Clinical trial NCT04927026: "Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults
Official title: "Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Mental Health
Mindfulness
Solution-focused Brief Therapy
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 21
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms of depression
timeFrame: Prior to start of intervention
measure: Symptoms of depression
timeFrame: 3 months post-recruitment
measure: Symptoms of depression
timeFrame: 6 months post-recruitment
measure: Symptoms of anxiety
timeFrame: Prior to start of intervention
measure: Symptoms of anxiety
timeFrame: 3 months post-recruitment
measure: Symptoms of anxiety
timeFrame: 6 months post-recruitment
Secondary outcomes:
measure: Life satisfaction
timeFrame: Prior to start of intervention
measure: Life satisfaction
timeFrame: 3 months post-recruitment
measure: Life satisfaction
timeFrame: 6 months post-recruitment
measure: Social connectedness in terms of friendship
timeFrame: Prior to start of intervention
measure: Social connectedness in terms of friendship
timeFrame: 3 months post-recruitment
measure: Social connectedness in terms of friendship
timeFrame: 6 months post-recruitment
measure: Quality of life
timeFrame: Prior to start of intervention
measure: Quality of life
timeFrame: 3 months post-recruitment
measure: Quality of life
timeFrame: 6 months post-recruitment
Other outcomes:
measure: Cortisol in ng/ml
timeFrame: Prior to start of intervention
measure: Cortisol in ng/ml
timeFrame: 6 months post-recruitment
measure: Annexin-A1 in ng/ml
timeFrame: Prior to start of intervention
measure: Annexin-A1 in ng/ml
timeFrame: 6 months post-recruitment
measure: Interleukin-1-beta in pg/ml
timeFrame: Prior to start of intervention
measure: Interleukin-1-beta in pg/ml
timeFrame: 6 months post-recruitment
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
References: