Depressive SymptomsNCT03989284
Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Filipino Senior Citizens
A study testing Community-based depression interventions in people with Depressive Symptoms, run by Tokyo University at 1 site in Philippines.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Community-based depression interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Apr 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Office of the Senior Citizens Affairs
City of Muntinlupa, NCR, 1770
About this study
Official title: Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Community-dwelling Filipino Senior Citizens
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.
Read the detailed description
Study design
The study design was an open (non-blind), non-randomized trial. Senior citizens who got a score suggestive of depression were divided into four groups. The first group (n = 60) only received peer counseling; the second group (n = 60) joined community activities; the third group (n = 60) joined both social engagement and peer counseling, and the last group (n = 60) neither took part in any activities and served as the control group. The investigators analyzed all the participants and assessed the impact of the inventions after three months.
Study area
The study was conducted in Muntinlupa City which is the southernmost city in the National Capital Region, the most populated region in the Philippines. Muntinlupa is classified as highly urbanized city with a poverty incidence of 1.9% in 2012. The city had one of the highest records of senior citizens, which account for 5.63% of its population.
Participants and selection criteria
Participants of this study were community-dwelling seniors in the City of Muntinlupa. Those aged 60 years old and above are regarded as senior citizens in the Philippines. Therefore, the investigators selected Filipino senior citizens who are registered members of the Office of Senior Citizen Affairs (OSCA). Participants were recruited purposively by the primary investigator and trained BHWs through home visits. Each BHW had their own list of senior citizens in their catchment area. The investigators used the list for house-to-house recruitment. The primary investigator and BHWs invited the senior citizens to participate in the study. All participation by seniors was voluntary and participants gave their informed consent prior to participation. Participants must possess a valid senior citizen's identification card to be eligible. The investigators excluded 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.
The investigators included senior citizens who got a score suggestive of depression (GDS score of 5 and above) in this study. The investigators allocated the senior citizens into four groups: (1) peer counseling, (2) social engagement, (3) combination of peer counseling and social engagement, and (4) control. For sample size computation, the investigators used Open Epi version 3.01 and based the following parameters from a meta-analysis of the effects of outreach programs to depressed senior citizens in the community: effect size of 0.77, power of 90%, alpha set at 0.05 (two-sided) and expected dropout rate of 25%. At least 40 senior citizens per group were calculated. Considering the small sample size, the investigators decided to increase the sample size to at least 60 senior citizens per group.
Each senior peer counselor was in charge of two clients. One client was assigned to group A (peer counseling) and another client was assigned to group C (social engagement + peer counseling). The number of participants for social engagement (n = 60) was decided on the basis of location/ space, manageability, and financial resources. There were two batches for the social engagement group. Each batch consisted of 30 participants.
Data collection and study tools
Peer Counselor - Client Meetings - Peer counselors did home visits to their assigned clients for 1-hour every week for three months. The goals of the meetings were to establish a strong working alliance, identify a client-defined problem, encourage behavior change, and facilitate engagement with the community. At the initial visit, the peer counselor asked what the client would like to get out of the meetings in order to establish a client-identified goal that both can work on together. Peer counselors accomplished weekly reports for documentation purposes. Both the peer counselors and clients completed the Working Alliance Inventory-Short Form (WAI-SF) pre- and post-intervention. Clients answered the same set of questionnaires for depression and psychosocial risk factors after study completion. Peer counselors and clients were interviewed to assess their experiences of the intervention. The investigators conducted separate FGDs (5 members per group) with the clients and peer counselors using a semi-structured questionnaire.
Peer Counselor-Health Provider Supervision Meetings - The health providers (psychologist, physician, pharmacist, BHWs) met with the peer counselors once a month for an hour for supervision and collaboration. During meetings, the peer counselors reported on the client's progress and shared impression and insights. The health professionals provided guidance, reinforcement, and constructive feedback to continue skills development of the peer counselors.
Social Engagement Activities - The trained senior volunteers and health providers facilitated the 3-hour weekly social events for three months. The investigators then collected the same set of data for depression and psychosocial risk factors after the intervention. The investigators conducted FGDs consisting of five members per group for both senior participants and trained senior volunteers. An interview guide was used to explore the trained senior volunteers' and senior participants' experience and personal growth after the intervention. The investigators explored their acceptability and motivation to continue the activities. The investigators encouraged the participants to express their views and opinions without confining to the questions being asked.
Data analysis
The investigators carried out pre- and post-intervention comparisons followed by an analysis of semi-structured interview data. The level of significance was set to 0.05 (two-tailed) and statistical analyses were performed using Stata 13.1 (StataCorp, College Station, TX, USA). For semi-structured interviews, the investigators transcribed the recorded notes verbatim, analyzed, and translated the themes and quotes into English. The investigators analyzed with the aid of NVivo using combinations of inductive and analytical approaches. Five investigators were involved in this process and every transcribed interview was analyzed by at least two investigators to test the reliability of the interpretations. Findings were presented as themes that emerged from the analysis of transcripts for peer counseling and social engagement activities.
Ethical considerations
Ethical approval was sought from the Research Ethics Committee of the University of Tokyo and the University of the Philippines Research Ethics Board. The investigators obtained the permission of community-dwelling seniors by giving a letter of consent/permission to conduct research. All participation by seniors was voluntary, and participants gave their informed consent prior to participation. In addition, participants were allowed to withdraw from the study at any time without penalty and had the right to obtain the results of the study if participants so wish. The investigators were aware not to cause emotional harm to the participants by being careful and sensitive during the interviews and activities. Personal biases and opinions did not get in the way of the research.
- Conditions
- Depressive Symptoms
- Being tested
- Community-based depression interventions
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based depression interventionsBehavioural
We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.
| Study group | Role | What they receive |
|---|---|---|
| Peer counseling group | Experimental | Peer counselors performed 1-hour home visits weekly to their assigned clients for three months. Receives: 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. Receives: Behavioral: Community-based depression interventions |
| Combination group | Experimental | Senior citizens in this group underwent both peer counseling and social engagement interventions mentioned above. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 month follow-up
Secondary outcomes (4)
Change from baseline psychological resilience at 3 months
We measured the psychological resilience of the seniors by the Resilience Appraisal Scale (RAS) which contains 12 questions through which seniors indicated the degree of applicability of each statement to them using a five-point Likert scale ("strongly disagree" to "strongly agree"). The total RAS score ranges from 12 to 60, with a higher score indicating higher perceived psychological resilience.
Measured: baseline and 3 month follow-up
Change from baseline perceived social support at 3 months
We assessed perceived social support using the 10-item Duke Social Support Index (DSSI). The possible score ranges from 10 to 30. Higher scores indicated a higher level of perceived social support among participants.
Measured: baseline and 3 month follow-up
Change from baseline loneliness at 3 months
We measured loneliness by the 8-item UCLA Loneliness Scale (ULS-8). The scale employed a 4-point Likert scale with values ranging from "never" to "always" and the total score ranges from 8 to 32. A higher score on this scale indicated more intense feelings of loneliness.
Measured: baseline and 3 month follow-up
Change from baseline working alliance at 3 months
We measured their working alliance using the Working Alliance Inventory-Short Form (WAI-SF). The WAI-SF scores ranged from 12-84, with higher scores indicating a stronger bond and agreement on tasks and goals.
Measured: baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Apr 2018
- Primary completion12 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogie Royce Carandang, Tokyo University
- Investigators
- Masamine Jimba, MD, MPH, PhD, Study chair, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989284
- Sponsor's protocol ID
- SN11641
- Status last verified
- Jun 2019
- First submitted
- 15 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all IPD that underlie results in a publication
Publications
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.
PubMed 32236104
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Community-dwelling Filipino Senior Citizens
- ClinicalTrials.gov ID
- NCT03989284
- Acronym / sponsor ID
- SN11641
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 12 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design
The study design was an open (non-blind), non-randomized trial. Senior citizens who got a score suggestive of depression were divided into four groups. The first group (n = 60) only received peer counseling; the second group (n = 60) joined community activities; the third group (n = 60) joined both social engagement and peer counseling, and the last group (n = 60) neither took part in any activities and served as the control group. The investigators analyzed all the participants and assessed the impact of the inventions after three months.
Study area
The study was conducted in Muntinlupa City which is the southernmost city in the National Capital Region, the most populated region in the Philippines. Muntinlupa is classified as highly urbanized city with a poverty incidence of 1.9% in 2012. The city had one of the highest records of senior citizens, which account for 5.63% of its population.
Participants and selection criteria
Participants of this study were community-dwelling seniors in the City of Muntinlupa. Those aged 60 years old and above are regarded as senior citizens in the Philippines. Therefore, the investigators selected Filipino senior citizens who are registered members of the Office of Senior Citizen Affairs (OSCA). Participants were recruited purposively by the primary investigator and trained BHWs through home visits. Each BHW had their own list of senior citizens in their catchment area. The investigators used the list for house-to-house recruitment. The primary investigator and BHWs invited the senior citizens to participate in the study. All participation by seniors was voluntary and participants gave their informed consent prior to participation. Participants must possess a valid senior citizen's identification card to be eligible. The investigators excluded 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.
The investigators included senior citizens who got a score suggestive of depression (GDS score of 5 and above) in this study. The investigators allocated the senior citizens into four groups: (1) peer counseling, (2) social engagement, (3) combination of peer counseling and social engagement, and (4) control. For sample size computation, the investigators used Open Epi version 3.01 and based the following parameters from a meta-analysis of the effects of outreach programs to depressed senior citizens in the community: effect size of 0.77, power of 90%, alpha set at 0.05 (two-sided) and expected dropout rate of 25%. At least 40 senior citizens per group were calculated. Considering the small sample size, the investigators decided to increase the sample size to at least 60 senior citizens per group.
Each senior peer counselor was in charge of two clients. One client was assigned to group A (peer counseling) and another client was assigned to group C (social engagement + peer counseling). The number of participants for social engagement (n = 60) was decided on the basis of location/ space, manageability, and financial resources. There were two batches for the social engagement group. Each batch consisted of 30 participants.
Data collection and study tools
Peer Counselor - Client Meetings - Peer counselors did home visits to their assigned clients for 1-hour every week for three months. The goals of the meetings were to establish a strong working alliance, identify a client-defined problem, encourage behavior change, and facilitate engagement with the community. At the initial visit, the peer counselor asked what the client would like to get out of the meetings in order to establish a client-identified goal that both can work on together. Peer counselors accomplished weekly reports for documentation purposes. Both the peer counselors and clients completed the Working Alliance Inventory-Short Form (WAI-SF) pre- and post-intervention. Clients answered the same set of questionnaires for depression and psychosocial risk factors after study completion. Peer counselors and clients were interviewed to assess their experiences of the intervention. The investigators conducted separate FGDs (5 members per group) with the clients and peer counselors using a semi-structured questionnaire.
Peer Counselor-Health Provider Supervision Meetings - The health providers (psychologist, physician, pharmacist, BHWs) met with the peer counselors once a month for an hour for supervision and collaboration. During meetings, the peer counselors reported on the client's progress and shared impression and insights. The health professionals provided guidance, reinforcement, and constructive feedback to continue skills development of the peer counselors.
Social Engagement Activities - The trained senior volunteers and health providers facilitated the 3-hour weekly social events for three months. The investigators then collected the same set of data for depression and psychosocial risk factors after the intervention. The investigators conducted FGDs consisting of five members per group for both senior participants and trained senior volunteers. An interview guide was used to explore the trained senior volunteers' and senior participants' experience and personal growth after the intervention. The investigators explored their acceptability and motivation to continue the activities. The investigators encouraged the participants to express their views and opinions without confining to the questions being asked.
Data analysis
The investigators carried out pre- and post-intervention comparisons followed by an analysis of semi-structured interview data. The level of significance was set to 0.05 (two-tailed) and statistical analyses were performed using Stata 13.1 (StataCorp, College Station, TX, USA). For semi-structured interviews, the investigators transcribed the recorded notes verbatim, analyzed, and translated the themes and quotes into English. The investigators analyzed with the aid of NVivo using combinations of inductive and analytical approaches. Five investigators were involved in this process and every transcribed interview was analyzed by at least two investigators to test the reliability of the interpretations. Findings were presented as themes that emerged from the analysis of transcripts for peer counseling and social engagement activities.
Ethical considerations
Ethical approval was sought from the Research Ethics Committee of the University of Tokyo and the University of the Philippines Research Ethics Board. The investigators obtained the permission of community-dwelling seniors by giving a letter of consent/permission to conduct research. All participation by seniors was voluntary, and participants gave their informed consent prior to participation. In addition, participants were allowed to withdraw from the study at any time without penalty and had the right to obtain the results of the study if participants so wish. The investigators were aware not to cause emotional harm to the participants by being careful and sensitive during the interviews and activities. Personal biases and opinions did not get in the way of the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peer counseling group | Experimental | Behavioral: Community-based depression interventionsPeer counselors performed 1-hour home visits weekly to their assigned clients for three months. |
| Social engagement group | Experimental | Behavioral: Community-based depression interventionsSenior citizens joined 3-hour weekly social events held at the OSCA Center for three months. |
| Combination group | Experimental | Behavioral: Community-based depression interventionsSenior citizens in this group underwent both peer counseling and social engagement interventions mentioned above. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based depression interventionsWe conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination. | Behavioural | Combination group, Peer counseling group, Social engagement group |
Primary outcome
Change from baseline depressive symptoms at 3 months
Time frame: baseline and 3 month follow-up
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.
4 secondary outcomes
Change from baseline psychological resilience at 3 months
Time frame: baseline and 3 month follow-up
Change from baseline perceived social support at 3 months
Time frame: baseline and 3 month follow-up
Change from baseline loneliness at 3 months
Time frame: baseline and 3 month follow-up
Change from baseline working alliance at 3 months
Time frame: baseline and 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 32236104Carandang 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.
- Individual participant dataSharing planned: Undecided. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masamine Jimba, MD, MPH, PhD study chair
Tokyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based depression interventions in people with Depressive Symptoms, run by Tokyo University at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depressive symptoms at 3 months (time frame: baseline and 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.