Naturalistic Pilot Study Comparing the Feasibility of Applying a Student Senior Isolation Prevention Partnership vs. Problem-solving Therapy vs. Waitlist Control in Patients Suffering From Late-life Depression During the COVID-19 Pandemic: A Randomized Controlled Trial
Phase: PHASE1
Conditions: Major Depressive Disorder, Late Life Depression
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

 
 
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Naturalistic pilot study comparing the feasibility of applying a Student Senior 
Isolation Prevention Partnership vs. problem-solving therapy 
vs. waitlist control in patients suffering from late-life depression during the 
COVID-19 pandemic: A randomized controlled trial  
  
  
Principal Investigator: Dr. Akshya Vasudev   
Department: Division of Geriatric Psychiatry, Department of Psychiatry   
Address: Associate Professor of Psychiatry and Neuroscience, Western University  
#A2-607, Victoria Hospital, London Health Sciences Centre, 800 Commissioners Road East, 
London, ON  
Email: akshya.vasudev@lhsc.on.ca   
Phone: 519-685-8500 ext. 75504  
  
  
Trial Registration Info:   NCT04887350 
Funding Source: PI start-up funds  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

 
 
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Table of Contents 
Executive Summary ............................................................................................................... 3 
Background ........................................................................................................................... 4 
Objectives.............................................................................................................................. 5 
Hypotheses ............................................................................................................................ 5 
Study Design.......................................................................................................................... 6 
Randomization ...................................................................................................................... 6 
Eligibility Criteria ................................................................................................................... 7 
Inclusion Criteria ............................................................................................................................7 
Exclusion Criteria ...........................................................................................................................7 
Study Outcomes..................................................................................................................... 8 
Feasibility Outcomes ......................................................................................................................8 
Intervention Outcomes ..................................................................................................................8 
Depression – PHQ-9 .............................................................................................................................................. 8 
Anxiety – GAD-7.................................................................................................................................................... 8 
Resilience – Connor-Davidson Resilience Scale (CD-RISC) ................................................................................... 8 
Study Procedures ................................................................................................................... 8 
Recruitment ...................................................................................................................................8 
Screening .......................................................................................................................................9 
Study Interventions........................................................................................................................9 
Study Assessments ....................................................................................................................... 10 
Statistical Considerations ..................................................................................................... 11 
Expected Results and Significance ........................................................................................ 12 
Limitations .......................................................................................................................... 13 
Adverse Events .................................................................................................................... 13 
Study Personnel ................................................................................................................... 14 
References ........................................................................................................................... 15 
 
 
  
  
 

 
 
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Executive Summary   
The COVID-19 pandemic and continued lockdown measures have led to social isolation that is 
likely disproportionately affecting community-dwelling seniors. This social isolation of 
seniors is expected to cause detrimental health effects especially in those who have an ongoing 
or new onset late life depressive episode. The COVID-19 pandemic has also made accessing 
formal psychotherapy services increasingly difficult due to an increased demand 
for these services and a limited number of trained professionals available to deliver 
these interventions. We plan to conduct an open label, pilot, randomized controlled trial (RCT), 
comparing a virtually delivered (telephone) student led mental health 
supportive initiative, Student Senior Isolation Prevention Partnership (SSIPP) 
(n=15) compared to a telephone delivered standard psychotherapy intervention, problem-
solving therapy (PST) (n=15) versus a wait list control (n=15) in community-dwelling 
seniors suffering from late life depression. Participants in this study will be blinded to the 
hypothesis, while those performing data analysis will be blinded to treatment allocation. Both 
SSIPP and PST will be delivered via telephone as a weekly session for 12-weeks. Feasibility 
measures of recruitment, retention and costs will be collected as primary outcome 
measures. Self-rated measures of depression, anxiety, isolation and resilience will 
comprise secondary exploratory outcomes. We anticipate that it will be feasible to conduct an 
RCT of these telephone interventions, SSIPP and PST, in socially isolated community-dwelling 
seniors. Data from this study will be critical to plan a subsequent confirmatory large-scale RCT. 
It could be that telephone delivered medical student led supportive intervention, SSIPP and/or 
a telephone delivered psychotherapy initiative, PST, can be feasibly applied in the current 
pandemic to a high-risk population, isolated seniors suffering from depression.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

 
 
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 Background   
  
The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus 
responsible for the current coronavirus disease 2019 (COVID-19) outbreak, has led to strict 
social distancing and social isolation recommendations from the World Health Organization (1). 
As the elderly are most susceptible to critical illness and fatality due to infection with SARS-CoV-
2, they have also been subjected to the most stringent social isolation guidelines in Canada 
as an attempt to prevent death in this population (1,2). While these public health 
measures are necessary to prevent the spread of SARS-CoV-2 among our vulnerable geriatric 
populations and to protect our over-burdened healthcare systems, social isolation has had a 
detrimental impact on the mental health of this population and has been deemed a mental 
health crisis (1,3). It is well established in the literature that social disconnection and isolation 
places older adults at a particularly great risk of anxiety and depressive symptoms (4). As strict 
lockdown and social distancing measures remain in effect and community-dwelling seniors are 
encouraged to avoid social contact with friends and family, it is crucial that accessible and 
effective mental health interventions be implemented to mitigate the negative consequences 
of social isolation on their mental health.   
  
The Student-Senior Isolation Prevention Partnership (SSIPP) is a national initiative that 
partners medical students with older adults in the community to provide social support and 
connection through regular phone calls. The goal of SSIPP is to reduce rates of 
anxiety, depression, and loneliness, while fostering resilience among seniors in our 
communities. SSIPP was initially launched in March 2020 and has expanded to include ten 
university chapters nationwide with over 500 student volunteers. This student-led initiative has 
been particularly important during the current COVID-19 pandemic as resultant social 
isolation has led to higher self-reported rates of anxiety and depressive symptoms among 
seniors (5). Social isolation and lack of social supports has also led to higher rates of 
loneliness among community-dwelling seniors, demonstrated to be associated with the 
development of numerous physical health conditions, increased all-cause mortality, and 
decreased quality of life in the elderly (5,6). While no qualitative or quantitative data about the 
effectiveness of SSIPP in reducing late-life depression and anxiety currently 
exists, informal feedback from senior community members about their experiences with their 
matched medical students through SSIPP indicates the formation of meaningful relationships 
and social supports, critical issues impacted in the precipitation and maintenance of late life 
depression. This is thought to be particularly beneficial during times of increasing social 
isolation disproportionately affecting senior members of our communities during COVID-19 (5).  
   
Concurrently, other strategies to mitigate the detrimental impact of social isolation on seniors’ 
mental health are formal psychotherapy interventions including problem-solving therapy 
(PST) (7,8). PST has been shown to reduce depression and rates of suicidal ideation, while 
improving disability, in adults aged 60 or older (7,8). PST is a psychotherapeutic 
intervention that teaches community members to identify and clarify problems at hand, set 
clear, achievable goals, brain-storm solutions to the problem, select their preferred solution, 

 
 
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implement this solution, and evaluate the outcomes (9). Unfortunately, in the midst of the 
COVID-19 pandemic, there is limited access to formal psychotherapy due to the public’s 
increased need for these services (5) and the limited number of trained professionals available 
to deliver these services (9). There have been additional difficulties such as finding strategies to 
provision care in light of current public health restrictions (10), and an increased uptake in the 
use of telehealth services to provide mental health support (11).   
   
Due to this increased need for social support resulting from the COVID-19 pandemic, increasing 
social isolation among seniors, and the increased risk of deteriorating physical and mental 
health that this imposes (5), it is crucial to find an easily accessible and effective intervention 
available to these senior members of our community to mitigate the detrimental impacts 
of social isolation. A student-led initiative, such as SSIPP, is a program that could fill this need 
within our community to improve the mental health of community-dwelling seniors and 
prevent the negative downstream health effects that result from social isolation. SSIPP is also 
delivered via telephone, which allows for public safety during COVID-19, and can be 
delivered without the presence of highly trained health professionals. These factors make this 
program more accessible than formal psychotherapy to seniors in our community.   
  
The aim of this study is to assess the feasibility of delivering SSIPP in London, Canada, as 
compared to an active control, PST, as well as a wait list control. Such a study would also allow 
to collect effect size estimates on the efficacy of SSIPP on self-rated depression, anxiety, 
isolation and resilience among community-dwelling seniors.  Data from this study will help 
inform the design of a future large, multi-center RCT which may help determine if SSIPP could 
be as effective as the structured psychotherapy PST at reducing self-rated depression, anxiety, 
and isolation, while improving self-rated resilience among community-dwelling seniors. 
  
Objectives   
Objective 1: To determine if it is feasible to conduct an RCT of telephone SSIPP in comparison 
to PST delivered to community-dwelling seniors during the current constraints imposed by 
COVID-19 and the need for telephone delivery of these services.   
Objective 2: To determine the extent of change in self-rated depression, anxiety, isolation and 
resilience measures in a telephone delivered SSIPP as compared to telephone delivered PST and 
wait list control among community dwelling seniors.  
  
Hypotheses   
Hypothesis 1: It will be feasible to conduct an RCT of telephone SSIPP in comparison 
to telephone PST and a wait list control, under the current constraints imposed by COVID-19 
and the need for telephone delivery of these services.   
Hypothesis 2: It will be possible to collect effect size estimates of SSIPP compared to PST and a 
wait list control on symptoms of depression, anxiety, isolation and resilience in community 
dwelling seniors.   
 

 
 
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Study Design   
This study will be open label, randomized, controlled trial comparing 12-week telephone 
delivered SSIPP and PST in a total of 45 participants, randomized in a 1:1:1 ratio to one of three 
groups. The three study groups that participants could be randomized to, include SSIPP, PST, 
or a waitlist control (WLC). The WLC participants will self-select participation in either SSIPP or 
PST at the end of the 12-week waiting period. They will not complete study 
assessments following week 12. This study will plan to enroll n=45 with 15 participants 
randomized to each of the three groups. Participants will be asked to complete brief surveys, 
with online in REDCap or over the phone with a Research Assistant at weeks 0 and 12 of the 
study. REDCap will be used to achieve randomization and its concealment. Statistical analysts 
will be blinded to group allocation during data analysis.    
  
Randomization   
Participants will be randomized after they have: 
1. Provided verbal informed consent. 
2. Signed and returned their letter of information (LOI) by mail to the Division of Geriatric 
Psychiatry (in a return envelope provided) or signed the electronic LOI in REDCap. 
3. The PI has confirmed eligibility.   

 
 
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Due to the COVID-19 pandemic, and the remote nature of this study, written paper consent 
cannot be witnessed by a study team member. Verbal consent will be obtained and 
documented for all participants. A randomization list will be generated using 
sealedenvelope.com and uploaded into REDCap. Randomization will be generated in random 
block sizes of 3, 6, and 9. REDCap will be used to perform randomization and allocation 
concealment. REDCap is widely used by health researchers worldwide to reduce errors in data 
entry and study management while improving confidentiality. All study participants will be 
blinded to the study hypotheses to prevent expectation bias.  The study coordinator, Emily 
Ionson, will randomize participants using REDCap and inform the participant as well as their 
assigned PST or SSIPP counsellor as applicable of their intervention allocation. Participants will 
be assigned a screening code at time of expressing interest in the study e.g. SC001, SC002, 
SC003 etc. Upon confirmation of eligibility by the PI participants will be assigned a study code 
e.g. TEL001, TEL002, TEL003. Only the study coordinator will have access to the randomization 
list in REDCap. 
 
 
Eligibility Criteria   
Inclusion Criteria   
1. Community-dwelling senior 65 years of age or older.  
2. Meeting criteria of suffering from an episode of major depression, mild to 
moderate, as assessed by an experienced psychiatrist (DSM 296.21, 296.22, 296.31, 
296.32), with the following applicable specifiers including anxious distress, mixed 
features, melancholic features, atypical features and seasonal pattern  
3. Willing to receive services via telephone.   
4. Have sufficient hearing to converse via telephone.  
5. Have an adequate understanding of written and spoken English.  
6. Answer yes to the question “do you perceive that you are either lonely or 
isolated?” 
  
Exclusion Criteria   
1. Pre-existing dementia or other neurodegenerative disorder as confirmed by a 
Montreal Cognitive Assessment (MoCA) score, telephone version, 17 or below  
2. History of schizophrenia   
3. History of bipolar disorder  
4. History of substance use disorder   
5. History of personality disorder as per previous clinical documentation   
6. History of suicide attempts or threats as per previous clinical documentation or 
endorsement of any of the questions from item 2-6 of the Columbia- Suicide 
Severity Rating Scale. 
  

 
 
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Study Outcomes   
Feasibility Outcomes   
The following feasibility outcomes will be measured: (1) rate of participant recruitment, (2) rate 
of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected 
costs. These measures will be collected throughout the study and totaled at the end of the 
study.   
  
Intervention Outcomes   
Depression – PHQ-9   
The Patient Health Questionnaire (PHQ-9) is a 9-item, self-rated measure of depression which 
has been validated for screening a major depressive episode in adults. Total scores 
indicate level of depression: 0–4, no depression; 5–9, mild depression; 10–14, moderate 
depression; 15–19, moderately severe depression; 20–27, severe depression (12, 13).  
  
 
 
Anxiety – GAD-7   
The Generalized Anxiety Disorder 7-item scale (each scored 0–3) is a self-rated measure of 
anxiety that has been validated for the diagnosis of Generalized Anxiety Disorder in the adult 
population. The scale is scored from 0 to 21. Higher scores indicate greater anxiety symptoms 
(5–9, mild anxiety; 10–14, moderate anxiety; 15–21 severe anxiety) (14).  
 
Isolation – Lubben Social Network Scale-6 –LSNS6 
The Lubben Social Network Scale 6 is a self-rated assessment scale comprised of 6 items, each 
rated on a 6-point likert scale (0 = none, 1 = one, 2 = two, 3 = three or four, 4 = five thru eight, 5 
= nine or more). Higher scores indicate a lower level of isolation. The LSNS6 has demonstrated 
high levels of internal consistency (15). 
  
Resilience – Connor-Davidson Resilience Scale (CD-RISC)   
The Connor-Davidson Resilience Scale (CD-RISC) is a self-rated 
assessment scale comprised of 10 items, each rated on a 5-point Likert scale (0 = not true at all 
to 4 = true nearly all the time). Higher scores reflect greater resilience, indicating one’s ability 
to cope with stressful situations. The scale has demonstrated strong reliability and validity in a 
variety of populations (16).   
 
Study Procedures   
Recruitment   
Participants will include community-dwelling seniors (n=45) recruited from the Division of 
Geriatric Psychiatry at Parkwood Institute and from the Geriatric Mental Health Program at 
London Health Sciences Center, both located in London, Ontario. Participants to these two 
programs receive referrals from family doctors serving the city of London and 

 
 
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surrounding Middlesex County. The study will recruit via existing relationships and 
referrals established by the study PI and co-investigator. The PI and co-investigator will make 
initial contact with potential participants, providing two copies of the letter of information (LOI) 
with a return postage envelope to return one copy of the LOI by mail to the Division of Geriatric 
Psychiatry. The other copy of the LOI will be retained by patients for their records. 
 
 
 
 
 
 
 
 
 
 
Screening   
After receiving the LOI, potential participants will be given a minimum of 24 hours to review 
this information. Potential participants will then receive a phone call from a trained Research 
Assistant (RA) to further explain the study and answer questions participants may have prior to 
enrolment. During this phone call, the RA will obtain verbal consent for those willing 
to participate, and document this. If participants are willing to electronically sign the LOI and 
submit via REDCap they will immediately be provided with the contact information form 
requesting contact information including email address and phone number. Alternatively, 
potential participants can elect to sign the paper copy of the LOI provided to them at initial 
contact with the study PI or co-investigator, and return by mail with the return envelope 
included.   
Prior to calling potential participants to review the LOI and obtain verbal consent, a trained RA 
will access the participant’s chart, either paper or electronic charts, to perform pre-screening 
for eligibility. The RA will contact the potential participant’s psychiatrist to clarify any 
information that is unavailable or unclear after reviewing the patient’s chart. Pre-screening 
eligibility will be documented by the RA. Once completed pre-screening forms and signed LOI’s 
are reviewed by the PI or co-investigator, patients will be enrolled in the study.   
Study Interventions   
Both SSIPP and PST will be delivered via telephone. Telephone PST will be delivered by a trained 
healthcare professional from the Division of Geriatric Psychiatry and/or the Geriatric Mental 
Health Program which may include a psychologist, a social worker, a nurse, or an occupational 
therapist. These health professionals will receive a one-hour review training course delivered by 
a trainer within the Division of Geriatric Psychiatry prior to delivering PST to participants. 
PST will be delivered to study participants once a week for a 30–60-minute session over a 12-
week period. PST therapists will administer the PHQ-9 during each of the 12 PST sessions as 
part of the standard PST program. SSIPP is a pre-existing initiative at the Schulich School of 
Medicine and Dentistry in London, Ontario where medical students are matched with a 

 
 
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community-dwelling senior to provide social support via weekly phone calls. This intervention 
will be delivered to participants by a medical student in compliance with SSIPP’s pre-
existing protocol. Phone calls will be made by medical students once a week on a schedule 
negotiated by the medical student and matched participant. Medical students will be required 
to complete a weekly call log to ensure completion of these calls, as per SSIPP protocol. Medical 
students will receive a one-hour training session, provided by SSIPP according to their standard 
procedure, prior to beginning calls with their matched senior participant. Both PST and SSIPP 
counsellors will take attendance for each planned session and notate any negative or positive 
comments provided by participants about the program. Any suspected adverse events (AE) will 
be reported by the counsellors to the PI within 24 hours.   
  
 
 
 
 
 
 
 
Study Assessments   
Assessment  
Date of Administration  
Name of Assessment  
Variables  
Screening  
Week 0  
Week 12  
Informed consent  
Consent  
X  
 
 
Contact information 
form  
Name, phone number, e-mail 
address, mailing address  
X  
 
 
Inclusion/exclusion 
Eligibility  
X  
 
 
Telephone MoCA 
Objective neurocognitive 
impairment 
X 
C-SRSS 
Suicidal Ideation or Intent 
X 
X 
Demographics 
questionnaire  
Age, gender, past year substance use, 
religious and spiritual affiliation, 
frequency of religious practice, previous 
history of mental health disorders, 
physical health status using CIRS-G 
 
X  
 
GAD-7  
Anxiety  
 
X  
X  
PHQ-9  
Depression  
 
X  
X  
LSNS6 
Isolation 
X 
X 
CD-RISC-10  
Resilience  
 
X  
X  
Medication Assessment   
 
 X 
X  
 Abbreviations: Generalized Anxiety Disorder-7 scale (GAD-7), Patient Health Questionnaire-9 scale (PHQ-9), Lubben Social Network Scale 6 
(LSNS6) and Connor-Davidson Resilience Scale-10 (CD-RISC-10).  
  
Once enrolled, demographic data including age, gender,  substance use history, religious and 
spiritual affiliation, frequency of religious practice, and previous history of mental health 
disorders will be collected. The telephone MoCA will also be administered by a trained research 
assistant at this time to ensure potential participants have a minimum score of 18. This tool is a 
valid measure to screen for mild cognitive impairment in a variety of patient populations (25). 

 
 
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As this is a naturalistic study, psychiatric medications will be assessed at week 0 and week 12 
through participants’ psychiatrist/s at the Division of Geriatric Psychiatry and /or the Geriatric 
Mental Health Program to assess for medication changes made during the 12-week study 
period. Physical health status of patients will be screened for using the Cumulative Illness 
Rating Scale for Geriatric patients (CIRS-G). This scale has been validated to compute ratings of 
chronic illness burden in medically and psychiatrically impaired elderly subjects (21). Finally, the 
Columbia Suicide Severity Rating Scale (C-SRSS) will be used to screen patients for suicidal 
ideation or intent prior to enrolment. This scale is a reliable and valid measure to screen for 
suicidal ideation, behaviour, and intent (24).  
  
The following well validated, self-rated scales will be administered to participants. Completion 
of the self-rated scales can be completed online (for participants who are comfortable with this 
format and have access to a computer) or by a trained research assistant over the phone with 
the participant (for participants who are not comfortable with the use of computer-based 
technology). The RA will ask the patient the scale questions verbally over the phone, and 
document all participant responses on a paper form. The paper copy of participant responses 
will be stored in a locked cabinet, until responses can be entered into the REDCap database. 
The Generalized Anxiety Disorder-7 scale (GAD-7) will be used to screen for anxiety and the 
Patient Health Questionnaire-9 scale (PHQ-9) will be used to screen for depression, with no cut-
off scores necessary as participants will have received a diagnosis by a psychiatrist. The Lubben 
Social Network Scale 6 (LSNS6) will be used to assess isolation (15). The Connor-Davidson 
Resilience Scale-10 (CD-RISC-10) will be used to screen for resilience (U.S.A. general population 
mean =32.1 and standard deviation = 5.8). Data from the electronic surveys and paper surveys 
completed over the telephone with participants will be entered to REDCap by a trained 
Research Assistant.   
  
All self-rated scales will be administered at week 0 before beginning interventions, and at week 
12, following delivery of the last intervention session. Although PHQ-9's will be collected during 
each PST session only the PHQ-9 collected from session 1 and session 12 will be utilized as 
outcome data. Participants in SSIPP will only complete pre and post intervention PHQ-9's. If a 
participant drops out for any reason, the reason for drop out will be collected by a telephone 
call performed by an RA.  
  
Statistical Considerations   
Primary outcome measures will be calculated using rates, percentages and costs. For 
exploratory purposes, the secondary outcome measures will be subject to the following 
analyses. A Multivariate Analysis of Variance (MANOVA) will be conducted to detect differences 
between the two interventions, i.e. SSIPP and PST as the independent variables and scores on 
GAD-7, PHQ-9, and CD-RISC-10 scale as the dependent variables. Multivariate F value (Wilks' λ 
or Hotelling's trace or Pillai's trace) will be used with a statistical significance set at p < 
0.05. Demographic measures will be described using either calculations of means or percentage 
as required. As there is no consensus or current evidence recommending an appropriate 
sample size for feasibility studies, it is advised that feasibility study samples sizes not be 

 
 
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attempted a priori (17).  Pilot studies investigating the comparable psychotherapies cognitive 
behavioural therapy (CBT) and mindfulness-based cognitive therapy (MCBT) were able to 
demonstrate reductions in self-reported anxiety and depression with a sample size of n=52 and 
n=30, respectively (22,23). Given these effect sizes, the desired sample size is n=45. Attrition 
and retention rates will be calculated as feasibility measures as part of this pilot study to help 
inform required sample size for a future large, multi-center RCT. 
  
IBM SPSS ® (v26) will be used for the conduction of data analysis (18). Contingent on final 
sample size, either the Kolmogorov-Smirnov or the Shapiro-Wilk test will be used to assess 
normality of the data. The Expectation-Maximization (EM) algorithm will be used to account for 
missing data (19, 20). Analysis will first be carried out using an Intent to Treat (ITT) approach, 
followed by per protocol (PP) analyses for the participants who completed the study only. The 
differences in anxiety, depression, and resiliency outcomes between the groups at week 0 and 
week 12 will be analyzed using a repeated MANOVA test, in both ITT and PP analysis groups.  
  
Expected Results and Significance   
We expect this pilot feasibility study will demonstrate that it is feasible to conduct an RCT of 
telephone-delivered PST versus SSIPP for community-dwelling seniors in the London area. It will 
also be feasible to deliver both of these services over the telephone. SSIPP is a current initiative 
at the Schulich School of Medicine and Dentistry that is currently delivered by medical students 
to community-dwelling seniors over the telephone. Delivering PST over the telephone will 
reduce participants’ and healthcare providers’ risk of exposure to COVID-19. Based on previous 
statements from community-dwelling seniors currently enrolled in SSIPP indicating their 
positive experience with the initiative, we expect that SSIPP will be as effective as the formal 
psychotherapy intervention PST for improving self-rated depression, anxiety, and resiliency. 
Overall, this study is necessary in light of the COVID-19 pandemic and continuing lockdown 
measures that further isolate community-dwelling seniors and limit access to formal 
psychotherapy interventions. Social isolation has disproportionately affected the mental health 
of seniors contributing to a detrimental impact on their quality of life and physical health, while 
increasing their mortality even prior to the COVID-19 pandemic and subsequent public health 
measures that placed them at an increased risk. The results from this study will be crucial for 
directing future initiatives with the goal of reducing social isolation and its sequelae among 
community-dwelling seniors. This study will inform if it is feasible to conduct a future RCT that 
may be able to determine if student-led initiatives, such as SSIPP, are as effective as the 
structured psychotherapy intervention PST. The results from this study may be used to direct a 
future RCT that may determine if student-led initiatives have the potential to fill the need for 
geriatric mental health supports resulting from the limited accessibility of and the increased 
demand for formal psychotherapy interventions as a result of the COVID-19 pandemic.   
  

 
 
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Limitations   
One potential limitation of this study is that recruitment will be taking place from the Division 
of Geriatric Psychiatry, Parkwood and the Geriatric Mental Health Program at LHSC. This could 
lead to a disproportionately high representation of seniors with pre-existing mild to moderate 
depression, rather than those suffering from depressive and anxiety symptoms not meeting 
criteria for a major depressive episode. This could limit generalisability of our findings to the 
community. PST is currently used as an adjunctive therapy to pharmacotherapy in managing 
depression, anxiety, and other psychiatric concerns in seniors. As this is a naturalistic study, 
our interventions (ie. PST and SSIPP) will be implemented as adjuncts to current therapy 
participants are receiving. Differences in pre-existing extent of anxiety or depression, and 
differences in treatment modalities that participants are receiving prior to the start of the trial 
period will be mitigated by the randomization process. We will also collect data at the end of 
the 12-week study period to assess for psychiatric medication changes made by participants’ 
psychiatrists during the study period. 
  
Another potential limitation of our study is the delivery of email based LOIs, eligibility forms, 
demographic forms, and self-rated scales. Online forms may be difficult for our study 
population to navigate independently, or to access if they do not own a computer. This 
limitation will be overcome by offering participants the opportunity to complete these forms 
over the phone with a trained RA who will record and document their responses. Participants 
may feel more comfortable completing surveys by this method, leading to a better rate of 
retention. Our study has also included a low number of self-rated scales and brief 
questionnaires to also assist with participant retention.   
  
Adverse Events   
During the enrollment process, participants will be provided with contact information for the 
study PI and will be instructed to call the PI at 519-685-8500 ext. 75504  if they experience 
deterioration in their mental health or suicidality. Participants will be informed that this 
voicemail will be checked regularly during business hours. Participants will also be informed 
that they can reach the study PI by email at akshya.vasudev@lhsc.on.ca between the hours of 
7am and 4pm. If participants experience a deterioration in their mental health or suicidality, at 
any time, they will also be provided with the phone number for the Canadian Mental Health 
Association crisis line, which is available 24/7, and be encouraged to visit their local Emergency 
Department for immediate support, at any time, if requiredParticipants will only be recruited to 
this study if they are capable and consenting. Study staff, PST counsellors, and SSIPP counsellors 
will report any suspected AE to the PI within 24 hours.  
  
 
 
 
 
 

 
 
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Study Personnel   
Name  
Role in Study  
E-mail  
Akshya Vasudev  
Principal Investigator  
akshya.vasudev@lhsc.on.ca  
Lisa VanBussel 
Co-Investigator 
lisa.vanbussel@sjhc.london.on.ca 
Emily Ionson  
Research Coordinator  
emily.ionson@lhsc.on.ca  
Sarah Meulendyks   
Student Research Assistant  
smeulendyks2024@meds.uwo.ca  
Taranah Adli  
Student Research Assistant   
tadli2024@meds.uwo.ca  
Jia Zhang   
Student Research Assistant  
jzhang2023@meds.uwo.ca  
Juanni Liu   
Clinical Trials Management 
Student  
jliu788@uwo.ca 
Katy DAngelo 
PST therapist 
Katy.DAngelo@lhsc.on.ca 
Susan Macdonald 
PST therapist 
Susan.Macdonald@sjhc.london.on.ca 
Adriana Barel 
PST therapist 
Adriana.Barel@sjhc.london.on.ca 
Patrick Flemming 
PST therapist 
Patrick.Fleming@lhsc.on.ca 
Lisa Joworoski 
PST therapist 
Lisa.Joworski@lhsc.on.ca 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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