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

Sponsor
National University, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT04927026
Collaborator
(none)
21
1
2
7
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Where-there-is-no-psychiatrist Integrated Personal Therapy (WIPT)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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

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.

No Intervention: Control

No intervention

Outcome Measures

Primary Outcome Measures

  1. Symptoms of depression [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.

  2. Symptoms of depression [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. Symptoms of depression [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.

  4. Symptoms of anxiety [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.

  5. Symptoms of anxiety [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.

  6. Symptoms of anxiety [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.

Secondary Outcome Measures

  1. Life satisfaction [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.

  2. Life satisfaction [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. Life satisfaction [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.

  4. Social connectedness in terms of friendship [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.

  5. Social connectedness in terms of friendship [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.

  6. Social connectedness in terms of friendship [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.

  7. Quality of life [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.

  8. Quality of life [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.

  9. Quality of life [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.

Other Outcome Measures

  1. Cortisol in ng/ml [Prior to start of intervention]

    Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes

  2. Cortisol in ng/ml [6 months post-recruitment]

    Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes

  3. Annexin-A1 in ng/ml [Prior to start of intervention]

    Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes

  4. Annexin-A1 in ng/ml [6 months post-recruitment]

    Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes

  5. Interleukin-1-beta in pg/ml [Prior to start of intervention]

    Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes

  6. Interleukin-1-beta in pg/ml [6 months post-recruitment]

    Stress- and anxiety- related inflammatory outcomes. Collected in lithium heparin tubes

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University of Singapore Singapore Singapore 117597

Sponsors and Collaborators

  • National University, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shefaly Shorey, Principal investigator, National University, Singapore
ClinicalTrials.gov Identifier:
NCT04927026
Other Study ID Numbers:
  • A17-2003-B
First Posted:
Jun 15, 2021
Last Update Posted:
Jun 15, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 15, 2021