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.
Condition or disease | Intervention/treatment | Phase |
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Depressive Symptoms | Behavioral: Community-based depression interventions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 270 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Community-dwelling Filipino Senior Citizens |
Actual Study Start Date : | April 1, 2018 |
Actual Primary Completion Date : | August 12, 2018 |
Actual Study Completion Date : | September 30, 2018 |
Arm | Intervention/treatment |
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Experimental: Peer counseling group
Peer counselors performed 1-hour home visits weekly to their assigned clients for three months.
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Behavioral: Community-based depression interventions
We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.
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Experimental: Social engagement group
Senior citizens joined 3-hour weekly social events held at the OSCA Center for three months.
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Behavioral: Community-based depression interventions
We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.
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Experimental: Combination group
Senior citizens in this group underwent both peer counseling and social engagement interventions mentioned above.
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Behavioral: Community-based depression interventions
We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.
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No Intervention: Control group
Senior citizens in this group had access to usual or standard care from health and aged care services that were usually available.
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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Philippines | |
Office of the Senior Citizens Affairs | |
Muntinlupa, NCR, Philippines, 1770 |
Study Chair: | Masamine Jimba, MD, MPH, PhD | Tokyo University |
Tracking Information | |||||
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First Submitted Date ICMJE | June 15, 2019 | ||||
First Posted Date ICMJE | June 18, 2019 | ||||
Last Update Posted Date | June 19, 2019 | ||||
Actual Study Start Date ICMJE | April 1, 2018 | ||||
Actual Primary Completion Date | August 12, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Filipino Senior Citizens | ||||
Official Title ICMJE | Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Community-dwelling Filipino Senior Citizens | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Depressive Symptoms | ||||
Intervention ICMJE | Behavioral: Community-based depression interventions
We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.
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Study Arms ICMJE |
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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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
270 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 30, 2018 | ||||
Actual Primary Completion Date | August 12, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Philippines | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03989284 | ||||
Other Study ID Numbers ICMJE | SN11641 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Rogie Royce Carandang, Tokyo University | ||||
Study Sponsor ICMJE | Tokyo University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Tokyo University | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |