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

8. června 2021 aktualizováno: 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.

Přehled studie

Typ studie

Intervenční

Zápis (Aktuální)

21

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Singapore, Singapur, 117597
        • National University of Singapore

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let až 95 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Řízení
Žádný zásah
Experimentální: 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
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Symptoms of depression
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Life satisfaction
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cortisol in ng/ml
Časové okno: 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
Časové okno: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment
Annexin-A1 in ng/ml
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. září 2019

Primární dokončení (Aktuální)

31. ledna 2020

Dokončení studie (Aktuální)

31. března 2020

Termíny zápisu do studia

První předloženo

1. června 2021

První předloženo, které splnilo kritéria kontroly kvality

8. června 2021

První zveřejněno (Aktuální)

15. června 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. června 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2021

Naposledy ověřeno

1. června 2021

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • A17-2003-B

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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