NCT04180683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

November 22, 2019

Last Update Submit

November 30, 2020

Conditions

Keywords

DepressionDepressive DisorderNeurocognitive DisordersDementiaElderlyGeriatric Depression ScaleBeck Depression Inventory - II

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Cognitive state evaluated through the Mini-Mental State Examination

    Baseline

  • Acceptability of the instruments by the participants evaluated though the questionnaire applied to the psychologists

    Baseline

Other Outcomes (1)

  • Sociodemographic information gathered through the sociodemographic questionnaire

    Baseline

Study Arms (2)

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

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

Interventions

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.

Semi-structured interview group

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.

No semi-structured interview group

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

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

Location

Rsocialform - Geriatria, Lda.

Mealhada, Aveiro District, 3050-387, Portugal

Location

Centro de Assistência Paroquial da Pampilhosa

Mealhada, Aveiro District, 3050-432, Portugal

Location

Fundação Luiz Bernardo de Almeida

Vale de Cambra, Aveiro District, 3730-279, Portugal

Location

Lar D. Pedro V

Praia da Vitória, Azores, 9760-438, Portugal

Location

Santa Casa da Misericórdia de Ferreira do Alentejo

Ferreira do Alentejo, Beja District, 7900-195, Portugal

Location

Centro Social e Paroquial de S. Martinho de Medelo

Fafe, Braga District, 4820-500, Portugal

Location

Centro Social Vale do Homem

Vila Verde, Braga District, 4730-263, Portugal

Location

Lar de S. José

Covilha, Castelo Branco District, 6200-352, Portugal

Location

Santa Casa da Misericórdia do Fundão

Fundão, Castelo Branco District, 6230-378, Portugal

Location

PRODECO - Progresso e Desenvolvimento de Covões

Cantanhede, Coimbra District, 3060-284, Portugal

Location

Fundação Sarah Beirão/António Costa Carvalho

Tábua, Coimbra District, 3420-411, Portugal

Location

Santa Casa da Misericórdia de Alcobaça

Alcobaça, Leiria District, 2460-009, Portugal

Location

Santa Casa da Misericórdia de Alvorge

Ansião, Leiria District, 3240-404, Portugal

Location

Centro Social e Paroquial de S. Vicente de Alcabideche

Alcabideche, Lisbon District, 2645-559, Portugal

Location

Fundação AFID Diferença

Amadora, Lisbon District, 2610-316, Portugal

Location

Irmãs Hospitaleiras - Casa de Saúde da Idanha

Sintra, Lisbon District, 2605-077, Portugal

Location

Santa Casa da Misericórdia de Arronches

Arronches, Portalegre District, 7340-008, Portugal

Location

Santa Casa da Misericórdia de Arez

Nisa, Portalegre District, 6050-201, Portugal

Location

Associação de Solidariedade Social de Ponte de Sôr

Ponte de Sôr, Portalegre District, 7400-221, Portugal

Location

Quintinha da Conceição Sousa & Silva Lda

Maia, Porto District, 4425-663, Portugal

Location

Centro Social Paroquial de Recarei

Paredes, Porto District, 4585-905, Portugal

Location

Associação de Desenvolvimento da Vila de Paço Sousa

Penafiel, Porto District, 4560-392, Portugal

Location

Centro Social de Bem-Estar de Alcanena

Alcanena, Santarém District, 2380-184, Portugal

Location

Santa Casa da Misericórdia de Canha

Montijo, Setúbal District, 2985-033, Portugal

Location

Santa Casa da Misericórdia de Caminha

Caminha, Viana do Castelo District, 4910-527, Portugal

Location

Santa Casa da Misericórdia de Melgaço

Melgaço, Viana do Castelo District, 4960-570, Portugal

Location

Santa Casa da Misericórdia de Tarouca

Tarouca, Viseu District, 3610-143, Portugal

Location

Santa Casa da Misericórdia de Vouzela

Vouzela, Viseu District, 3670-257, Portugal

Location

Santa Casa da Misericórdia de Castelo Branco

Castelo Branco, 6000-773, Portugal

Location

Cáritas de Coimbra

Coimbra, 3030-382, Portugal

Location

Fundação João Bento Raimundo

Guarda, 6300-659, Portugal

Location

Related Publications (22)

  • 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.

    PMID: 11322666BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 30410319BACKGROUND
  • 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.

    PMID: 8991972BACKGROUND
  • Birrer RB, Vemuri SP. Depression in later life: a diagnostic and therapeutic challenge. Am Fam Physician. 2004 May 15;69(10):2375-82.

    PMID: 15168957BACKGROUND
  • 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.

    PMID: 12634292BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23083490BACKGROUND
  • 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.

    PMID: 1202204BACKGROUND
  • 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.

    PMID: 25531579BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16250079BACKGROUND
  • Morgado J, Rocha C, Maruta C, Guerreiro M, Martins I. Novos valores normativos do mini-mental state examination. Sinapse, 9, (2): 10-16, 2009.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 26890937BACKGROUND
  • 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.

    BACKGROUND
  • de Sousa RD, Rodrigues AM, Gregorio MJ, Branco JDC, Gouveia MJ, Canhao 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.

    PMID: 29209612BACKGROUND
  • 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. doi: 10.1111/j.1547-5069.2003.00133.x.

    PMID: 12854293BACKGROUND
  • 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. doi: 10.1016/0022-3956(82)90033-4.

    PMID: 7183759BACKGROUND
  • 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.

    PMID: 27094452BACKGROUND

MeSH Terms

Conditions

DepressionDepressive DisorderNeurocognitive DisordersDementia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

    Universidade da Coruña

    PRINCIPAL INVESTIGATOR
  • Fernando L Vázquez González, PhD

    University of Santiago de Compostela

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 27, 2019

Study Start

March 1, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations