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

June 8, 2021 updated by: 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 117597
        • National University of Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of depression
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life satisfaction
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol in ng/ml
Time Frame: 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
Time Frame: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment
Annexin-A1 in ng/ml
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months post-recruitment
Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes
6 months post-recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • A17-2003-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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