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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927026
• Other study ID #: A17-2003-B
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2021
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health
• Mindfulness
• Older Adults

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol in ng/ml	Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes	Prior to start of intervention
Other	Cortisol in ng/ml	Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes	6 months post-recruitment
Other	Annexin-A1 in ng/ml	Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes	Prior to start of intervention
Other	Annexin-A1 in ng/ml	Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes	6 months post-recruitment
Other	Interleukin-1-beta in pg/ml	Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes	Prior to start of intervention
Other	Interleukin-1-beta in pg/ml	Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes	6 months post-recruitment
Primary	Symptoms of depression	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
Primary	Symptoms of depression	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
Primary	Symptoms of depression	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
Primary	Symptoms of anxiety	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
Primary	Symptoms of anxiety	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
Primary	Symptoms of anxiety	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
Secondary	Life satisfaction	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
Secondary	Life satisfaction	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
Secondary	Life satisfaction	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
Secondary	Social connectedness in terms of friendship	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
Secondary	Social connectedness in terms of friendship	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
Secondary	Social connectedness in terms of friendship	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
Secondary	Quality of life	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
Secondary	Quality of life	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
Secondary	Quality of life	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