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

8 czerwca 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

21

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

60 lat do 95 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Kontrola
Brak interwencji
Eksperymentalny: 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
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Symptoms of depression
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Life satisfaction
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Cortisol in ng/ml
Ramy czasowe: 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
Ramy czasowe: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment
Annexin-A1 in ng/ml
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National University, Singapore

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 września 2019

Zakończenie podstawowe (Rzeczywisty)

31 stycznia 2020

Ukończenie studiów (Rzeczywisty)

31 marca 2020

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 czerwca 2021

Pierwszy wysłany (Rzeczywisty)

15 czerwca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 czerwca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 czerwca 2021

Ostatnia weryfikacja

1 czerwca 2021

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • A17-2003-B

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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