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"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults

8. juni 2021 oppdatert av: Shefaly Shorey, National University, Singapore

"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial

The World Health Organization (WHO) reported that approximately 15% of adults aged 60 and above suffer from some form of mental disorder, with one of the most common neuropsychiatric disorders being depression. Similar trends are seen in Singapore where 11.4% of the older adults aged 65 and above had depressive symptoms. Another population survey conducted among elderly in Singapore showed that elderly with subsyndromal depression (SSD) were similar to or worse than elderly with Major Depressive Disorder (MDD). However being a multi-ethnic Asia society the mental conditions such as depression and anxiety are seen as taboo topics to be discussed more so to seek help or treatment for these conditions in Singapore. Additionally scarcity of trained psychiatrists and work load of these trained professionals in the acute care settings make it difficult to reach these needy older adults. Hence, it is imperative to support the needs of this group of community dwelling older adults to ensure that their emotional wellbeing, and their condition do not progress to MDD. As such, this is the first of its kind study that will evaluate the effectiveness of solution focused brief therapy delivered by the lay mindfulness practitioner and the nurses.

If the pilot intervention is found to be feasible and effective, the large scale community trial will be planned to reach to more elderly in Singapore to help them age in a dignified way. In addition, other countries that do not involve lay mindfulness practitioners and nurses to provide integrated personal therapy in the community may benefit from this study as well.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Singapore
      • Singapore, Singapore, 117597
        • National University of Singapore

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år til 95 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Community-dwelling older adults aged between 60-95 years old
  • Able to understand and speak either English and/or Mandarin
  • Able to attend at least 80% (five out of seven sessions) of the intervention sessions
  • Have subsyndromal depression (obtained a score between one and five on the Geriatric Depression Scale) and/or subsyndromal anxiety (obtained a score between three and 10 on the Geriatric Anxiety Scale)

Exclusion Criteria:

  • Older adults aged between 60-95 years old without subsyndromal depression and/or subsyndromal anxiety
  • Older adults aged between 60-95 years old who could not understand or speak either English and/or Mandarin.
  • Older adults aged between 60-95 years old who were unable to attend at least 80% (five out of seven sessions) of the intervention sessions.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Styre
Ingen inngrep
Eksperimentell: Where-there-is-no-psychiatrist Integrated Personal Therapy (WIPT)
Solution-focused brief therapy (SFBT) involving psychoeducation and structured life review therapy, as well as mindfulness-based training
Atferdsmessig: Where-there-is-no-psychiatrist Integrated Personal Therapy (WIPT)
The WIPT include weekly face-to-face group sessions including mindfulness-based training and solution focused brief therapy (SFBT) involving psychoeducation and structured life review therapy catered to the personal needs of the participants.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Symptoms of depression
Tidsramme: Prior to start of intervention
Measured using Geriatric Depression Scale. 15-item scale where participants select either "Yes" or "No" in response to 15 statements. The maximum score that could be obtained was 15 points; a high score on the scale indicates severe depressive symptoms.
Prior to start of intervention
Symptoms of depression
Tidsramme: 3 months post-recruitment
Measured using Geriatric Depression Scale. 15-item scale where participants select either "Yes" or "No" in response to 15 statements. The maximum score that could be obtained was 15 points; a high score on the scale indicates severe depressive symptoms.
3 months post-recruitment
Symptoms of depression
Tidsramme: 6 months post-recruitment
Measured using Geriatric Depression Scale. 15-item scale where participants select either "Yes" or "No" in response to 15 statements. The maximum score that could be obtained was 15 points; a high score on the scale indicates severe depressive symptoms.
6 months post-recruitment
Symptoms of anxiety
Tidsramme: Prior to start of intervention
Measured using Geriatric Anxiety Inventory. 20-item scale where participants select either "Agree" or "Disagree" to assess the anxiety symptoms in older adults. The maximum score that could be obtained was 20 points; a high score indicates more anxiety symptoms.
Prior to start of intervention
Symptoms of anxiety
Tidsramme: 3 months post-recruitment
Measured using Geriatric Anxiety Inventory. 20-item scale where participants select either "Agree" or "Disagree" to assess the anxiety symptoms in older adults. The maximum score that could be obtained was 20 points; a high score indicates more anxiety symptoms.
3 months post-recruitment
Symptoms of anxiety
Tidsramme: 6 months post-recruitment
Measured using Geriatric Anxiety Inventory. 20-item scale where participants select either "Agree" or "Disagree" to assess the anxiety symptoms in older adults. The maximum score that could be obtained was 20 points; a high score indicates more anxiety symptoms.
6 months post-recruitment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Life satisfaction
Tidsramme: Prior to start of intervention
Measured using Satisfaction with Life Scale. 5-item scale that included a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree"). The maximum score that could be obtained was 35 points; a high score indicates high level of satisfaction with life.
Prior to start of intervention
Life satisfaction
Tidsramme: 3 months post-recruitment
Measured using Satisfaction with Life Scale. 5-item scale that included a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree"). The maximum score that could be obtained was 35 points; a high score indicates high level of satisfaction with life.
3 months post-recruitment
Life satisfaction
Tidsramme: 6 months post-recruitment
Measured using Satisfaction with Life Scale. 5-item scale that included a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree"). The maximum score that could be obtained was 35 points; a high score indicates high level of satisfaction with life.
6 months post-recruitment
Social connectedness in terms of friendship
Tidsramme: Prior to start of intervention
Measured using Friendship Scale. 6-item where participants had to select an answer out of the five options (1 = "Not at All"; 5 = "Almost Always"). The maximum score that could be obtained was 30 points; a high score indicates high level of social connectedness.
Prior to start of intervention
Social connectedness in terms of friendship
Tidsramme: 3 months post-recruitment
Measured using Friendship Scale. 6-item where participants had to select an answer out of the five options (1 = "Not at All"; 5 = "Almost Always"). The maximum score that could be obtained was 30 points; a high score indicates high level of social connectedness.
3 months post-recruitment
Social connectedness in terms of friendship
Tidsramme: 6 months post-recruitment
Measured using Friendship Scale. 6-item where participants had to select an answer out of the five options (1 = "Not at All"; 5 = "Almost Always"). The maximum score that could be obtained was 30 points; a high score indicates high level of social connectedness.
6 months post-recruitment
Quality of life
Tidsramme: Prior to start of intervention
Measured using World Health Organization Quality of Life-Older Adults module. 13-item scale where participants had to select an answer based on a 5-point rating scale (1 = "Not at All"; 5 = "Very Satisfied"). The maximum score was 65 points, and a high score indicates high quality of life.
Prior to start of intervention
Quality of life
Tidsramme: 3 months post-recruitment
Measured using World Health Organization Quality of Life-Older Adults module. 13-item scale where participants had to select an answer based on a 5-point rating scale (1 = "Not at All"; 5 = "Very Satisfied"). The maximum score was 65 points, and a high score indicates high quality of life.
3 months post-recruitment
Quality of life
Tidsramme: 6 months post-recruitment
Measured using World Health Organization Quality of Life-Older Adults module. 13-item scale where participants had to select an answer based on a 5-point rating scale (1 = "Not at All"; 5 = "Very Satisfied"). The maximum score was 65 points, and a high score indicates high quality of life.
6 months post-recruitment

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cortisol in ng/ml
Tidsramme: Prior to start of intervention
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
Prior to start of intervention
Cortisol in ng/ml
Tidsramme: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment
Annexin-A1 in ng/ml
Tidsramme: Prior to start of intervention
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
Prior to start of intervention
Annexin-A1 in ng/ml
Tidsramme: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment
Interleukin-1-beta in pg/ml
Tidsramme: Prior to start of intervention
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
Prior to start of intervention
Interleukin-1-beta in pg/ml
Tidsramme: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National University, Singapore

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2019

Primær fullføring (Faktiske)

31. januar 2020

Studiet fullført (Faktiske)

31. mars 2020

Datoer for studieregistrering

Først innsendt

1. juni 2021

Først innsendt som oppfylte QC-kriteriene

8. juni 2021

Først lagt ut (Faktiske)

15. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • A17-2003-B

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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