Pilot Study of a Smart Phone Assisted Problem Solving Therapy for Men Who Have Presented With Intentional Self-harm to Emergency Departments
Phase: NA
Conditions: Suicide
Sponsor: University of Ottawa

Dr. Simon Hatcher – OSSU Pilot Study – Protocol  
 
 
 
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Protocol for a pilot study of a smart phone assisted problem solving therapy for men 
who have presented with intentional self-harm to emergency departments 
 
1.0 BACKGROUND AND RATIONALE 
We define self-harm as intentional self-poisoning or self-injury; whether or not there is 
evidence that the act was intended to result in death. In the past the term used was 
‘attempted suicide’; however, peoples’ motives for harming themselves are highly 
variable. A person may have more than one motive and motivation is hard to assess. In 
line with usual public policy in health and social care, we use the term ‘self-harm’ 
describing a behaviour – avoiding the word ‘deliberate’ because many service users or 
consumers dislike its connotations.  
In Ontario, the number of people who present to hospital Emergency Departments with 
self-harm is difficult to accurately assess, but the best estimate is about 30,000 each year 
[1]. The most common form of self-harm seen in Emergency Departments (around 80% 
of episodes) is the intentional consumption of an excess of a medicinal or toxic product, 
whether or not there is evidence that the act was intended to result in death. Injuries, most 
commonly self-cutting, form 15-20% of episodes [2].  
Two-thirds of people attending Emergency Departments because of self-harm are under 
35 years of age. They are high users of health and social care services. Self-harm has a 
strong association with suicide: 7 patients per 1000 (about 1%)  die by suicide in the year 
after attending Emergency Departments with a non-fatal episode (60 times the general 
population risk), rising to as many as 30 patients per 1000 over the next 15 years [3]. In a 
recent longitudinal study conducted at the University of Toronto, “all-cause mortality 
following a first episode of self-poisoning was 1107 per 100,000 person-years… [with] 
nearly half of all deaths being suicides, accidents or undetermined intent.” [4] About a 
quarter of suicides are preceded by a hospital visit due to non-fatal self-harm in the 
previous year [5]. It is the major identifiable risk factor for suicide. Mortality from non-
suicidal causes is also high, with significantly more than the expected numbers of deaths 
from natural causes and from accidents [6]. Whilst four of ten people who present with 
self-harm are men, they form nearly two thirds of suicides after an episode and are far 
more likely than women to die of premature death from other causes. [6] The premature 
deaths are greatly over-represented among young people and the life years lost to the 
community are many.  
Repetition of non-fatal self-harm stands at around 20% annually [3] and is associated 
with much distress and many unresolved interpersonal problems. It is likely that any 
reduction in repetition of self-harm will be mirrored by a fall in subsequent suicides. The 
Canadian Association for Suicide Prevention blueprint for a National Suicide Prevention 

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Strategy has identified those who have presented to hospital with non-fatal self-harm as a 
high risk target group to reduce suicide.  
People attending Emergency Departments after self-harm receive a variable standard of 
care in Ontario. Many are not assessed for psychological needs, and the little 
psychological therapy available is not usually covered by OHIP. Local data from 
hospitals in Ottawa show that only 4 out of 10 men who present with intentional self-
harm are seen by a mental health professional. Few are offered an evidence-based 
treatment aimed at reducing their risk of suicide or repeated self-harm. At present, 
assessment for self-harm in adults in Ontario is highly variable and there is no standard 
protocol for therapy. Assessment of suicide risk is currently a Required Operating 
Practice for Canadian Hospital accreditation; however, individuals identified as at-risk 
for suicide rarely receive recommended care [7].  
Specialist services offer intensive and lengthy treatment for the minority of people who 
self-harm diagnosed with personality disorders, such as dialectical behavior therapy or 
mindfulness based therapy. The evidence for the effectiveness of these specialist 
therapies comes almost entirely from studies in women. 
There have been more than 50 randomized controlled trials (RCT’s) in self-harm, mostly 
based on a psychological therapy, on alterations to the administration of care or a 
combination of these approaches. The published Cochrane review on intervention 
following self-harm is 15 years old and found only small and methodologically poor 
trials; although, small trials of problem-solving therapy suggested benefit and concluded 
that "larger trials are badly needed." [8] A US review of international literature [9] judged 
trials to be limited by lack of power; although, "trends suggested incremental benefits 
from some interventions (in particular, problem-solving therapy for patients aged 15 or 
older)." 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 
2013) found little that is likely to help with routine practice [10]. An alternative to 
developing new interventions is to optimize treatment as usual, which usually consists of 
referral for psychiatric or psychological help as well as other health or non-health 
services. However, neither a systematic review nor a large multicentre study has found a 
clear relation between the nature and intensity of standard hospital care and subsequent 
fatal or non-fatal repetition of self-harm [11].  The recent NICE guideline on self-harm 
stated that "no conclusions could be made regarding psychosocial interventions for 
reducing repetitions of self-harm," although there was sufficient evidence to recommend 
“a well conducted RCT.”   
Dr. Hatcher has published two such large randomized controlled trials comparing 
problem solving therapy to usual care in New Zealand. The first study found that in 
people who were presenting with repeat episodes of self-harm to hospital, problem 
solving therapy decreased the rate of repetition by about a third [12]. The second study 

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failed to replicate this finding, but the dose (number and length of sessions) of problem 
solving therapy was lower than the first trial. Both patients and therapists commented that 
a longer therapy with some booster sessions may be helpful [13]. A third trial in Maori 
(the indigenous people of New Zealand) found that when added to problem solving 
therapy, a focus on “sense of belonging” resulted in significantly fewer contacts with 
Emergency Departments in the year after self-harm compared to usual care [14]. 
We have received funding for a multicentre cluster randomized trial from the Ontario 
SPOR support unit (funded by CIHR and the Ontario Ministries of Health and Research 
and Innovation) comparing the delivery of smart phone assisted problem solving therapy 
with treatment as usual in men who present with self-harm. The rationale for focusing on 
men is that most suicides are in men and previous trials have found that providing generic 
treatments to everyone does not work. The intervention we will offer builds on previous 
work by trying to extend the range and intensity of therapy. We will do this by 
supplementing it with a sophisticated smartphone application that has already 
demonstrated its effectiveness in men with substance abuse disorders. We will be 
offering an intervention specifically designed for men who self-harm, as they are hard to 
engage and are more likely than women to have substance abuse problems. However, 
before proceeding with the full trial, we would like to carry out a pilot study. The purpose 
of this is to refine the intervention and treatment manual, as well as test the acceptability 
and feasibility of the intervention to clinicians and patients. 
2.0 OBJECTIVE 
The pilot study has three aims. The first is to refine a novel intervention using a 
combination of a smartphone application with best practice psychotherapy for men who 
have presented to hospital with intentional self-harm. The outcome will be the generation 
of a revised treatment manual for problem solving therapy that incorporates the use of a 
smartphone application.  
The second aim is to test the intervention’s acceptability and practical usability. We will 
ask clinicians and patients about the acceptability of the intervention and the acceptability 
of using routine data sources as outcome measures. This will inform methods of 
recruitment for the larger cluster randomized controlled trial.  
The last objective is to assess feasibility of recruitment. To test this we aim to recruit at 
least half of the men the study team ask to take part in the pilot study. To test feasibility 
in referring clinicians, our aim is that at least half of men who present with intentional 
self-harm to the Psychiatric Emergency Services will be approached and have the TOH 
form allowing contact details to be passed on to researchers completed.   
 
 

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3.0 METHODS 
3.1 Participants and Settings: 
The participants will be ten English speaking men (aged 18 and over) who present via the 
Emergency Department (this usually involves the Psychiatric Emergency Services) of 
The Ottawa Hospital General and Civic Campuses with intentional self-harm. Men must 
be English speaking, as questionnaires, data collection tools, cognitive and/or 
psychological tests have only been validated in English. These materials have not yet 
been translated into French. This pilot will inform a larger scale randomized controlled 
trial, which will be translated into validated French material by CHESS Mobile Health 
Inc.  
Participating men will have to have access to a smartphone and a data plan. In the full 
trial, we plan to offer up to 100 participants smartphones with data plans if they do not 
own a smartphone. Moreover, participants will be excluded from participating in the pilot 
if they:  have cognitive impairments which render them incapable of using a smartphone; 
are unwilling to return to The Ottawa Hospital General Campus for follow-up 
appointments; are unwilling to use a smartphone application to facilitate the treatment of 
self-harm; or in the opinion of the investigator, they are unwilling to consent and are 
incapable of committing to a 3 month long study. 
3.2 Interventions: 
The intervention will be a face-to-face psychotherapy based on problem solving therapy 
combined with a smartphone application, namely CHESS Mobile Health. The problem 
solving therapy will be offered for six weekly sessions. The intervention will be delivered 
by Dr. Hatcher, a staff psychiatrist in Consultation-Liaison Psychiatry at The Ottawa 
Hospital General Campus. This therapy is recommended by NICE for the management of 
people after self-harm and has been used by Dr. Hatcher in previous randomized trials of 
treatment in this population and is the standard of care for this population. A description 
of the therapy and training materials can be found here, 
www.problemsolvingtherapy@ac.nz.  The face-to-face therapy will be supplemented by 
the CHESS Mobile Health program (http://www.chessmobilehealth.com)  a mobile 
application which has been tested in a randomized controlled trial in male Veterans in the 
USA [15] and found to be effective in reducing harmful substance use. The main 
interface (see Figure) allows for users to Gather, Connect, Discover, and Plan as well as 
issue an alert when the user is at a high risk of self-harm or suicide.   
 The Gather interface provides users with a social network of supporters. (Supports 
do not need to have the CHESS Mobile Health application). From here, users can 
create a personalized profile as well as view My Support Team profiles.  
 Through the Connect interface, users can message individual members.  

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 The Discover interface allows users to keep motivated through a variety of 
methods. Feedback from our team members with lived experience informs us that 
this is important for the target population.   
 The purpose of the Plan interface is to document the progress of the user and to 
link with the face-to-face therapy.  
- 
A daily check-in is prompted to the service user to assess their state of well-
being.   
- 
From a central dashboard, clinicians can view their caseload of users’ progress 
and upload custom surveys.  
- 
The user can also program high-risk zones through the application’s GPS. For 
instance, if a user is likely to binge drink at a specific bar, they can program 
said bar as a high risk area and a push notification will be sent to the patient 
when they are within 100 meters of the bar.  
- 
The link with the face to face therapy is that users will be able to assess their 
problem solving style, generate problem lists, define problems, set goals and 
monitor progress using the application. Previously this was done using pen 
and paper. 
 Upon selecting “Beacon,” an emergency notification is immediately distributed to 
alert members of the user’s Support Team. 

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All participants in the study will have full access to the usual mental health services 
available in Ottawa. This includes in-patient admission, referral to specialist clinics and 
crisis intervention teams.  
Participants will be asked to complete the Patient Health Questionnaire (PHQ-9) either in 
hardcopy at each session or electronically though the CHESS smartphone application to 
assess their depressive symptoms and thoughts of self-harm. Participants will also be 
asked to complete the Generalized Anxiety Disorder (GAD-7), to assess the severity of 
their anxiety symptoms, through the CHESS Smartphone Application. At the first and 
sixth session, participants will be asked to complete the Medical Outcomes Survey Short 
Form (SF-12), a measure of general health, and a quality of life questionnaire (EQ-5D). 
At the final session, participants will also be asked to complete a questionnaire about 
their experiences in the study. Specifically, users will be asked to complete a Likert scale 
which evaluates the user comprehension and practicality of the application, and will be 
asked to comment on the e-therapy process (see questionnaire in Appendix one). At the 
end of their participation in the study, they will also be asked to complete a CHESS 

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Smartphone Application User Satisfaction survey which is administered through the 
smartphone application. Participants will also be asked after their final session to 
complete a qualitative interview to examine the process of enrolment into the study, what 
they found useful in the therapy and what aspects of the therapy could be improved. 
Participants in the qualitative interviews will be interviewed by a Research Assistant who 
is independent of the enrolment and therapy process. We will approach all men who took 
part in the therapy to complete these qualitative interviews. We will ask their permission 
to audio record the interviews, and we will transcribe the recordings for analysis. A 
summary of the findings for each participant will be returned to each participant for 
feedback. 
Furthermore, we will invite staff who work in the Emergency Department and Psychiatric 
Emergency Services at the General and Civic Campuses to complete a qualitative 
interview describing barriers and opportunities for referring men to the smart phone 
assisted therapy. We will aim to interview up to six (6) mental health and Emergency 
Department staff, or until data saturation is reached.  
4.0 ANALYSIS 
We will use conventional content analysis to analyse the data [16]. Themes will be 
identified independently by two separate coders. 
5.0 OUTCOMES 
5.1 Refinement of the intervention: 
At the end of the pilot study, we will develop the patient and clinician treatment manuals 
to incorporate the smartphone application and customize them so they are specific to our 
target audience. The customized treatment manual will take into account information 
from user’s experiences of the combined therapy, the questionnaires and qualitative 
interviews.  
5.2 Acceptability of the intervention and data collection: 
We will ask clinicians and patients about the acceptability of the intervention and the 
acceptability of using routine data sources as outcome measures. This will inform 
methods of recruitment for the larger cluster randomized controlled trial. Acceptability 
will be assessed by a survey of study participants (see Appendix one) and by qualitative 
interviews. We are aiming for at least two thirds of the participants to rate all questions 
about comprehension and user practicability as either somewhat agree, agree or strongly 
agree. Similarly we are aiming for two thirds of the participants to rate the question about 
acceptability of data collection as somewhat agree, agree or strongly agree.  
 
 

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5.3 Feasibility of recruitment 
We will describe the proportion of men who consented to be participants after being 
approached by the study staff, as well as the proportion of men who present with 
intentional self-harm who are referred to the study. 
 
References 
1. Canadian Institute for Health Information (2011) Health Indicators 2011. Canadian  
Institute for Health Information,, Ottawa, Ontario 
2. Hawton K, Bergen H, Casey D, Simkin S, Palmer B, Cooper J, Kapur N, Horrocks J,  
House A, Lilley R, Noble R, Owens D (2007) Self-harm in England: a tale of  
three cities. Multicentre study of self-harm. Social Psychiatry & Psychiatric  
Epidemiology 42 (7):513-521 
3. Owens D, Horrocks J, House A (2002) Fatal and non-fatal repetition of self-harm:  
Systematic review. British Journal of Psychiatry 181 (3):193-199.  
doi:10.1192/bjp.181.3.193 
4. Finkelstein Y, MacDonald EM, Hollands S, Sivilotti MLA, Hutsn JR, Mamdani MM,  
Koren G, Juurlink DN (2015) Risk of suicide following deliberate self-poisoning.  
JAMA Psychiatry 72 (6):570-575 
5. Da Cruz D, Pearson A, Saini P, Miles C, While D, Swinson N, Williams A, Shaw J,  
Appleby L, Kapur N (2011) Emergency department contact prior to suicide in  
mental health patients. Emergency Medicine Journal 28 (6):467-471.  
doi:http://dx.doi.org/10.1136/emj.2009.081869 

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6. Hawton K, Harriss L, Zahl D (2006) Deaths from all causes in a long-term follow-up  
study of 11,583 deliberate self-harm patients. Psychological Medicine 36 (3):397- 
405 
7. Caterino JM, Sullivan AF, Betz ME, Espinola JA, Miller I, Camargo CA, Jr.,  
Boudreaux ED, Emergency Department Safety A, Follow-up Evaluation I (2013)  
Evaluating current patterns of assessment for self-harm in emergency  
departments: a multicenter study. Academic Emergency Medicine 20 (8):807-815.  
doi:http://dx.doi.org/10.1111/acem.12188 
8. Hawton K, Arensman E, Townsend E, Bremner S, Feldman E, Goldney R, Gunnell D,  
Hazell P, van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L  
(1998) Deliberate self harm: systematic review of efficacy of psychosocial and  
pharmacological treatments in preventing repetition. BMJ 317 (7156):441-447 
9. Hawton K, McKeown S, Day A, Martin P, O'Connor M, Yule J (1987) Evaluation of  
out-patient counselling compared with general practitioner care following  
overdoses. Psychological Medicine 17 (3):751-761 
10. National Institute for Health and Clinical Excellence (2011) Longer-term care and  
treatment of self-harm. vol CG133.  
11. Carroll R, Metcalfe C, Gunnell D (2014) Hospital management of self-harm patients  
and risk of repetition: Systematic review and meta-analysis. Journal of Affective  
Disorders 168:476-483 

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12. Hatcher S, Sharon C, Parag V, Collins N (2011) Problem solving therapy for people  
who present to hospital with self-harm: Zelen randomised controlled trial. British  
Journal of Psychiatry 199:310-316 
13. Hatcher S, Sharon C, House A, Collins N, Collings S, Pillai A (2015) The ACCESS  
study: A Zelen randomised controlled trial of a treatment package including  
problem solving therapy compared to treatment as usual in people who present to  
hospital after self-harm. British Journal of Psychiatry 206 (3):229-236 
14. Hatcher S, Coupe N, Durie M, Elder H, Tapsell R, Wikiriwhi K, Parag V (2011) Te  
Ira Tangata: A Zelen randomised controlled trial of a treatment package including  
problem solving therapy compared to treatment as usual in Maori who present to  
hospital after self harm. Trials 12 (117). doi:10.1186/1745-6215-12-117 
15. Gustafson D, McTavish FM, Chih M-Y, Atwood AK, Johnson RA, Boyle MG, Levy  
MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D (2014) A  
smartphone application to support recovery from alcoholism: A randomized  
controlled trial. JAMA Psychiatry 71 (5):566-572 
16. Hsiu-Fang H, Shannon SE (2005) Three approaches to qualitative content analysis.  
Qualitative Health Research 15 (9):1277-1288