The BEACON Study: Protocol for a Pilot Randomized Controlled Trial of Smartphone-assisted Problem Solving Therapy in Men Who Present With Intentional Self-harm to Emergency Departments in Ontario
Phase: NA
Conditions: Intentional Self-Harm, Suicide
Sponsor: University of Ottawa

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Study Protocol 
 
Protocol Name: 
The BEACON Study: Protocol for a pilot randomized controlled trial 
of smartphone-assisted problem solving therapy in men who present 
with intentional self-harm to Emergency Departments in Ontario 
Clinical Trial Type: 
Non-Regulated Investigational Clinical Trial 
REB Reference Number 
CTO-0790 
Funder 
Ontario SPOR Support Unit (OSSU) 
Sponsor 
Ottawa Hospital Research Institute (OHRI) 
Principal Investigator 
Dr. Simon Hatcher 
Co-Principal 
Investigator 
Dr. Marnin Heisel  
  
 
 

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PROTOCOL SIGNATURE PAGE 
 
The clinical study as detailed within this research protocol (Version 1, dated 24-Feb-2017 
or any subsequent amendments will be conducted in accordance with the Tri-Council 
Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and Good 
Clinical Practice (GCP), an international ethical and scientific quality standard for 
designing, conducting, recording and reporting trials that involve the participation of 
human subjects. 
 
Principal Investigator Name: Dr. Simon Hatcher 
Co-Principal Investigator Name: Dr. Marnin Heisel 
 
Coordinating Site:            Ottawa Hospital Research Institute 
Contact details:  
Tel No: (613) 737-8899, ext. 81209 
 
 
 
Email: shatcher@toh.ca  
 
 
 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 
 
Site Co- Investigator Name: 
Site Name: [XXXXXXXXXXXXXXXXXX] 
Contact details:  
Tel No: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Email: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Fax: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 
Site Co- Investigator Name: 
Site Name: [XXXXXXXXXXXXXXXXXX] 
Contact details:  
Tel No: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Email: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Fax: [XXXXXXXXXXXXXXXXXX 
 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 

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World Health Organization Trial Registration Data Set Items 
 
DATA CATEGORY 
INFORMATION 
Primary registry and trial identifying number ClinicalTrials.gov 
 NCT03473535 
Date of registration in primary registry 
22-Mar-2018 
Source(s) of monetary or material support 
Ontario SPOR Support Unit (OSSU) 
Primary sponsor 
Ottawa Hospital Research Institute 
Contact for public queries 
Dr. Simon Hatcher, MD 
Ottawa Hospital Research Institute, Ottawa, ON  
Tel: (613) 737-8899, ext. 81209 
Email: shatcher@toh.ca  
Contact for scientific queries 
Dr. Simon Hatcher, MD 
Ottawa Hospital Research Institute, Ottawa, ON  
Tel: (613) 737-8899, ext. 81209 
Email: shatcher@toh.ca 
Public title 
The BEACON Study 
Scientific title 
The BEACON Study: Protocol for a pilot 
randomized controlled trial of smartphone-assisted 
problem solving therapy in men who present with 
intentional self-harm to Emergency Departments in 
Ontario 
Countries of recruitment 
Canada 
Health condition(s) or problem(s) studied 
Intentional Self-harm 
Intervention(s) 
Intervention: smartphone-assisted PST 
 
Key inclusion and exclusion criteria 
Ages eligible for study: ≥18 years 
Genders eligible for study: Men and Trans-Men 
Accepts healthy volunteers: No 
Inclusion criteria: adult patient (≥ 18 years); patient 
identifies as male, patient presents to Emergency 
Department for an index episode of intentional 
self-harm at one of the Emergency Departments 
randomized to receive the study intervention.  
 

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DATA CATEGORY 
INFORMATION 
Exclusion criteria: patient presented to an 
Emergency Department randomized to receive the 
study intervention for a reason other than 
intentional self-harm; patient does not have a valid 
OHIP card; patient is unable to read and 
understand English, French or is unable to read or 
understand Oji Cree; patient is unable and/or 
unwilling to provide informed consent; is 
unwilling to return to hospital for follow-up 
appointments.; patient is unlikely to commit to a 
one year study. 
Study type 
Randomized controlled trial 
Allocation: 2:1 
Intervention model: parallel group 
Masking: none 
Primary purpose: prevention 
Target sample size 
100 
Primary outcome(s) 
Beck Scale for Suicide Ideation (BSS) 
Key secondary outcomes 
Masculinity (CMNI); Depression (PHQ-9); 
Anxiety (GAD-7); PTSD (PC-PTSD); Health-
related quality of life (EQ-5D-5L); Meaning in 
Life (EMIL); Social Supports (MSPSS); Alcohol 
Misuse (AUDIT-C & AUDIT), Substance Misuse 
(DAST-10); Health Costs (TiC-P); Problem-
Solving Skills (SPSI-R:S). 
 
 
 

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Table of Contents 
1. 
FUNDING........................................................................................................................ 10 
2. 
ROLES AND RESPONSIBILITIES ............................................................................... 10 
2.1. Contributorship ............................................................................................................. 10 
2.1.1. 
Author’s Contributions ...................................................................................... 10 
2.2. Sponsor contact information ......................................................................................... 11 
2.3. Committees ................................................................................................................... 11 
2.3.1. 
Principal Investigator and co-Principal Investigator: ........................................ 11 
2.3.2. 
Steering committee (refer to title page for members) ........................................ 11 
2.3.3. 
Trial Management Committee (TMC) ............................................................... 11 
2.3.4. 
Data and Safety Monitoring Committee (DSMC) ............................................. 12 
2.3.5. 
Lead Investigators .............................................................................................. 12 
3. 
INTRODUCTION ........................................................................................................... 12 
3.1. Background and Rationale ............................................................................................ 12 
3.1.1. 
Why is Intentional Self-Harm an Important Problem? ...................................... 12 
Definition of Self-Harm ....................................................................................................... 12 
Presenting to Hospitals with Self-Harm is Common ........................................................... 13 
Self-Harm is Related to Suicide, Premature Mortality and High Use of Services .............. 13 
Why Focus on Men? ............................................................................................................ 14 
Summary of Relevant Studies of Psychological Therapies After Self-Harm ...................... 14 
Summary of Relevant Studies of Blended Therapy in the Treatment of Self-Harm ........... 15 
Assessment, Care and Discharge from the Emergency Department ................................... 16 
3.2. Objectives and Hypotheses ........................................................................................... 17 
3.2.1. 
Primary Objective & Hypotheses ...................................................................... 17 
3.2.2. 
Secondary Objectives & Hypotheses ................................................................. 17 
3.3. Study Design ................................................................................................................. 18 
4. 
METHODS ...................................................................................................................... 18 
4.1. Participants, Interventions and Outcomes .................................................................... 18 
4.1.1. 
Study Setting ...................................................................................................... 18 
4.1.2. 
Eligibility Criteria .............................................................................................. 19 
4.1.3. 
Interventions ...................................................................................................... 19 
4.1.4. 
Outcome Measures............................................................................................. 21 
4.1.5. 
Sample Size ........................................................................................................ 28 
4.1.6. 
Recruitment ........................................................................................................ 28 
4.2. Assignment of Interventions ......................................................................................... 29 
4.2.1. 
Allocation to Intervention .................................................................................. 29 

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4.2.2. 
Blinding.............................................................................................................. 29 
4.2.3. 
Participant Timeline ........................................................................................... 29 
4.3. Data Collection, Management and Analysis ................................................................. 30 
4.3.1. 
Data Collection .................................................................................................. 30 
Data Collection Methods ............................................................................................. 30 
Retention ...................................................................................................................... 31 
4.3.2. 
Data Management .............................................................................................. 32 
4.3.3. 
Statistical Methods ............................................................................................. 33 
Missing Data ................................................................................................................ 33 
4.4. Monitoring .................................................................................................................... 34 
4.4.1. 
Data Monitoring ................................................................................................. 34 
4.4.2. 
Harms ................................................................................................................. 34 
4.4.3. 
Study Monitoring ............................................................................................... 35 
5. 
ETHICS AND DISSEMINATION.................................................................................. 37 
5.1. Research Ethics Approval ............................................................................................. 37 
5.2. Protocol Amendments ................................................................................................... 38 
5.3. Consent ......................................................................................................................... 38 
5.3.1. 
Informed Consent............................................................................................... 38 
5.3.2. 
Ancillary Studies ................................................................................................ 38 
5.4. Confidentiality .............................................................................................................. 38 
5.5. Declaration of Interests ................................................................................................. 39 
5.6. Access to Data .............................................................................................................. 39 
5.7. Ancillary and Post-Trial Care ....................................................................................... 40 
5.8. Dissemination Policy .................................................................................................... 40 
5.8.1. 
Trial Results ....................................................................................................... 40 
Data Analysis and Release of Results .......................................................................... 40 
Review Process ............................................................................................................ 40 
Primary Outcome Publications .................................................................................... 40 
Other Study Papers, Abstracts and Presentations ........................................................ 41 
Close-Out Procedures .................................................................................................. 41 
Reporting of Study Results .......................................................................................... 41 
5.8.2. 
Authorship.......................................................................................................... 41 
Qualification for Authorship ........................................................................................ 41 
Author’s Contribution .................................................................................................. 42 
Acknowledgments........................................................................................................ 42 
5.8.3. 
Reproducible Research ...................................................................................... 42 

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6. 
APPENDICES ................................................................................................................. 43 
6.1. Appendix A – Completion Time Required for All Outcome Measures included in 
Study .................................................................................................................................... 43 
6.2. Appendix B- List of Study Sites ................................................................................... 44 
6.3. Appendix C - Informed Consent Materials ................... Error! Bookmark not defined. 
6.4. Appendix D - Protocol for a cluster randomized controlled trial of a service to deliver 
smartphone-assisted problem solving therapy compared to usual care in men who present 
with intentional self-harm to Emergency Departments in Ontario ..... Error! Bookmark not 
defined. 
7. 
REFERENCES ................................................................................................................ 45 

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List of Figures 
 
Figure 1 
BEACON Suicide Prevention Smartphone Application Navigation  
  20 
 
Figure 2 
BEACON Suicide Prevention Smartphone Application Map 
 
  21 
 
Figure 3 
Participant Time Line  
 
 
 
 
 
 
  32 
 
List of Tables 
 
Table 1 
Participant Eligibility Criteria  
 
 
 
 
              18 
 
Table 2 
MSPSS Reliability Statistics  
 
 
 
 
              24 
 
Table 3 
Internal Consistency Statistics for CMNI Subscales   
 
              27 
 
Table 4 
Correlations Between SPSI Measures and Measures                                       29 
of Stress and Psychological Symptomatology in a  
College Student Sample and a Community Resident  
Sample 
 
Table 5 
Outcome Variables   
 
 
 
 
 
              33 
 
Table 6 
Process Evaluation 
 
 
 
 
 
 
              35 
 
 
 
 
 

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The BEACON Study: Protocol for a pilot randomized controlled trial of smartphone-
assisted problem solving therapy in men who present with intentional self-harm to 
Emergency Departments in Ontario 
 
 
1. FUNDING 
 
The Ontario SPOR Support Unit (OSSU) is funding the costs for the BEACON trial 
and recruitment of 100 men in 5 Emergency Departments across Ontario. OSSU is a 
partnership between the Government of Ontario and the Canadian Institutes of Health 
Research (CIHR). Funding for this trial covers the cost of research staff salaries; capacity 
building; study-related expenses; including the cost of the smartphone application, statistical 
analyses and knowledge translation; as well as meetings and organizational costs.  
 
2. ROLES AND RESPONSIBILITIES 
 
2.1. Contributorship 
 
The following individuals assisted with the development of this study protocol: Drs. 
Simon Hatcher1, Marnin Heisel2, Monica Taljaard1, Kednapa Thavorn3, Daniel Corsi4, Ayal 
Schaffer5, Sakina Rizvi6, Ian Colman7, Mark Sinyor8, Sidney Kennedy6, Christian 
Vaillancourt1, Venkatesh Thiruganasambandamoorthy1, John Lavis9, Paul Links10, 
Christopher Mushquash11, Peter Voros12; and Valerie Testa1, Sarah MacLean4, Megan 
Schellenberg13, Julie Kathleen Campbell14, Alicia Raimundo15 and Alaaddin Sidahmed15. 
 
2.1.1. Author’s Contributions 
 
Drs. Simon Hatcher and Marnin Heisel conceived of the study and are the grant 
holders. Dr. Monica Taljaard provided expertise in the design of randomized controlled trials 
(RCTs). Dr. Daniel Corsi provided statistical expertise in designing the clinical trial and will 
be conducting the primary statistical analysis. Dr. Kednapa Thavorn designed a health 
economic evaluation and will supervise the health economic analysis. Valerie Testa and 
Sarah MacLean assisted with the drafting of the study protocol. All authors contributed to 
                                                     
 
1 University of Ottawa; Ottawa Hospital Research Institute 
2 Western University; Lawson Health Research Institute 
3 University of Ottawa; Ottawa Hospital Research Institute; Institute for Clinical Evaluative 
 

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refinement of the study protocol and approved the final manuscript. 
 
2.2. Sponsor contact information 
 
This is an investigator-initiated clinical trial and is sponsored by the Ottawa Hospital 
Research Institute (OHRI): 
 
Trial Sponsor: Ottawa Hospital Research Institute (OHRI) 
Sponsor’s Reference: 20150765 
Contact name: Dr. Duncan Stewart 
Address: 501 Smyth Road, Ottawa, ON K1H 8L6 
Telephone: (613) 798-5555, ext.79017 
Email: djstewart@ohri.ca  
 
The sponsor (OHRI) had no role in the design of this study and will not have any role during 
its execution, analyses, interpretation of the data, or decision to submit results. 
 
2.3. Committees 
 
2.3.1. Principal Investigator and co-Principal Investigator: 
• Design and conduct of the BEACON Study;  
• Preparation of protocol and revisions;  
• Preparation of study documentation; 
• Organization of steering committee meetings; 
• Publication of study reports; and 
• Participation as members of Trial Management Committee (TMC). 
 
2.3.2. Steering Committee (refer to title page for members): 
• Approval of the final protocol; 
• All co-Investigators at each intervention site will be steering committee 
members; 
• Recruitment of patients and liaising with Principal Investigator and co-
Principal Investigator; and 
• Reviewing progress of study and, if necessary, approval of changes to the 
protocol and/ to facilitate the smooth running of the study. 
 
2.3.3. Trial Management Committee (TMC): 
• Includes Principal Investigator, co-Principal Investigator, Clinical Research 
Program Manager and Research Coordinator; 
• Study planning; 
• Organization of Steering Committee meetings; 
• Organization of Data and Safety Monitoring Committee (DSMC) meetings; 
• Provide annual reporting to Research Ethics Board; 
• Serious Adverse Event (SAE) reporting to DSMC and Research Ethics Board 
(REB); 
• Responsible for Master Tracking Log; 
• Budget administration and contractual issues with individual centres; 

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• Advice for lead investigators; 
• Coordination of study monitoring; 
• Assistance with REB applications; 
• Data verification; and 
• Randomization. 
 
2.3.4. Data and Safety Monitoring Committee (DSMC): 
• Comprised of four members from the following fields of expertise: 
statistics/biostatistics, epidemiology, methodology, psychiatry and the ethics of 
clinical trials. 
• Ensures the ongoing safety of study participants; 
• Reviews the conduct of the study, including protocol violations and deviations; 
• Reviews data on participant recruitment, accrual, and retention, as well as 
assessments of data quality, completeness, timeliness, data retention, data 
storage, data transmission and data access; 
• Reviews Adverse Events (AEs) and Serious Adverse Events (SAEs) reported 
between meeting dates; 
• Protects the confidentiality of the study data and the DSMC discussions; and 
• Makes recommendations to continue, modify, or terminate the study. 
 
2.3.5. Lead Investigators 
 
At each participating site, a site co-Investigator will be identified, to be responsible 
for identifying and recruiting participants, collecting data, and completing all study 
documentation, along with coordinating follow up of study participants and adherence to 
study protocol. All site co-Investigators will be Steering Committee members. 
 
3. INTRODUCTION 
 
3.1. Background and Rationale 
 
3.1.1. Why is Intentional Self-Harm an Important Problem? 
 
Definition of Self-Harm 
We define self-harm as intentional self-poisoning or self-injury, whether or not there 
is clear evidence that the act was intended to result in death. Previous terms used include 
“attempted suicide” and “deliberate self-harm”; however, patients’ motives for self-harm are 
highly variable, as a person may have more than one motive and motivation is difficult to 
assess and stated intent can fluctuate with time. In line with usual public policy in health and 
social care, we use the term ‘self-harm’ – avoiding the word ‘deliberate’ because many 
service users dislike its connotations and as it ignores/simplifies the issue of ambivalent and 
co-existing wishes to live and to die. We opted to use the term “self-harm” rather than Non-
Suicidal Self-Injury (NSSI), a term being increasingly used in the clinical literature [1], given 
that it is associated with risk for lethal and non-lethal self-harm and as some individuals 
engage in self-harm with suicidal intent at times, and without stated suicidal intent at other 
times.  The term “self-harm” also focuses on behaviour rather than on its motivation, which is 

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often complex, multi-determined, and open to interpretation and recall bias and historical 
revision. 
 
Presenting to Hospitals with Self-Harm is Common 
 
In Ontario, the number of people who present to hospital Emergency Departments 
with self-harm is difficult to ascertain accurately due to chronic under-detection and variable 
inconsistency in the definition and recording of self-harm episodes. The Canadian Institute 
for Health Information (CIHI) estimates the 2014 Ontario provincial rate of self-harm to be 
61 per 100,000 population members, resulting in an estimate of approximately 8,250 
Emergency Department presentations a year, province-wide [2]. However, local data 
collected from Ottawa Emergency Departments indicate approximately 1,600 presentations 
per year, reflecting a rate of 123 per 100,000 a year, or approximately double that estimated 
by CIHI for this region.  Therefore, the provincial rate for Ontario may exceed 16,000 unique 
self-harm episodes per year. The under-detection of self-harm is further compounded by the 
recognition that official statistics do not capture those cases that did not involve a 
presentation to hospital or other healthcare services, and under-detection or misclassifications 
of presentations for self-harm. This issue has been identified as a significant problem by 
Statistics Canada [3].  
 
The most common form of self-harm seen in Emergency Departments, accounting for 
approximately 80% of all episodes, is the intentional consumption of an excess of a medicinal 
or toxic substance. Injuries, most commonly including self-cutting, account for the remaining 
15-20% of episodes. Two-thirds of patients presenting to Emergency Departments for the 
treatment of self-harm are under 35 years of age, with a mean age of approximately 30 [4, 5]. 
Self-harm occurs more commonly in lower socioeconomic groups. In Ontario, hospitalization 
rates for those from the most affluent sectors of the community are 26% lower than the 
provincial average [6]. There is also evidence to suggest that the rate of self-harm is 
increasing in Ontario, especially in younger adults [6].The number of deaths by suicide 
among older men is increasing secondary to the aging of the vast baby-boom cohort, adding 
further impetus to the need to enhance mental healthcare for at-risk men [7]. 
 
Self-Harm is Related to Suicide, Premature Mortality and High Use of Services 
 
Self-harm has a strong association with suicide: 1.6% of people presenting to 
Emergency Departments with self-harm will die by suicide within one year (95% confidence 
interval 1.2 to 2.1%), with the incidence rate being almost double in men compared to 
women (2.7% vs 1.2%) [8]. After five years approximately four percent of individuals who 
have presented to the Emergency Department for the treatment of self-harm die by suicide 
[8]. This risk is more than 50 times greater than the general population rate and is associated 
with a 40-year reduction in average life expectancy [8]. A recent retrospective study of 
individuals who died by suicide in Southwestern Ontario identified a history of self-harm in 
over a third of decedents [9]. As presentation to the Emergency Department with self-harm is 
a major identifiable risk factor for suicide, with at least one quarter of deaths by suicide being 
preceded by a hospital visit due to non-fatal self-harm in the previous year [10, 11], it is 
likely that any reduction in the repetition of self-harm will be mirrored by a decline in 

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subsequent deaths by suicide. The Canadian Association for Suicide Prevention (CASP) 
blueprint for a national suicide prevention strategy has also identified people who have 
attended hospital because of non-fatal self-harm as a high risk group to target in order to 
prevent suicide [12]. 
 
Mortality from non-suicidal causes is also high for those who self-harm, with 
significantly more than the expected numbers of deaths from natural causes and from 
accidents [13]. Some studies report an all-cause mortality of 15% five years after a hospital 
presentation with self-harm with two thirds of deaths due to non-suicide causes [14]. Being 
male, single and repeated attempts are risk factors for premature mortality. A recent 
population-based cohort study investigating administrative datasets in the province of Ontario 
discovered that: “all-cause mortality following a first episode of self-poisoning was 1,107 per 
100,000 person-years…[with] nearly half of all deaths being suicides, accidents or [of] 
undetermined intent” [15]. These premature deaths are greatly over-represented among young 
people and the potential years of life lost in the community are many. 
 
Individuals who self-harm are frequent users of health and social services [16]. 
Approximately 10% of those who present in an Emergency Department following self-harm 
will engage in repeat self-harm in the following month and up to 27% after six months [17]. 
Recurrent self-harm is associated with significant distress and many unresolved interpersonal 
problems [18]. 
 
Why Focus on Men? 
Whereas only four out of ten people who present to the Emergency Department with 
self-harm are men, they represent nearly two-thirds of those who die by suicide after an index 
episode of self-harm and they are also far more likely than women to die of premature death 
from other causes [13]. In Ontario, from 2006-2008, 75% of those who died by suicide were 
men [19].  The rates are even more pronounced in indigenous communities, with suicide rates 
of 126 per 100,000 young men (15-24) compared to a rate of 24 per 100,000 in non-
Indigenous men of the same age [20]. Men who self-harm are more likely to misuse alcohol 
compared to women; for instance, in one large study in the U.K., 45% of 7,893 men who 
presented with self-harm misused alcohol compared to 29% of women [21]. Further, men 
repeat self-harm at similar or higher rates than women; for example, a study conducted in 
Western Northern Ireland revealed an annual repetition rate of 19.3% in men compared to 
16.8% in women [22]. Previous trials have found that providing generic treatments to 
everyone is not particularly effective [23]; effective interventions target health behaviours 
and values consistent with the target group. The intervention we will offer builds on previous 
work by trying to extend the range and intensity of a focused psychotherapy by 
supplementing it with a sophisticated smartphone application that has already demonstrated 
its effectiveness in men with substance abuse disorders [24]. We will be offering an 
intervention specifically designed for men who self-harm who, historically, are difficult to 
engage in psychotherapeutic treatment and who are more likely than women to have 
substance abuse problems [25]. 
 
 
 
Summary of Relevant Studies of Psychological Therapies After Self-Harm 

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A 2012 U.S. review of literature on the screening and treatment of suicide risk 
indicated that trials among individuals who presented with self-harm to be limited by lack of 
power, although "trends suggested incremental benefits from some interventions (in 
particular, Problem-Solving Therapy (PST) for patients aged 15 or older)" [26]. The 2011 
National Institute for Health and Care Excellence (NICE) guideline on management of self-
harm (followed by a further NICE search and published update in 2014) found little that is 
likely to help with routine practice but concluded that there was sufficient evidence to 
recommend “a well conducted RCT” of psychosocial interventions [27]. The recently 
updated 2016 Cochrane review on interventions following self-harm found 55 trials involving 
17,699 participants, of which 18 trials investigated cognitive behaviour therapy (CBT) [23]. 
Here, CBT included problem solving therapy which is a cognitive therapy focused on current 
difficulties which aims to teach participants a cognitive skill, namely problem-solving, that 
can be applied across contexts and situations. The authors found there was a significant 
treatment effect for CBT compared to usual treatment at final follow-up, with fewer 
participants repeating self-harm (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.55 to 
0.88; number of studies k = 17; N = 2,665; GRADE: low quality evidence), but with no 
reduction in the frequency of self-harm (mean difference (MD) -0.21, 95% CI -0.68 to 0.26; k 
= 6; N = 594; GRADE: low quality) [28]. The authors concluded that CBT, including PST, 
requires further investigation in order to clarify which patients benefit from these types of 
interventions.  They further noted the need for more information about potential sex 
differences in the manner in which psychosocial interventions might work.  
 
The potential impact of this study is that it could improve patient and health system 
outcomes by decreasing repeat episodes of self-harm and deaths by suicide, presentations to 
Emergency Departments (as well as linked hospital admissions), and ultimately reduce 
healthcare costs.  
 
Summary of Relevant Studies of Blended Therapy in the Treatment of Self-Harm 
 
The electronic support of psychotherapy in the treatment of mental disorders has been 
called “blended care,” referring to the combination of online and face-to-face therapy in one 
treatment protocol [28]. Blended therapy potentially offers numerous benefits to both patients 
and health care providers, including increasing the intensity of mental health treatment 
without a reduction in the number of sessions [29], increasing patient agency by fostering 
increased self-management skills [30] as well as case management benefits for mental health 
professionals [31]. Studies have also shown that blended therapies have the potential to 
reduce the number of face-to-face therapy sessions required by patients, thereby reducing the 
total cost to the health care system [32]. These interventions may be especially beneficial for 
the financially and geographically disadvantaged, including those individuals whose financial 
situation prohibits their seeking care during the work day, and those residing in rural and 
remote regions. 
 
The use of smartphone applications for the self-management and monitoring of 
mental health have been found to be acceptable by both research participants [33] and the 
wider community as long as appropriate privacy and security measures are taken [34]. There 
have been only a small number of studies that have investigated blended therapy but no 
studies that have examined blended therapy in secondary health care settings or in patients 

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who are at high risk for suicide. Large trials in routine clinical settings are needed in order to 
assess the effectiveness of blended therapy interventions in those suffering from mental 
disorders. In recognition of this, the European Commission has funded a large study, the 
European Comparative Effectiveness Research on Internet-Based Depression Treatment 
project (E-COMPARED) in which the effectiveness of blended therapy for treating 
depression will be assessed in a RCT in eight European countries [32]. However, the E-
COMPARED study specifically excludes suicidal participants and those with co-morbid 
mental disorders, such as bipolar disorder or substance abuse.   
 
Assessment, Care and Discharge from the Emergency Department 
 
People attending Emergency Departments following self-harm receive variable levels 
of care in Ontario, and there is no standard protocol for therapy. Many are not assessed for 
psychological needs, and the little psychological therapy available is usually not covered by 
provincial healthcare plans, and is thus only accessible to individuals with greater financial 
resources, including employer-paid supplemental health benefits. Published work from other 
countries confirm the fact that variation in the provision of care is the norm [35]. Local audit 
data from hospitals in Ottawa show that only four out of ten men who present with 
intentional self-harm are seen by a mental health professional, and few are offered an 
evidence-based treatment aimed at reducing their risk of suicide or repeated self-harm.  
 
Assessment of suicide risk is currently a Required Operating Practice for Canadian 
Hospital accreditation; however, individuals identified as being at-risk for suicide rarely 
receive recommended care. A cohort study of 7,355 Emergency Department presentations for 
self-harm in the U.S. found that less than half of those who presented with self-harm (47.5%) 
received any mental health assessment while in the Emergency Department [36]. The same 
study found that the lethality of self-harm was not associated with mental health assessment 
in the Emergency Department.  In a study of patients who presented to the Emergency 
Department with deliberate self-harm, Hickey, Hawton, Faag & Weitzel (2001) also found 
that those who were discharged from the Emergency Department without a psychiatric 
assessment were more likely to: be male, 20-34 years of age, have a previous history of self-
harm, to demonstrate difficult behaviour while in hospital and to be intoxicated than patients 
who were assessed prior to discharge [37]. Follow-up after discharge from Emergency 
Departments for many disorders is often poor, with one study in Ontario finding that between 
15% and 31% of patients discharged from an Emergency Department with chronic heart 
failure, diabetes or chronic obstructive lung disease did not see any physician within 30 days 
of their Emergency Department contact [38]. Fewer than one in three primary care physicians 
in Canada report being told when their patients attend an Emergency Department [39].  
 
Following intentional self-harm, even fewer patients receive outpatient mental health 
follow-up, with only half attending an appointment with a mental health professional within 
30 days of presentation to the Emergency Department for an episode of self-harm [36]. Here, 
too, policies vary by institution regarding the acceptable duration between discharge and an 
outpatient mental health visit. Even in RCTs, which typically involve rigorous specification 
in methods of approaching, recruiting, and determining eligibility of patients, the proportion 
of people who consent and then actually receive treatment is low, with one study reporting 
38% of people randomized to cognitive behaviour therapy attending no clinical sessions [40] 

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and another trial finding 20% of people consenting to PST having received no sessions [41]. 
Methods to address the low rate of engagement include providing patients with a written 
discharge plan in the Emergency Department [28]; enabling Emergency Department 
physicians to make electronic bookings for follow-up; staff training; and feedback on the 
proportion of people receiving care after leaving the Emergency Department [42]. The U.S. 
Suicide Prevention Resource Center (SPRC) has produced a “consensus guide” for caring for 
adult patients at high-risk of suicide in the Emergency Departments which recommends a 
package of brief patient education; safety planning; lethal means counselling; rapid referral; 
and caring contacts, which include crisis line information [43]. They also recommend 
focused interventions targeting men in their middle years at elevated risk for suicide [43]. A 
Cochrane Systematic Review of interventions to improve outpatient referrals from primary 
care to secondary care concluded that local educational interventions and dissemination of 
guidelines with structured referral sheets were effective strategies [42]. These features are 
included as part of the BEACON Suicide Prevention Smartphone Application in this study. 
 
Rationale 
Whilst clinical interventions involving technology appear attractive there are significant 
obstacles to implementation including clinicians perceptions that they may lower barriers to 
access (sic); organisational difficulty in incorporating technology into practice particularly 
around issues of confidentiality and privacy (especially when considering “high risk” patients 
in mental health settings); and a lack of evidence that adding technological interventions to 
existing services provide any significant benefits. This pilot aims to provide preliminary 
evidence to address these concerns and pave the way for a definitive multi-site individualised 
RCT and implementation study. 
 
3.2. Objectives and Hypotheses 
 
3.2.1. Primary Objective & Hypotheses 
 
The primary objective of this study is to assess whether a multi-site individualised 
RCT of the management of men who presented with self-harm is an appropriate trial design 
and is feasible with regard to i) eligibility, recruitment and retention ii) patient use and 
acceptability of the blended intervention iii) to inform the primary outcome measure and 
sample size for a definitive RCT and iii) adherence to the protocol.  
 
3.2.2. Secondary Objectives & Hypotheses 
 
The key secondary objectives are to determine whether, in men who present to the 
Emergency Department with self-harm, smartphone-assisted PST designed specifically for 
men results in better health-related outcomes including: a decrease in the severity of 
suicidality, a decrease in the severity of depression symptoms, a decrease in the severity of 
anxiety symptoms, improved overall health, better health-related quality of life and lower 
rates of alcohol/drug misuse. We will also examine the mechanism of change by assessing 
problem solving skills assessed by the Social Problem Solving Inventory. 
 
We hypothesize that participants who complete three sessions of smartphone-assisted 
PST or more, will experience statistically significant improvements in participant scores on 
the following measures: 

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• Meaning in life; and 
• Perceived social supports. 
 
We also hypothesized that the study intervention (three sessions or more) will lead to 
amelioration of the following: 
• Suicidality; 
• Depression symptoms; 
• Anxiety symptoms; 
• PSTD symptoms; and 
• Health care costs. 
 
We expect that the treatment outcomes will be moderated by the following variables: 
• Conformity to “masculine” gender norms; 
• Exposure to suicide in the media; 
• Use of the internet to research means of self-harm; and 
• Use of the internet to access self-harm resources. 
 
3.3. Study Design 
 
 
 
  
This randomized controlled pilot trial will study the feasibility and potential 
effectiveness of a blended problem-solving therapy (BEACON) compared to face to face 
problem solving alone in men who present to Emergency Departments with intentional self-
harm. Exposure to the study intervention will be dichotomized at three sessions (i.e. 
participants who complete 0-2 sessions versus those who complete 3 sessions or more). 
 
All adult men (≥ 18 years of age) who present to one of the five intervention sites 
with intentional self-harm will be approached with information about the study. Patients who 
are interested in participating in the study will be scheduled for a Baseline Visit with a 
delegated study staff member who will obtain written informed consent and screen the 
patients for eligibility to participate in the study. We propose to manage the transition from 
the Emergency Department to outpatient care by providing staff training, written information 
for patients and an electronic referral service at each site.  
 
Patients who are eligible and consent to participate in the study will be randomized to 
receive six sessions of face-to-face PST or six sessions of face-to-face PST supplemented by 
the  BEACON Suicide Prevention smartphone application. PST sessions will be delivered by 
a trained Research Therapist. PST Sessions and other study visits may take place over 
videoconference, using a platform such as MS Teams, Zoom Health, or OTN.. 
4. METHODS 
 
4.1. Participants, Interventions and Outcomes 
 
4.1.1. Study Setting 
 
This study will be conducted in five hospitals across Ontario: Kingston General 
Hospital; Unity Health - St. Michael’s Hospital Toronto; Sunnybrook Hospital Toronto; 
Victoria and University Hospitals, London; and The Ottawa Hospital, Ottawa. Recruitment 
will occur through staff that see these patients clinically in the Emergency Department of 

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these hospitals.  
4.1.2. Eligibility Criteria 
 
Eligible participants will be men aged 18 years or older who present to Emergency 
Departments with intentional self-harm regardless of whether they are admitted to hospital or 
not.   For the purpose of this study, “intentional self-harm” is defined as intentional self-
poisoning or self-injury, whether or not there is evidence that the act was intended to result in 
death.  
 
Inclusion Criteria 
1. 
Identifies as Male. 
2. 
18 years of age or older. 
3. 
Has presented via the Emergency Department with self-harm in the preceding 4 
weeks; 
4. 
Able to read and understand English, French or read or understand Oji Cree. 
5. 
Willing to attend six problem-solving therapy sessions for a period of up to eight 
weeks. 
6. 
Willing to use a smartphone application to facilitate the treatment of self-harm. 
7. 
Willing to return to hospital for follow-up appointments. 
8. 
Willing and able to provide informed consent. 
9. 
Willing to use e-mail for study activities. 
Exclusion Criteria 
1. 
Identifies as female. 
2. 
Has presented to the Emergency Department for a reason other than self-harm. 
3. 
In the opinion of the investigator is unlikely to commit to a six-month study. 
 
Participants are not required to have a smartphone with a data plan in order to participate. 
Participants who do not have a smartphone with a data plan will be provided with one pre-
paid smartphone with voice and data services for a period of six months from the date of their 
study enrollment. Provision of a second phone in the event of loss or theft will be evaluated 
on a case by case basis. 
 
4.1.3. Interventions 
 
All individuals will receive usual care and six sessions of PST. Individuals 
randomized to the blended-therapy arm will be have six sessions of PST supplemented by the 
BEACON platform, developed in partnership with CHESS Health Inc. 
(http://www.chessmobilehealth.com).  As of October 2019, CHESS Health Inc. is no longer 
involved with the BEACON app or the BEACON study in any way. The OHRI is responsible 
for all maintenance and operation of the app. The original version of this smartphone 
application was tested in an RCT in male Veterans in the USA [24] and found to be effective 
in reducing harmful substance use. It has been re-designed for the purpose of this study to 
facilitate the treatment of self-harm in men who present to the Emergency Department. This 
smartphone application contains eight integrated sections (refer to Figure 2): 
Table 1. Participant Eligibility Criteria 

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• Profile: Participants are asked to setup a user profile, which includes an image and their 
personal motivation/mantra as well as set up a safety plan to prevent future self-harm. 
This will be done in conjunction with their therapist at their initial PST session. 
• Surveys: Participants will be prompted to provide an update on their mood.  
• Therapy: This section will walk the user through the steps of problem solving and end 
with the creation of a smart goal. This section will allow not only the creation of new 
goals based on current problems, but also allow users to look at the goals they’ve created 
and update their progress on them.  The creation of a goal will be a step by step process 
that follows the principles of PST. 
• Journal: The journal allows participants to 
create a written entry complete with images 
and 
audio. The smartphone application will then 
check back in with the user after a chosen 
amount of time to ask if they are still feeling 
upset. Should they still be feeling negatively 
after the chosen amount of time has passed 
they will be recommended an activity or 
action to help negative feelings pass. 
• Connect: Allows participants to maintain 
instant and time-delayed contact with their 
important contacts (family, friends, 
coworkers) as well as their therapist. 
• Progress: This feature allows participants to 
monitor their progress throughout the study, 
including their achievements, mood log 
history and trackable history. 
• Resources: In this section of the smartphone 
application, participants will have access to 
content uploaded by their clinicians, which can be targeted to participants on an as-
needed basis. Participants will also have access to a map which geo-locates the nearest 
local mental health services as well as a list of local crisis line telephone numbers which 
they may access as needed. 
• BEACON: When participants are in crisis, they may access the BEACON screen. This 
section of the smartphone application allows participants to assess their current situation 
and safety plan for warning signs that they may be at risk for subsequent self-harm. It also 
provides activity recommendations to help participants reduce stress, including relaxation 
and breathing exercises. Participants also have quick access to their important contacts 
directly from this screen, including their therapist and emergency contacts. At any time, 
participants can also press the BEACON button and be connected to a crisis line. 
 
Figure 1. BEACON Suicide Prevention Smartphone 
Application Navigation 

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PST has been used previously by this research team. Staff training will take place over two 
days followed by weekly supervision. Supervision will be provided by the Principal 
Investigator using the Ontario Telemedicine Network (OTN) for therapists in different 
locations. Existing PST training materials can be found at the following link: 
www.problemsolvingtherapy.ac.nz. Adherence to the therapy will be assessed by number of 
sessions attended and an adherence tool (unpublished) used in previous studies.  
4.1.4. Outcome Measures 
 
Primary Outcome Variable 
Feasibility 
To evaluate the primary outcome of the study, feasibility, we will consider the following: i) 
eligibility, recruitment and retention ii) patient use and acceptability of the blended 
intervention iii) the primary outcome measure and sample size for a definitive RCT and iv) 
adherence to the protocol. 
i) 
Eligibility, Recruitment, and Retention 
For eligibility, we will retain screen failure data of those participants who have consented 
to be in the study to assess the frequency at which each inclusion/exclusion criteria are 
not met. We will assess recruitment by comparing group level demographics at each 
hospital of men who presented to the ED with self-harm compared with those who 
enrolled in the study. Lastly, for retention we will assess the characteristics of those who 
complete 0-2 sessions, 3-6 sessions but not the 6 month assessments and those who 
complete 3-6 sessions and all outcome assessments.  

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We will consider these feasibility objectives to be successfully met if: 
1) At least 20% of eligible men consent to take part in the study. 
2) That at least 1 patient per week, on average, is randomised in each participating 
site 
3) That 50 of the 100 participants complete at least 3 sessions of face to face PST 
4) That 70 of the 100 participants complete questionnaire outcomes at 6 months 
ii) 
Patient Use and Acceptability 
We will assess patient use of the application using de-identified usage statistics including 
number of BEACON presses, number of red pins activated, and any periods of app 
inactivity (more than 7 days). We will also conduct qualitative interviews with 
participants to assess the use of the application and the acceptability of the blended 
therapy, as well as other treatments used by the participants.  
iii). Inform future primary outcome measures and determine sample size for a definitive 
RCT 
We will measure the severity of suicidal ideas at six months as measured by the Beck 
Scale for Suicide Ideation (BSS). This is a 24-item self-report questionnaire for detecting and 
measuring the current intensity of participant’s attitudes, behaviors, and plans to die by 
suicide during the past week. It consists of five screening items, if the participant reports any 
active or passive desire to die by suicide, then an additional 19 items are administered. 
Participants are asked to rate each item (i.e. “Wish to live”) on a scale from 0 (moderate to 
strong) to 2 (none). Responses are then scored according to the following three factors, with 
total scores ranging from 0 to 48 with higher scores indicating greater suicidality. 
• Active Suicidal Desire (10 items); 
• Passive suicide Desire (3 items); 
• Preparation (3 items). 
The BSS has strong psychometric properties, with strong internal consistency (α=0.89) and 
high inter-rater reliability [44, 45]. It has also been found to be significantly correlated with 
self-harm measures on the Beck Depression Inventory (BDI) [44] and has been found to be a 
strong predictor of admission to hospital for suicidality [46]. The BSS has been frequently 
used in sucidology research as a criterion measure of suicidality, which makes comparisons 
to other clinical trials and subgroups possible [47, 48]. 
We will use the change in responses as well as the qualitative interviews to determine 
whether the BSS to measure suicidality is an appropriate outcome measure for the definitive 
RCT. We will also use the change in responses on the BSS to inform sample size calculations 
for the large RCT. 
Lastly, we will evaluate the responses of the secondary outcome measures, in combination 
with the qualitative interview responses, to determine which variables are critical to measure 
in the definitive RCT while minimizing participant burden. 
iv) 
Adherence to the protocol 

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We will evaluate any protocol deviations, planned or unplanned, as well as modifications site 
request to make to the conduct of the study at site submission to the REB. We will evaluate 
site level frequency of completion of the Therapy Adherence Form that is completed by the 
therapist at each study visit documenting which activities were completed. 
 
Secondary Outcome Variables 
Depression Symptoms 
 
Changes in depression scores over the study intervention period will be assessed 
using the Patient Health Questionnaire (PHQ-9), a 9-item questionnaire that assesses the 
severity of depression symptoms experienced within the last two weeks. Participants are 
asked to rate each symptom of depression on a Likert scale from 0 (not at all) to 3 (nearly 
every day), with total scores ranging from 0 (minimal depression) to 27 (severe depression). 
The PHQ-9 has strong methodological properties with an internal consistency of 0.89 and 
strong test re-test reliability [49]. Increasing scores on the PHQ-9 have also been found to be 
correlated with deteriorating scores on all six subscales of the Medical Outcomes Survey 
Short Form-20 (SF-20) [50].  
 
This measure was selected not only for its strong psychometric properties but also 
because of its commonality. The PHQ-9 is often used as a screen tool for Major Depression 
Disorder (MDD) in primary care practice [51]. As such, in the case of an Adverse Event 
(AE), such as worsening depression scores, the familiarity of the PHQ-9 will facilitate 
interactions between study investigators and participant’s family physicians. 
Anxiety Symptoms 
 
Changes in anxiety scores over the course of this study will be assessed using the 
Generalized Anxiety Disorder questionnaire (GAD-7), a 7-item questionnaire that assesses 
the severity of anxiety symptoms experienced within the last two weeks. The initial 
validation study, conducted by Spitzer et al. (2006), demonstrated high internal consistency 
(α=0.92) and test-retest reliability (intraclass correlation = 0.83) [52]. Similar to the PHQ-9, 
the GAD-7 is familiar to primary care physicians, which will facilitate the coordination of 
care for study participants.  
Post-Traumatic Stress Disorder (PTSD) Symptoms  
 
Changes in PTSD symptoms during the study period will be evaluated using the 
Primary Care Post-Traumatic Stress Disorder Screen for DSM-5 (PC-PTSD-5) screening 
tool, which consists of five items which evaluate the presence of PTSD-related symptoms. 
The screening tool was initially developed and validated with male and female Veteran 
Affairs primary care patients [53]. Prins et al. (2016) recommend using a cutoff score of three 
(out of a possible five points) to detect possible PTSD, with a sensitivity of 0.93, specificity 
of ≥0.80 and efficiency of 0.63[53].  
Health-Related Quality of Life 
 
Health-related quality of life will be assessed using the EuroQol 5 Dimensions 

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questionnaire (EQ-5D-5L). This is a 5-item questionnaire that assesses health-related quality 
of life, including mobility, self-care, ability to participate in one’s usual activities, pain or 
discomfort, and anxiety or depression. The EQ-5D-3L was released in 1990 and asked 
participants to assess their health-related quality of life on a three-point scale from no 
dysfunction to extreme dysfunction. In 2005, the EQ-5D-5L was released to improve the 
sensitivity and reliability of the measure [54]. Respondents are now asked to rate their health-
related quality of life on a five-point Likert scale, with the following response categories: 
• Level 1: indicating no problem; 
• Level 2: indicating slight problems; 
• Level 3: indicating moderate problems; 
• Level 4: indicating severe problems; 
• Level 5: indicating extreme problems. 
 
The EQ-5D-5L is then able to define a unique health state based on the responses to 
each of the five dimensions of health described above. Respondents fall into one of 3,125 
different health states depending on their responses to the questionnaire. For instance, an 
overall score of 11111 indicates no problems on any of the five health dimensions, whereas a 
score of 12345 indicates that a respondent has no problems with mobility, slight problems 
with washing or dressing, moderate problems with doing usual activities, severe pain or 
discomfort and extreme anxiety or depression. The measure also includes a Visual Analogue 
Scale (VAS) which asks participants to evaluate their overall health on a scale from 0-100. 
 
Meaning in Life 
 
Previous research has demonstrated perceived meaning in life to be negatively 
associated with depression and suicidal ideation [55]. In the current study, meaning in life 
will be evaluated using the Experienced Meaning in Life Scale (EMIL) [56], which consists 
of four 10-item sub-scales: Creative, Experiential, Attitudinal and Ultimate meaning in life. 
The EMIL includes 40 items rated on a Likert scale from “strongly disagree” (1) to “strongly 
agree” (5), with higher scores reflecting greater perceived meaning in life. 
 
This measure was developed and validated with a community-based sample of older 
adults [56] and has high internal consistency (α=0.95). For the purposes of this study, we 
have will be using the Creative and Attitudinal subscales only in order to reduce the burden 
on participants and investigators. 
Perceived Social Supports 
 
Perceived social supports will be assessed using the Multidimensional Scale of 
Perceived Social Support (MSPSS) [57].  
The MSPSS is a 12-item questionnaire that addressing the following sources of 
perceived social support: Family, Friends or Significant Other. Each sub-scale consists of 
four-items that are rated on a seven-point Likert scale from “very strong disagree” (1) to 
“very strongly agree” (7). The MSPSS performs well psychometrically with high internal 
consistency and test-retest reliability (refer to Table 2). 

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Table 2. MSPSS Reliability Statistics 
Subscale 
Internal Consistency  
(α) 
Test-Restest Reliability  
(ICC) 
Family 
0.87 
0.85 
Friends 
0.85 
0.75 
Significant Other 
0.91 
0.72 
Total 
0.88 
0.85 
Source: Zimet et al., 1988 
Alcohol Misuse 
Alcohol misuse will be evaluated using the Alcohol Use Disorder Identification Test 
(AUDIT). Two versions of the AUDIT will be used in this study: the AUDIT-C is a 3-item 
questionnaire that assesses alcohol misuse. This will be used as a screening questionnaire, 
participants who score above 4 on the AUDIT-C will also be asked to complete the Full 
AUDIT (an additional seven questions). The AUDIT questionnaire is designed to assess the 
following four dimension of alcohol misuse: 
• Alcohol consumption (3 items); 
• Drinking behaviour (3 items); 
• Adverse reactions (2 items); 
• Alcohol-related problems (2 items). 
 
The validity of the AUDIT questionnaire has been established through an examination of 
sensitivity and specificity. Among those who were known to misuse alcohol, the AUDIT 
successfully detected an alcohol use disorder 99% of the time [58]. Similarly, among those 
who did not misuse alcohol, only 0.5% were categorized as potentially having an alcohol use 
disorder [59].  
Drug Misuse 
 
Drug misuse will be measured using the Drug Abuse Screening Test (DAST-10), a 
10-item questionnaire that assesses drug abuse within the last 12 months. Participants are 
asked to answer 10 questions about their substance use using a binary response of yes or no, 
with each response indicating a possible drug use problem being awarded one point. The total 
possible scores on this instrument range from 0 to 10, with higher scores indicating a greater 
likelihood of a substance use problem. The DAST-10 has been evaluated among psychiatric 
patients and has been found to have high internal consistency (α=0.94) [60] and a test-retest 
reliability score of 0.71 [61]. Scores on the DAST have been found to be significantly 
correlated with the frequency of drug use (r ranging from 0.19 to 0.55). However, this can be 
difficult to estimate as frequency of use is often drug-specific (i.e. marijuana compared to 
heroin) [61].  
Adherence to Masculine Gender Roles 
The increased risk for self-harm and suicide has been established in this protocol. As 
discussed earlier in this document, men are less likely to seek help for mental disorders, 
including self-harm, and are difficult to engage in psychological treatment. One potential 
explanation for this is gender role strain. That is, dominant forms of masculinity place 

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societal pressures on men to meet certain gendered expectations (i.e. emotional control, self-
reliance, and dominance). When individual men are unable to meet these expectations, they 
experience strain which may impact their behaviour in a number of problematic ways, 
including a resistance to seeking psychological help. 
The Conformity to Masculine Norms Scale [62] is a 94-item questionnaire that 
assesses the conformity to the following masculine gender norms: Winning, Emotional 
Control, Risk-taking, Violence, Power over Women, Dominance, Playboy, Self-Reliance, 
Primacy of Work, Disdain for Homosexuals, and Pursuit of Status. The CMNI performs well 
methodologically, with strong measures of internal consistency across all 11 subscales ((α 
ranging from 0.72 to 0.91; refer to Table 5 for more information)[62]. It is also strongly 
correlated with other measures of masculinity including: Brannon Masculinity Scale [63], the 
Gender Role Conflict Scale [64] and the Masculine Gender Role Stress Scale [65]. 
Table 3. Internal Consistency Statistics for CMNI Subscales 
Subscale 
Internal Consistency (α) 
Winning 
0.88 
Emotional Control 
0.91 
Risk-Taking 
0.82 
Violence 
0.84 
Power Over Women 
0.87 
Dominance 
0.73 
Playboy 
0.88 
Self-Reliance 
0.85 
Primacy of Work 
0.76 
Disdain for Homosexuals 
0.90 
Pursuit of Status 
0.72 
Total Conformity 
0.94 
Source: Mahalik et al., 2003 
The CMNI differs from other measures of masculinity in one key respect: while other 
measures assess the extent to which an individual has internalized the cultural beliefs 
associated with masculinity and the male role, the CMNI assesses an individual’s personal 
conformity to these established ideals. This is an important distinction when seeking to 
address gender role strain as it differentiates between the understanding of the importance 
and prevalence of gendered norms (i.e. emotional control) and an individual’s man’s ability 
to meet those gender role expectations in his own life. This, in turn, may lead to gender 
differences in help-seeking, making men more vulnerable to self-harm and suicide. For the 
purposes of this study, only the following subscales will be used: Emotional Control (CMNI-
EC) and Self-Reliance (CMNI-SR) as they are the most applicable to the study population. 
This will also reduce participant and investigator burden. 
Health Service Use 
Health service use will be captured using routinely collected administrative health 
data for participants obtained from the Institute for Clinical Evaluative Sciences (ICES). This 
includes: 

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• Previous hospitalizations for self-harm; 
• Presentation to hospital for self-harm; 
• Presentations to hospital for any reason other than self-harm; 
• Admission to hospital for any reason; 
• Outpatient appointment for any reason; and 
• Primary care visits. 
 
  
A questionnaire has also been adapted by the research team to capture data not 
available in ICES. Specifically, relevant questions from the Questionnaire on Healthcare 
Consumption and Productivity losses for patients with a Psychiatric Disorder (TiC-P) will be 
used to collect health service use and work productivity not otherwise captured. Items 
removed from the questionnaire are either optional as noted by the developers, are captured 
elsewhere in a more reliable manner (such as current medications or demographics), or were 
adapted to services in Ontario healthcare system. The TiC-P is a brief self-report 
questionnaire, taking most respondents less than 10 minutes to complete with good test-retest 
reliability (ICC=0.83) [66]. 
Problem-Solving Skills 
In order to assess the impact of the smartphone-assisted PST intervention, we will be 
assessing participant’s social problem solving skills throughout the study intervention period 
using the Social Problem Solving Inventory- Revised Short Form (SPSI-R:S) [67]. This is a 
25-item questionnaire that assesses individual's strengths and weaknesses in their problem-
solving abilities so that deficits can be addressed and progress monitored. This is a short form 
of the Social Problem Solving Inventory (SPSI), which had strong psychometric properties, 
including high internal consistency (α=0.94), test-retest reliability (ICC=0.87) and was 
correlated with other measures of stress and psychological symptomatology among both 
college students and community residents (refer to Table 6 below for more information): 
Table 4. Correlations Between SPSI Measures and Measures of Stress and Psychological Symptomatology in a 
College Student Sample and a Community Resident Sample 
 
College Students 
Community Residents 
SPSI 
SPSI 
DSP/TSS 
-0.45** 
-0.56** 
DSP/EES 
-0.35** 
-0.43* 
DSP/PMS 
-0.14 
0.40* 
DSP/ERS 
-0.53** 
0.49** 
PPC 
-0.26** 
-0.19 
SCL-90-R 
-0.37** 
-0.45** 
Source: D’Zurilla & Nezu, 1990 
Note: SPSI=Social Problem-Solving Inventory; DSP = Derogatis Stress Profile; TSS = Total Stress Score; 
EES =- Environmental Events Score; PMS = Personality Mediators Score; ERS = Emotional Response 
Score; PPC = Personal Problems Checklist; SCL-90-R = Symptom Distress Checklist-90-Revised Global 
Severity Index.  
* p <0.05 
** p <0.01 
Influence of the Media on Suicide 
Numerous studies have shown that mainstream media reports on suicide influence 

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some people to attempt and die by suicide through a copycat phenomenon known as the 
Werther Effect [68–71]. This has not been well described in males who present to the 
emergency room after an episode of self-harm. Adding this measure will help determine the 
extent to which a Werther Effect occurs in this population and could inform future prevention 
efforts both at a population level and also within the application (e.g. blocking media stories 
with suicide-related content).  
In order to assess the potential impact of the media on self-harm presentations during 
the study intervention period, each participant will be asked if, in the month prior to their 
self-harm episode, they were aware of any high profile suicides in the news, whether they 
used the internet to research self-harm methods and whether they used the internet to get 
access to help for their emotional distress.  
 
All outcome measures will be administered via an electronic data capture system 
(EDCS) for all visits. The system used is outlined in Section 4.3.2 Data Management of this 
protocol. The following questionnaires are not included in the EDCS and will be completed 
as an interview by the delegated study staff member and a summary entered into the EDCS: 
BSS, SPSI-R:S and demographics. Administration will occur as per Time and Events 
Schedule in Table 5. 
 
4.1.5. Sample Size 
 
Calculating sample size for pilot studies is a controversial area. Calculations may be based on 
estimation of important parameters with sufficient precision[72], the likelihood of unforeseen 
problems[73] or rules of thumb such as 12 participants per group[74], at least 9% of the main 
trial's sample size[75] , or at least 50 participants[76] . Further there is a lack of guidance on 
calculating sample size for pilots of multicenter trials where clustering at the different sites 
may be a factor. Based on previous randomised controlled trials of interventions in this 
population we expect that in the main trial the effect size will be small and the sample size 
large. We have designed the pilot to estimate the proportion of patients who would meet our 
feasibility criteria using confidence intervals. Based on our experience with previous studies 
conducted in this population we estimate that enrolling 100 patients, with 20 participants 
consenting in each site, would allow us to assess our feasibility outcomes and maximize the 
chance of identifying unexpected barriers to carrying out a larger trial across multiple centers. 
 
4.1.6. Recruitment 
 
After presentation to an Emergency Department with self-harm, male patients may be 
approached by Emergency Department staff with information about the study. A delegated 
study staff member at each site may check-in regularly with Emergency Department staff to 
confirm there are no potentially eligible participants. At sites where medical records have a 
“Consent to be Contacted for Research” option, a delegated study staff member at the site 
will routinely review the Electronic Medical Records at their respective site to ensure that no 
potentially eligible patients have been missed. These patients will be provided with 
information about the study by telephone. Patients interested in participating in the study will 
be scheduled for a Consent and Baseline Appointment with a delegated study staff member. 
The consent visit and other study visits may occur using videoconference platforms such as 
MS Teams, Zoom for Healthcare, Zoom in Epic or OTN. Electronic signatures will be 

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obtained on consent forms in any circumstance where in-person visits are not possible.. At 
their consent visit, patients will be provided with information about the study and will have 
an opportunity to ask any questions they may have pertaining to the study. The delegated 
study staff member will then conduct the informed consent discussion in accordance with 
ICH Good Clinical Practice (GCP) guidelines with interested patients. Once they provided 
written informed consent, participants will be screened for eligibility to participate in the 
study. All eligible participants will be scheduled for a Baseline Visit. At the Baseline Visit, 
participants randomized to the BEACON arm will be guided in how to download the 
BEACON smartphone application and a delegated study team member will walk them 
through the onboarding process and set-up of their profile. Once this is complete, participants 
will be asked to complete all necessary Baseline Intake assessments and will be referred for 
their first PST session, to be conducted by a delegated study staff member. In order to limit 
participant burden, they will have the choice to either complete their baseline visit and first 
PST session in one study appointment or to split them into two study appointments. Prior to 
their first visit, participants will receive an email containing a secure link to complete their 
baseline assessments. For in person visits, the participant can complete the questionnaires 
directly on a study computer. 
 
 
4.2. Assignment of Interventions 
 
4.2.1. Allocation to Intervention 
 
Five (5)sites in Ontario have agreed to participate in this pilot RCT. Randomization 
for this study will occur with 2:1 (67:33) allocation in favour of the blended therapy model. 
Given the small sample size, there will be no stratification across sites to ensure an equitable 
allocation to the conditions. A web randomization system hosted by the Ottawa Methods 
Centre (OMC) will be used. Participants will be randomized by each site coordinator using 
the web system as they are enrolled.  
4.2.2. Blinding 
 
There is no blinding in this study as all patients who consent to participate in this 
study will receive at least PST therapy. It would not be practical or possible to blind the 
receipt of the mobile application as both the participant and therapist will be using the 
platform. 
4.2.3. Participant Timeline 
 
 
 
 
 
 
Figure 2. Participant Timeline 

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4.3. Data Collection, Management and Analysis 
 
4.3.1. Data Collection 
 
Data Collection Methods 
All outcome measures will be administered via an Electronic Data Capture System 
(EDCS), with the exception of the SPSI-R:S and the BSS which will be completed on paper 
and entered into the EDCS by delegated site staff, at the all visits as per the table below (refer 
to Appendix A for estimated completion times for each measure). When visits occur via 
video conference, the SPSI-R:S and the BSS will be administered using screen sharing or 
interview.  
Table 5. Outcome Variables 
Outcome 
Data Source 
Explanation 
Administered 
Demographic and descriptive information 
Demographic 
Information 
Baseline 
Questionnaire 
To describe similarities and 
differences between the 
groups 
Session 1 (Baseline 
Visit) 
Influence of media 
on self-harm 
Baseline 
Questionnaire 
To describe similarities and 
differences between the 
groups 
Session 1 (Baseline 
Visit) 
Masculinity 
CMNI-EC; CMNI-
SR 
To describe similarities and 
differences between the 
groups 
Session 1 (Baseline 
Visit) 
Primary Outcome 
Suicidality  
BSS 
To assess the impact of the 
smartphone-assisted PST 
intervention 
 Baseline Visit; 
Session 6; 12 weeks, 6 
months 
Secondary Outcomes 
Severity of 
depression 
symptoms 
PHQ-9 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 

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Severity of Anxiety 
Symptoms 
GAD-7 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
PTSD 
PC-PTSD-5 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Health-related 
quality of life 
EQ-5D-5L 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Meaning in Life 
EMIL-Attitudinal; 
EMIL - Creative 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Social Support 
MSPSS 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Alcohol use/misuse 
AUDIT 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Drug use/misuse 
DAST-10 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Health Care Use and 
Cost 
NARCS (ICES); 
OHIP (ICES); TiC-
P 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Problem-Solving 
Skills 
SPSI-R:S 
To assess the impact of the 
smartphone-assisted PST 
intervention 
Baseline Visit; Session 
6; 12 weeks, 6 months 
Data Sources: NACRS, National Ambulatory Care Reporting System; OHIP, Ontario Health Insurance Plan Claims 
Database 
 
The following data will be collected as part of the assessment of feasibility and acceptability: 
Table 6. Assessment of Feasibility and Acceptability 
 
Retention 
Data Collection Method 
Data Collected 
Program documentation and observation (to 
assess fidelity, dose and reach) 
Number of PST sessions attended.  
Smartphone Application Usage, including: total 
number of mood log entries; surveys completed; 
journal entries; goals completed; 
views/downloads of resource material and 
BEACON button presses. 
Whether or not each site implemented other 
hospital-based suicide reduction measures 
during the study intervention period. 
Structured qualitative interviews (to assess 
barriers, facilitators and suggestions for 
improvement) 
Interview participants regarding what helped 
and what did not help, the effect of the 
intervention on help seeking behaviours, 
assessments, the application. 

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A major difficulty in all clinical trials is ensuring that patients attend their baseline 
appointment. As such, a key component to our patient recruitment strategy is to ensure 
minimal loss to follow-ups between the point of referral and study enrollment. Delegated 
study staff will develop an ongoing relationship with clinical staff to encourage referrals to be 
provided as soon as possible. Delegated study staff will aim to contact potential participants 
within two business days of the referral.  
 
Once enrolled in the study, PST sessions will be scheduled as per patient preference 
with the Research Therapist and standard lost to follow-up procedures will be followed for 
patients who do not complete their next scheduled follow-up appointment. This is an 
escalated response which may include any combination of the following: continued attempts 
to contact the participant by postal mail, telephone and/or email, contacting a participant’s 
emergency contact and contacting a participant’s family physician. An additional 12-week 
follow-up visit has been included to minimize attrition between 6 weeks and 24 weeks. 
 
The BEACON Suicide Prevention smartphone application will also be designed to 
increase participant engagement with the study. For instance, participants will have “instant” 
and time-delayed communication with their Research Therapist through the messaging 
feature of the mobile application. Research Therapists will also have access to a Clinician 
Dashboard which will allow them to identify patterns of use which might indicate that a 
participant may at risk of being lost to follow-up (i.e. through decreased use of the 
smartphone application). This will provide Research Therapists with an opportunity to reach 
out to participants and attempt to re-engage them in the intervention. Research Therapists 
will monitor the dashboard, including connect features during regular business hours, as 
outlined with each participant at their first visit. 
4.3.2. Data Management 
 
Electronic Data Capture System 
All data will be entered electronically using a username and password-protected 
electronic data capture system (EDCS) at each site. The BEACON web-app is designed and 
coded using Microsoft Visual Studio .NET 2015 and JQuery/Java scripts. The back-end 
database is designed and configured using the validated MS SQL Server 2008 R2. The 
Ottawa Method Centre-Data Management Services (OMC DMS) uses the Agile 
Methodology for software development. All network, server security and privacy settings are 
regularly tested and comply with Health Canada recommendations and Good Clinical 
Practice (GCP) for secured data management services. The BEACON EDCS is hosted on a 
physical server, not in the cloud, that is located at The Ottawa Hospital (TOH) data centre in 
a secure server room with limited access to authorized personnel behind lock doors. The 
web/database server is behind the TOH firewalls. The OHRI web site is secured with the 
highest rating from Entrust SSL virtual test. The data transfer between the client and server is 
protected with Entrust SSL 256-bit encryption. All data transfers between the client 
computers/browsers and the server/database are encrypted via https. The BEACON EDCS 
does not collect/retain any personal health identifier (PHI) or personal identifying 
information (PII). If PHI or PII is inappropriately entered into the EDCS in error, it cannot be 
removed at the site level. The site must notify OMC DMS to remove the information. 
Paper Data Collection 
The following information will be entered into the EDCS: all study outcome 

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questionnaires, concomitant medications, and the adverse event log. The BSS, SPSI-R:S, 
adverse event log and concomitant medication will be completed on paper and entered into 
the EDCS by site delegated study staff. If visits occur via videoconference methods, the 
questionnaire may be completed using screen sharing or an interview format. All paper-based 
data collection will be saved by delegated study staff members at each site on the secure 
hospital server. On a monthly basis, each site will send their de-identified study data 
(password protected and encrypted) to the Research Coordinator via email as per N2 
Standard Operating Procedure 016 File Transfer and its associated OHRI Addendum. This 
data will then be imported into the study master database in SPSS. This database will be 
stored on the OHRI hospital server at the Coordinating Site and only the TMC will have 
access to it.  
All hardcopies of original study documentation will be stored in the participant 
research charts which will be categorized in numerical order, according to sequential 
numbering (i.e. 001 to 350). Once all data monitoring, validation and cleaning activities are 
complete, these records will be archived at a secure storage facility for a period of ten years, 
as required by ICH GCP. 
4.3.3. Statistical Methods 
 
Categorical participant characteristics, such as gender identity, marital status and 
education level will be reported using descriptive statistics, using frequencies and 
percentages. Continuous characteristics, such as age, will be reported using mean ±SD for 
continuous variables that are normally distributed and as median and 25th and 75th 
percentiles for non-normally distributed variables. Non-normally distributed variables will 
also be dichotomized and analyzed as categorical data, as described above. Changes in 
participants’ scores from their baseline visit to follow up at one year will be by repeated 
measures ANOVA with generalized linear mixed modelling (GLMM) to account for missing 
variables. Multivariate linear regression analyses will be performed to determine which 
participant characteristics moderate primary and secondary treatment outcomes.  
 
Additional subgroup analyses will be carried out to determine the impact of 
smartphone-assisted PST for the following subgroups: first time presentations of self-harm 
compared to repeaters; Francophone versus Anglophone; men with substance abuse disorders 
versus no substance abuse disorder; and rural versus urban residence. 
 
We will also conduct a process evaluation to explore the implementation, receipt and 
context of the intervention with a view to helping understand the results in accordance with 
the Medical Research Council’s guidelines on assessing complex interventions [77]. This will 
describe the processes of the intervention group, provide information about the contexts in 
which the treatments are delivered and supply information about the experience of being part 
of the trial. This will also include an exploration of the uptake of the intervention at various 
sites, including subgroup analyses of the number of face-to-face sessions completed as well 
as the extent to which participants used the smartphone application 
Missing Data 
 
The analysis of the primary outcome will be based on self-report data collected 
through the BEACON Suicide Prevention Smartphone Application. As such, the 

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completeness of the data will be impacted by participant withdrawals. In order to minimize 
the impact of participant drop out, withdrawal and those who are lost to follow-up, the 
research team will follow-up with participants regarding the completion of the study 
questionnaires at their PST appointments. The smartphone application will also be used to 
prompt and remind participants to complete the study questionnaires. Should participants be 
lost to follow-up, a delegated study staff member will follow-up with them directly to 
complete the questionnaires either by telephone or by mail. Where possible, a delegated study 
staff member will attempt to ascertain the reasons for drop out or withdrawal from 
participants in order to address any issues within the research team’s control in order to 
prevent future study withdrawals.  
 
As such, it is possible that there may be missing data. Characteristics of participants 
with missing data will be compared to those of participants with complete data to examine 
the assumption of Missing at Random. In the case of substantial missingness (e.g., >5%), 
missing outcomes will be imputed using multiple imputation prior to analysis. 
 
4.4. Monitoring  
 
4.4.1. Data Monitoring 
 
An independent Data and Safety Monitoring Committee (DSMC) has been convened 
to assess the progress of the clinical trial, the integrity of the data, the safety of all 
participants and to provide recommendations to the Principal Investigators.  The members of 
the DSMC serve in an individual capacity and provide their expertise and recommendations.  
The DSMC will review cumulative study data to evaluate safety, study conduct, and 
scientific validity and data integrity of the study. The general responsibilities of the DSMC 
are: 
• To evaluate, on an ongoing basis, the accumulating safety assessments to 
ensure the ongoing safety of study participants; 
• To consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an 
impact on the safety of the participants or the ethics of the study; 
• To review the conduct of the study, including protocol violations and 
deviations; 
• To review data on participant recruitment, accrual, and retention, as well as 
assessments of data quality, completeness, timeliness, data retention, data 
storage, data transmission and data access; 
• DSMC members will review Adverse Events (AEs) and Serious Adverse 
Events (SAEs); and 
• To make recommendations to continue, modify, or terminate the study. 
 
4.4.2. Harms 
 
In this clinical trial, an Adverse Event (AE) will be defined as any untoward medical 
occurrence which may or may not be related to the study intervention. This includes 
unfavourable changes in symptoms, signs, or health conditions. AEs will be collected by 

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study staff at each study time point from the point of consent until the end of a participant’s 
involvement in the study (due to withdrawal, discontinuation, or study completion). If a 
participant reports an AE after the point of consent but prior to receiving the study 
intervention, this AE will be categorized as unrelated to the study treatment.  
All AEs will be reviewed and classified by the site co-Principal Investigator, at 
his/her discretion. Investigators will determine relatedness of an event to the study 
intervention based on a temporal relationship to the study intervention, as well as whether the 
event is unexpected or unexplained given the participant’s clinical course, previous medical 
conditions/history, and concomitant medications or interventions. 
In this clinical trial, a Serious Adverse Event (SAE) will be defined as any untoward 
medical occurrence that meets one of the following criteria: results in death; is life 
threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in 
persistent or significant disability/incapacity; or, causes a congenital anomaly/birth defect. 
All AEs that meet the criteria for an SAE will be reported to the Coordinating Study Site, 
DSMC and REB within seven (7) days of their occurrence. All subsequent suicidal behaviour 
will be treated as an SAE and will be monitored, investigated and tracked by the research 
team. A file will be kept by delegated study staff members in which all SAEs will recorded. 
A participant’s physician and/or other specialists will also be contacted to advise them of 
their patient’s participation in the study (with consent) and in the case of a Serious Adverse 
Event (SAE). 
The following occurrences will be routinely collected and assessed by delegated study 
staff members: 
• Death by suicide; 
• Subsequent self-harm; 
• Visits to the Emergency Department or other unscheduled hospitalizations; 
and, 
• Re-presentations to the Emergency Department for self-harm. 
After Session 6 of the face-to-fact PST, study participants will be classified as 
“passive participants” within the BEACON smartphone application. That is, while they are 
no longer receiving routine follow-up from study staff, they will still be considered study 
participants and will have access to all the resources housed within the smartphone 
application. This will occur between Session 6 (final PST session) and Session 7 (6 
month/End of Study). During this time, participants will receive automated safety monitoring 
through the BEACON smartphone application. If participants find themselves in a mental 
health crisis and select the “BEACON” feature, they will be prompted to connect with one of 
the following: emergency services via 911, a local mental health crisis line or one of their 
listed emergency contacts. Through the Clinician Dashboard, their Research Therapist will 
also be notified that they have enacted the “BEACON” feature. The Research Therapist will 
then follow-up with the participant in order to ensure their ongoing safety and document any 
required AE or SAE information.  
4.4.3. Study Monitoring 
 

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A site initiation meeting/videoconference will be conducted once the site has received 
all regulatory and REB approvals, but before recruitment has begun. All study team members 
for this site will attend in addition to the Research Coordinator, Principal Investigator and co-
Principal Investigator for the trial. The Principal Investigator and Research Coordinator will 
conduct site initiation and will cover the items listed below in order to ensure that all study 
staff are aware of their delegated duties: 
• Study Protocol;  
• Study-specific SOPs; 
• Complete review of Baseline Appointment and follow-up appointment 
documentation; 
• ICH-GCP compliance;  
• Adverse Event and Serious Adverse Event recording and reporting; 
• Protocol deviation and violation management; 
• Internal study monitoring procedures and requirements; and 
• Delegated study staff responsibilities (including site co-Principal Investigator). 
The Principal Investigator, or appropriate delegate, will generate a brief report on the material 
covered and any additional training required. The Principal Investigator, or appropriate 
delegate will forward the report to the site for review and sign-off no later than 10 business 
days from site initiation. Once the site initiation visit is complete, an internal monitor will be 
selected. This monitor will not be involved in data collection activities and will be one-step 
removed from the clinical trial.  
The internal monitor will perform the first monitoring visit at each site shortly after 
the site has recruited their first participant to ensure that research personnel have 
implemented the appropriate recruitment processes and procedures, such as eligibility sign-
off and consent. This visit will be completed prior to the site recruiting more participants. 
Any corrective actions implemented in regards to inconsistencies identified during the 
previous monitoring visits will be assessed for completeness. Based on the research category 
and participant/institute risk exposure, remote monitoring visits will occur every month after 
the first monitoring visit. The internal monitor may schedule more visits or on-site visits as 
needed. 
During the remote monitoring visit(s), the monitor will perform the following source 
document verification and study master file review:  
 
• 25% of patients’ Informed Consent Forms (ICFs) and Eligibility Criteria; 
• 25% of the Adverse Events and all Serious Adverse Events that have been 
reported since the previous monitoring visit will be reviewed and verified; 
• 25% of protocol-related endpoints will be assessed for all applicable 
participants; 
• 15% of patients’ charts will be audited for accuracy and completeness; 
• All training documentation/records and delegation log; 
• All regulatory documentation including REB approvals/amendments (stored at 
coordinating site). 

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If the monitor notices a large number of discrepancies during the visit, they may perform 
additional verification of source documents and/or internal monitoring visits as needed. 
The monitor will also conduct close-out procedures once the last enrolled participant 
has completed his/her final study visit. During close-out, the monitor will perform the 
following tasks: 
• Ensure the completion of outstanding charting documents; 
• Ensure all previous monitoring corrections have been addressed; 
• Collect outstanding patient data forms and study forms such as the screening 
and enrolment logs; 
• Perform a final review of the study file documents; 
• Review the plans for record retention; 
• Ensure all Adverse Events and Serious Adverse Events have been reported 
appropriately; and 
• Ensure that the local REB has been notified of the site closure. 
The monitor will prepare the final monitoring report and send it to the site for their records. 
The site will address all monitoring observations (including observations from previous 
monitoring reports) prior to final study closeout. 
5. ETHICS AND DISSEMINATION 
 
5.1. Research Ethics Approval 
 
A pilot study was conducted for this study over a period of nine months from 
September 2016 to June 2017 that evaluated the acceptability and feasibility of using a beta 
version of smartphone-assisted problem-solving therapy with seven men who presented to the 
Emergency Department with intentional self-harm. A key goal of this study was to evaluate 
the process of using a smartphone application in conjunction with face-to-face 
psychotherapy. This study was reviewed and approved by the Ottawa Hospital Health 
Science Network Research Ethics Board (OHSN-REB Protocol # 20150765-01H). Through 
this REB review, the research team was able to solve a number of issues relating to data 
confidentiality and participant privacy which have been incorporated into the design of the 
BEACON Suicide Prevention Smartphone Application. Trial design and conduct has been 
informed by Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 
(TCPS 2) and Good Clinical Practice (GCP), an international ethical and scientific quality 
standard for designing, conducting, recording and reporting trials that involve the 
participation of human subjects. Compliance with these standards provides public assurance 
that the rights, safety and well-being of trial subjects are protected, consistent with the 
principles that have their origin in the Declaration of Helsinki, and that clinical trial data are 
credible. This study protocol and the attached Informed Consent Forms (refer to Appendix B) 
will be reviewed and approved by the REB of Record, as assigned by Clinical Trials Ontario 
(CTO), and any other local Research Ethics Board (REB) required by participating sites. 
Subsequent to initial review, the Principal Investigator will complete annual progress reports, 
to be submitted to the REB annually, which will describe the progress of the trial, including 
recruitment and follow-up rates, participant safety and any changes to the study protocol 
and/or Informed Consent Forms. 

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This study protocol will be registered with clinicaltrials.gov.  
 
5.2. Protocol Amendments 
Any subsequent modifications to the study protocol, including changes to study 
objectives, study design, patient population, sample sizes, study procedures, or significant 
administrative changes will be agreed upon by the Steering Committee and submitted to the 
REB for review and approval prior to implementation. Any modifications or new information 
that may impact a participant’s willingness to participate in the study will be relayed to 
participant’s as soon as possible and they will be asked to sign a Consent Update Form, as 
approved by the REB. 
5.3. Consent 
 
5.3.1. Informed Consent 
 Staff at the intervention sites, including psychiatrists, residents, , nurses and/or other 
clinical staff will approach patients with information about the study. To avoid coercion and 
overburdening of staff, they will be not be responsible for any consent-related tasks. If the 
patient is interested in participating in the study, staff will obtain consent for a research staff 
member to contact them. The delegated research staff will then contact the patient to provide 
further information about the study, answer any questions and schedule a consent visit.  
 
At the consent visit, a delegated study staff member will provide the patient with 
additional information about the study and confirm their interest in participating. Once this is 
complete, the delegated study staff member will conduct an informed consent discussion with 
the patient, in accordance with ICH GCP regulations, and the patient will have an opportunity 
to ask any study-related questions prior to signing the consent form. Consent visits may occur 
using videoconference platforms, including MS Teams, Zoom for Healthcare, Zoom in Epic 
and OTN. Written consent will also be accepted as an electronic signature, including scan 
and email or digital signature. Once written informed consent has been obtained, the 
delegated study staff member will schedule the Baseline Visit as detailed in this study 
protocol. While all versions of the consent form will be standardized, they will be edited to 
include appropriate language and letterhead, as dictated by each study site’s local regulations. 
The consent forms will be translated into French and Oji Cree (as appropriate).  
5.3.2. Ancillary Studies 
If this protocol is amended to include any ancillary studies, upon approval of the 
REB, all participants involved in these ancillary studies will be asked to sign a Consent 
Update Form. If a separate Informed Consent Form is required, a copy of the consent form 
will be stored with the BEACON Study consent documentation. Copies of all REB approvals 
for the ancillary studies will be stored at the Coordinating Study Site. A data file tracking all 
signed ancillary consent forms must be maintained by the ancillary study and provided to the 
Clinical Research Coordinator of the BEACON Study. 
5.4. Confidentiality 

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All study-related documentation will be double-locked in areas with limited access at 
the appropriate study site. For virtual visits, electronic documents may be completed and 
stored on the study-specific SharePoint. Study documents should be password protected and a 
log kept separately from the documents so that access to the files is not lost. Electronic 
documents should not be stored on mobile devices (such as a USB or directly on a laptop). 
All participants will be assigned a unique participant identification number, which will 
appear on all documentation included in a participant’s research chart, including study forms, 
questionnaires, participant progress notes and correspondence in order to maintain participant 
confidentiality. All correspondence with participants’ will be de-identified in order to remove 
names and other potentially identifying information prior to being included in the study chart. 
All documentation, including signed Informed Consent Forms, the participant information 
form and messaging logs will be stored in double-locked filing cabinets in areas with limited 
access and stored separately for participant research charts to avoid linking a participant’s 
name and unique identification number. 
 
Each study site will have a separate Master Tracking Log which will link participants’ 
names and identification numbers. These will be password-protected and only delegated 
research staff at that site will have access to it. Participant information will be stored on the 
secured hospital servers at each study site. The password-protected documents containing 
participant study data will be transferred to the coordinating study site by email, as per N2 
and OHRI guidelines. Data entered into the EDCS is stored on the OHRI secure server. Study 
staff are all provided unique username and password combinations. The EDCS will not 
capture or store any identifiable information. All data is encrypted at rest as well as in transit. 
Participants’ study information will not be released unless a delegated study staff member 
obtains written permission from the participant or where required by law. Participants will 
not be identified in study presentations or publications. All participant records will be kept 
for a period of ten years, as indicated in the ICH GCP guidelines. 
5.5. Declaration of Interests 
The study Investigators have the following interests to declare: 
1. Dr. Sakina Rizvi: 
• Is a co-Investigator with the Canadian Biomarker Integration Network in 
Depression (CAN-BIND), funded by the Ontario Brain Institute (OBI). She 
also received research grant funding from Pfizer Canada.  
5.6. Access to Data 
The Coordinating Study Site will be responsible for the sharing of data between study 
Investigators. Upon request, all Investigators will be provided with cleaned copies of the 
study datasets (please refer to Section 5.8.3 “Reproducible Research” regarding the sharing 
of data). All trial data will be stored on the OHRI secured server at the Coordinating Study 
Site and will be password-protected. Site co-Principal Investigators will have direct access to 
data collected from their site and may obtain access to the data from other sites upon request 
(refer to Section 5.8.3 “Reproducible Research” regarding the sharing of data). In order to 
protect participant confidentiality, all potentially identifying information will be removed 
from the datasets prior to intra-study sharing.  

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5.7. Ancillary and Post-Trial Care 
In the event of a study-related injury or illness, participants will be provided with 
appropriate medical treatment and care. Financial compensation for lost wages, disability or 
discomfort due to an injury or illness is not generally available.   
5.8. Dissemination Policy 
 
5.8.1. Trial Results 
 
Data Analysis and Release of Results 
To protect the scientific integrity of this study, data from all sites will be analyzed and 
reported together. While sub-analyses with specific groups will be conducted, no centre is 
expected to report data collected from their centre alone. The primary data analysis will be 
conducted by the Ottawa Methods Centre (OMC) at OHRI in conjunction with ICES. All 
study publications and presentations are expected to adhere to the BEACON Study objectives 
as detailed in this protocol. 
Review Process 
A Publications Committee, a subcommittee of the Steering Committee, will be 
established to coordinate all study publications and presentations. All presentation and 
publication abstracts must be submitted for review by the Publications Committee. This 
committee will create a running list of all potential publications, review all abstracts 
submitted for publication by the Investigative Team, identify a lead author for each 
publication, review all publication manuscripts and submit publications to peer-reviewed 
journals for publication. They will also ensure that all publication guidelines and regulations 
are respected, including adherence to the study’s objectives and CONSORT statement for 
cluster RCTs. 
Each presentation or publication abstract/manuscript must be submitted to the 
Research Coordinator prior to each Publications Committee Meeting. The abstracts will be 
reviewed at the subsequent Publications Committee meeting. All members will vote on each 
abstract and will provide feedback. The Research Coordinator will include all feedback in the 
meeting minutes and, after each meeting, and will circulate all feedback appropriately. 
Authors will be expected to review the committee’s feedback and re-submit their final 
abstract or manuscript for final approval by the Publications Committee. 
Primary Outcome Publications 
 
The Publications Committee will ensure that no presentation or publication 
undermines the dissemination of any primary outcomes publications. Primary outcomes 
publications refer to any presentation or publication that presents data on the primary 
outcome measure as detailed in this protocol. During the review process, the Publications 
Committee will determine if an abstract/manuscript will undermine any primary outcome 
publications. If it is determined that this is the case, the author will be asked to delay 
publication until such a time as the primary outcome publication is released. 

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Other Study Papers, Abstracts and Presentations 
 
This refers to all presentations and publications that do not report on the primary 
outcome of this trial, as detailed in this protocol. All presentation and publications 
abstracts/manuscripts must be reviewed and approved by the Publications Committee prior to 
submission.  
Close-Out Procedures 
 
The primary outcome publication is expected to be submitted for publication within 
two years of the completion of follow-up date collected (i.e. after the last study participant 
has completed the study). However, this may occur at an earlier or later date if the 
circumstances warrant. Study close-out will occur in two stages: 
• Period of analysis and documentation of primary outcome results; and 
• Debriefing of participants and dissemination of all other study results. 
Reporting of Study Results 
 
All study results will be released to study participants, referring clinicians, patients 
and the general medical community. Results will be communicated to study participants 
through the use of a newsletter or presentation, as per the overall preference of the 
participants. Other forms of dissemination include: academic publications, conference 
presentations and presentations to the general public. 
5.8.2. Authorship 
 
Authorship guidelines to be followed for this trial have been adapted from the OHRI 
Authorship Guidelines for Researchers and criteria recommended by the International 
Committee of Medical Journal Editors (ICMJE). 
 
Qualification for Authorship 
 
Whether or not investigators and/or research staff members are eligible for authorship 
credit will be determined using the following ICMJE criteria: 
 
1. Substantial contributions to the conception or design of the work; or the acquisition, 
analysis, or interpretation of data for the work; AND 
 
2. Drafting the work or revising it critically for important intellectual content; AND 
3. Final approval of the version to be published; AND 
4. Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved. 
 
Anyone who qualifies for authorship, based on the above, should be listed, including 
research staff, consultants, trainees and students. Those who do not meet all four of the above 
criteria should be acknowledged (refer to Acknowledgements”).  These criteria are not 
intended to be used as a means of disqualifying study Investigators from authorship. Anyone 

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who meets the first criterion will be given the opportunity to participate in the review, 
drafting, and final approval of the manuscript. 
 
Author’s Contribution 
Prior to the launch of the study, co-authors that are responsible for the various aspects 
of the trial will be identified. Author contributions will be determined using the Contributor 
Roles Taxonomy (CRediT), a high-level classification system which includes 14 possible 
contributor roles. Some journals require that information is published about the relative 
contributions of each author on the manuscript. Where this is not a requirement of the 
journal, if possible, this information will be provided in the acknowledgements section of the 
manuscript. Since authorship itself does not specify the relative contributions of each author, 
a brief author contribution statement will be included in order to resolve any potential 
ambiguity surrounding contributions. 
 
Order of Authorship 
 
For this trial, order of authorship will be determined by contribution: the person who 
took the lead in writing the manuscript or doing the research will be listed first and the most 
experienced contributor will be listed last. All other co-authors will be listed alphabetically.  
 
In order to avoid any disputes as to the order of authorship, the following precautions 
will be taken: 
 
1. The authors will decide on authorship and authorship order together, prior to drafting 
their manuscript; and 
2. Authors should specify in their manuscript a description of the contributions of each 
author so that readers can interpret their roles correctly. 
 
Acknowledgments 
All those who have made a contribution to the work, but who do not fulfil the criteria 
for authorship (noted above in the “Qualification for Authorship” section), should be 
acknowledged by name in the manuscripts acknowledgement section. Authors should request 
permission before acknowledging anyone. Examples of individuals who may be appropriate 
to acknowledge include: those responsible for general supervision of a research group, or 
those who provided administrative, clinical or technical support. 
 
5.8.3. Reproducible Research 
The Coordinating Study Site will be responsible for the sharing of data between study 
Investigators. The Principal Investigator and co-Principal Investigator will maintain exclusive 
access to the data for two years post-study closeout. After which the data will be available to 
the wider study team for sub-analyses for a period of 3 years. At 5 years post-study closeout, 
de-identified study data will be published in an online repository and become publically 
available. 

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6. APPENDICES 
 
6.1. Appendix A – Completion Time Required for All Outcome Measures included in Study 
 
Domain 
Measure 
Purpose of 
Measure 
Time Needed to 
Complete Measure 
Baseline & 
Session 1 
 
During Study 
Intervention 
6 Week 
Follow-Up 
Post-Study 3 
month and 12 
month 
Demographics 
Demographic Questionnaire 
Descriptive 
Statistics/ 
Covariates 
3-5 min. 
X 
 
 
 
Media 
Influence of the Media Questionnaire 
Covariate 
3-5 min. 
X 
 
 
 
Masculinity 
CMNI 
Covariate 
5-10 min. 
X 
 
 
 
Suicidality 
BSS 
Primary 
Outcome 
5-10 min. 
X 
 
X 
X 
Depression 
PHQ-9 
Secondary 
Outcome 
5-10 min. 
X 
 
X 
X 
Anxiety 
GAD-7 
Secondary 
Outcome 
5-10 min. 
X 
 
X 
X 
PTSD 
PC-PTSD-5 
Secondary 
Outcome 
3-5 min. 
X 
 
X 
X 
Health-Related Quality of 
Life 
EQ-5D 
Secondary 
Outcome 
3-5 min. 
X 
 
X 
X 
Meaning in Life 
Experienced Meaning in Life Scale 
Secondary 
Outcome 
5-10 min. 
X 
 
X 
X 
Social Support 
Multidimensional Scale of Perceived Social 
Support 
Secondary 
Outcome 
5-10 min. 
 
X 
 
X 
X 
Alcohol Misuse 
AUDIT-C 
Covariate 
2-3 min. 
X 
 
X 
X 
Alcohol Misuse 
AUDIT* 
*Only to be administered in the event of a 
positive screen on the AUDIT_C 
Covariate 
3-5 min. 
X 
 
X 
X 
Drug Misuse 
DAST-10 
Covariate 
3-5 min. 
X 
 
X 
X 
Costs 
TiC-P 
Secondary 
Outcome 
5-10 min 
X 
 
X 
X 
Problem-Solving Skills 
SPSI-R:S 
Secondary 
Outcome 
5-10 min. 
X 
 
X 
X 
Health service use data* 
 
*Collected from ICES 
databases 
• 
Previous hospitalizations for self-harm 
(NACRS); 
Secondary 
Outcome 
N/A 
 
 
 
X 
 
 
X 

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• 
Presentation to hospital for self-harm 
(NACRS); 
• 
Presentations to hospital for any reason 
other than self-harm (NACRS); 
• 
Admission to hospital for any reason 
(OHIP); 
• 
Outpatient appointment for any reason 
(OHIP); 
• 
Primary care visits (OHIP). 
Estimated Total Completion Time (in Minutes) 
60-113 
18-35 
33-60 
49-93 
 
6.2. Appendix B- List of Study Sites 
• Kingston General Hospital, Kingston, ON; 
• London Health Sciences Centre (Victoria Hospital Site), London, ON; 
• Unity Health, St. Michael’s Hospital, Toronto, ON; 
• Sunnybrook Health Sciences Centre, Toronto, ON; 
• The Ottawa Hospital, Ottawa, ON. 

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