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DepressionNCT04180683

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

An observational study of Depression and Depressive Disorder, run by Rsocialform - Geriatria, Lda at 32 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Battery of screening tests with semi-structured interview and Battery of screening tests without semi-structured interview
How many people
331 participants
Where
32 sitesPortugal
Study dates
1 Mar 2020to 30 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Portugal32 sites

  • Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

    Albergaria-a-Velha, Aveiro District, 3850-705

  • Centro Social e Paroquial de S. Vicente de Alcabideche

    Alcabideche, Lisbon District, 2645-559

  • Centro Social de Bem-Estar de Alcanena

    Alcanena, Santarém District, 2380-184

  • Santa Casa da Misericórdia de Alcobaça

    Alcobaça, Leiria District, 2460-009

  • Fundação AFID Diferença

    Amadora, Lisbon District, 2610-316

  • Santa Casa da Misericórdia de Alvorge

    Ansião, Leiria District, 3240-404

  • Santa Casa da Misericórdia de Arronches

    Arronches, Portalegre District, 7340-008

  • Santa Casa da Misericórdia de Caminha

    Caminha, Viana do Castelo District, 4910-527

  • PRODECO - Progresso e Desenvolvimento de Covões

    Cantanhede, Coimbra District, 3060-284

  • Santa Casa da Misericórdia de Castelo Branco

    Castelo Branco, 6000-773

  • Cáritas de Coimbra

    Coimbra, 3030-382

  • Lar de S. José

    Covilha, Castelo Branco District, 6200-352

  • Centro Social e Paroquial de S. Martinho de Medelo

    Fafe, Braga District, 4820-500

  • Santa Casa da Misericórdia de Ferreira do Alentejo

    Ferreira do Alentejo, Beja District, 7900-195

  • Santa Casa da Misericórdia do Fundão

    Fundão, Castelo Branco District, 6230-378

  • Fundação João Bento Raimundo

    Guarda, 6300-659

  • Quintinha da Conceição Sousa & Silva Lda

    Maia, Porto District, 4425-663

  • Rsocialform - Geriatria, Lda.

    Mealhada, Aveiro District, 3050-387

  • Centro de Assistência Paroquial da Pampilhosa

    Mealhada, Aveiro District, 3050-432

  • Santa Casa da Misericórdia de Melgaço

    Melgaço, Viana do Castelo District, 4960-570

  • Santa Casa da Misericórdia de Canha

    Montijo, Setúbal District, 2985-033

  • Santa Casa da Misericórdia de Arez

    Nisa, Portalegre District, 6050-201

  • Centro Social Paroquial de Recarei

    Paredes, Porto District, 4585-905

  • Associação de Desenvolvimento da Vila de Paço Sousa

    Penafiel, Porto District, 4560-392

  • Associação de Solidariedade Social de Ponte de Sôr

    Ponte de Sôr, Portalegre District, 7400-221

  • Lar D. Pedro V

    Praia da Vitória, Azores, 9760-438

  • Irmãs Hospitaleiras - Casa de Saúde da Idanha

    Sintra, Lisbon District, 2605-077

  • Fundação Sarah Beirão/António Costa Carvalho

    Tábua, Coimbra District, 3420-411

  • Santa Casa da Misericórdia de Tarouca

    Tarouca, Viseu District, 3610-143

  • Fundação Luiz Bernardo de Almeida

    Vale de Cambra, Aveiro District, 3730-279

  • Centro Social Vale do Homem

    Vila Verde, Braga District, 4730-263

  • Santa Casa da Misericórdia de Vouzela

    Vouzela, Viseu District, 3670-257

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Battery of screening tests with semi-structured interview, Battery of screening tests without semi-structured interview
Keywords
Depression, Depressive Disorder, Neurocognitive Disorders, Dementia, Elderly, Geriatric Depression Scale, Beck Depression Inventory - II
Medical subject headings
Depression, Depressive Disorder, Neurocognitive Disorders, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Battery of screening tests with semi-structured interviewOther

    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 interviewOther

    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.

Study groups in NCT04180683
Study groupRoleWhat they receive
Semi-structured interview groupParticipants 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.
Receives: Other: Battery of screening tests with semi-structured interview
No semi-structured interview groupParticipants assigned to this group will be administered the GDS-30 and the GDS-15, and also the BDI-II.
Receives: Other: Battery of screening tests without semi-structured interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

Secondary outcomes (2)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start1 Mar 2020
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180683
Sponsor's protocol ID
20112019
Status last verified
Nov 2020
First submitted
22 Nov 2019
Last updated
1 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anderson DN. Treating depression in old age: the reasons to be positive. Age Ageing. 2001 Jan;30(1):13-7. doi: 10.1093/ageing/30.1.13.

    PubMed 11322666

  • 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

  • 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

  • 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

  • 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.

    PubMed 30410319

  • Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

    PubMed 8991972

  • Birrer RB, Vemuri SP. Depression in later life: a diagnostic and therapeutic challenge. Am Fam Physician. 2004 May 15;69(10):2375-82.

    PubMed 15168957

  • Blazer DG. Depression in late life: review and commentary. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65. doi: 10.1093/gerona/58.3.m249.

    PubMed 12634292

  • 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.

    PubMed 23083490

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Freitas S, Simoes 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.

    PubMed 25531579

  • 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. doi: 10.1002/gps.1398.

    PubMed 16250079

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

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Depressive Disorder, run by Rsocialform - Geriatria, Lda at 32 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptomatology assessed through the GDS-30 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04180683, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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