Depressive Symptoms Clinical Trial
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.
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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