"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults
8. Juni 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
21
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
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Singapore, Singapur, 117597
- National University of Singapore
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
60 Jahre bis 95 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Kontrolle
Kein Eingriff
|
|
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Experimental: 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
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Symptoms of depression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Life satisfaction
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cortisol in ng/ml
Zeitfenster: 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
Zeitfenster: 6 months post-recruitment
|
Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
|
6 months post-recruitment
|
|
Annexin-A1 in ng/ml
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 months post-recruitment
|
Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
|
6 months post-recruitment
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. September 2019
Primärer Abschluss (Tatsächlich)
31. Januar 2020
Studienabschluss (Tatsächlich)
31. März 2020
Studienanmeldedaten
Zuerst eingereicht
1. Juni 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2021
Zuerst gepostet (Tatsächlich)
15. Juni 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Juni 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2021
Zuletzt verifiziert
1. Juni 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- A17-2003-B
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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