geriatria, Lda
ClinicalTrials.gov Identifier:
NCT04180683
Other Study ID Numbers:
  • 20112019
First Posted:
Nov 27, 2019
Last Update Posted:
Dec 1, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rsocialform - Geriatria, Lda
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2020