NCT03989284

Brief Summary

Poor mental health is getting more common in low- and middle-income countries than in high-income countries due to lack of available resources and access to health services. In these countries, there is a large treatment gap for mental health care, with the majority of people with mental disorders receiving no or inadequate care. Depression, for instance, is one of the most common mental disorders and it affects physical health, social activities, and quality of life of senior citizens. Despite being a commonly studied mental disorder, very little is known about depression interventions conducted in low resource settings. Recently, Filipinos' mental illness has been increasing and it affects around 10-15% of children and 17-20% of adults. Their major symptoms include excessive sadness, delusion, confusion, and forgetfulness. Additionally, more Filipino senior citizens are committing suicide due to depression. This is associated with their inability to adapt to rapid social and economic developments. In this study, the investigators aimed to assess the efficacy of 3-month-duration interventions with peer counseling, social engagement, and combined intervention vs. control in improving depressive symptoms among community-dwelling Filipino senior citizens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

June 15, 2019

Last Update Submit

June 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline depressive symptoms at 3 months

    We measured the depression status of the senior citizens by the 15-item Geriatric Depression Scale (GDS). It is specifically developed for use in geriatric patients and contained fewer somatic items. A score of 5 or more is suggestive of depression.

    baseline and 3 month follow-up

Secondary Outcomes (4)

  • Change from baseline psychological resilience at 3 months

    baseline and 3 month follow-up

  • Change from baseline perceived social support at 3 months

    baseline and 3 month follow-up

  • Change from baseline loneliness at 3 months

    baseline and 3 month follow-up

  • Change from baseline working alliance at 3 months

    baseline and 3 month follow-up

Study Arms (4)

Peer counseling group

EXPERIMENTAL

Peer counselors performed 1-hour home visits weekly to their assigned clients for three months.

Behavioral: Community-based depression interventions

Social engagement group

EXPERIMENTAL

Senior citizens joined 3-hour weekly social events held at the OSCA Center for three months.

Behavioral: Community-based depression interventions

Combination group

EXPERIMENTAL

Senior citizens in this group underwent both peer counseling and social engagement interventions mentioned above.

Behavioral: Community-based depression interventions

Control group

NO INTERVENTION

Senior citizens in this group had access to usual or standard care from health and aged care services that were usually available.

Interventions

We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.

Combination groupPeer counseling groupSocial engagement group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Senior citizens aged 60 years old and above with a valid senior citizen's identification card provided by the OSCA.
  • Senior citizens who reported a depression score of 5 or more which indicated a tendency towards depression based on the 15-item Geriatric Depression Scale (GDS-15).

You may not qualify if:

  • Those elderly people in long-term care, with terminal diseases, or with moderate/ severe cognitive impairment and currently suffering from deafness, aphasia or other communication disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Office of the Senior Citizens Affairs

City of Muntinlupa, NCR, 1770, Philippines

Location

Related Publications (1)

  • Carandang RR, Shibanuma A, Kiriya J, Vardeleon KR, Asis E, Murayama H, Jimba M. Effectiveness of peer counseling, social engagement, and combination interventions in improving depressive symptoms of community-dwelling Filipino senior citizens. PLoS One. 2020 Apr 1;15(4):e0230770. doi: 10.1371/journal.pone.0230770. eCollection 2020.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Masamine Jimba, MD, MPH, PhD

    Tokyo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2019

First Posted

June 18, 2019

Study Start

April 1, 2018

Primary Completion

August 12, 2018

Study Completion

September 30, 2018

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations