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Ottawa Suicide Prevention in Men Pilot Study

Pilot Study of a Smart Phone Assisted Problem Solving Therapy for Men Who Have Presented With Intentional Self-harm to Emergency Departments

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02718248
Acronym
OSSUPilot
Enrollment
7
Registered
2016-03-24
Start date
2016-09-30
Completion date
2017-06-30
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

self-harm, problem-solving therapy, emergency department, e-therapy, suicide prevention

Brief summary

To refine a novel intervention using a combination of a smart phone application with best practice psychotherapy for men who have presented to hospital with intentional self-harm. The outcome will be change in baseline of scores on a depression rating scale the PHQ-9 at six weeks. Moreover, the investigators will ask participants 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 and the creation of a treatment manual.

Detailed description

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. 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, the investigators 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. 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. 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. 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. About a quarter of suicides are preceded by a hospital visit due to non-fatal self-harm in the previous year. 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. 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. 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 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 Strategy (CASP) 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 Ontario Health Insurance (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. 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. The investigators have received funding for a multicentre cluster randomized trial from the Ontario Strategy for Patient Oriented Research (SPOR) Support for People and Patient Oriented Research and Trials (SUPPORT) Unit funded by Canadian Institutes for Health Research (CIHR) and the Ontario Ministries of Health and Research and Innovation (MRI) 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 will build on previous work by trying to extend the range and intensity of therapy. The investigators will do this by supplementing it with a sophisticated smart phone application that has already demonstrated its effectiveness in men with substance abuse disorders. The investigators 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, a pilot study will be implemented to refine the intervention and treatment manual, as well as to test the acceptability and feasibility of the intervention to patients. The pilot study has two aims. The first is to refine a novel intervention using a combination of a smart phone application with best practice psychotherapy for men who have presented to hospital with intentional self-harm. The primary outcome will be the change from baseline in scores on a depression rating scale the PHQ-9 at six weeks. The second aim is to test acceptability. The investigators will ask 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. We will also create a treatment manual for problem solving therapy that incorporates the use of a smart phone application.

Interventions

DEVICECHESS Mobile Health smart phone application

A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.

BEHAVIORALProblem solving therapy

Face to face problem solving therapy every week for six weeks.

Sponsors

University of Ottawa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participant is male; * Participant is 18 years of age or older; * Participant has presented via Emergency Department to The Ottawa Hospital General and Civic Campuses with intentional self-harm; * Participant is willing to return to the The Ottawa Hospital General Campus for follow-up appointments; * Participant is willing to consent to participate in the study.

Exclusion criteria

* Participant is unable to read or understand English; * Participant has cognitive impairments that render them incapable of using a smart phone; * Participant does not have a smart phone and/or a smart phone with a data plan; * Participants who in the opinion of the investigator will be unlikely to commit to a three month long study.

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6Baseline, Week 1, Week 2, Week 3, Week 4, Week 5Measures change in the severity of depressive symptoms. Total scores on this scale range from 0 to 27, with higher scores indicating more severe depression symptoms. The scores on the Patient Health Questionnaire (PHQ-9) scale should be interpreted as follows: 0-4: Minimal Depression; 5-9: Mild Depression 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20 and Above: Severe Depression.

Secondary

MeasureTime frameDescription
Physical FunctioningBaseline and Week 5Physical Functioning was measured using the Physical Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Functioning Subscale is scored using a range of 0-100, with a higher score indicating better physical functioning.
Physical Role LimitationsBaseline, Week 5Physical Role Limitations was measured using the Physical Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to physical health difficulties.
Emotional Role LimitationsBaseline, Week 5Emotional Role Limitations was measured using the Emotional Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Emotional Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to emotional health difficulties.
VitalityBaseline, Week 5Vitality was measured using the Vitality subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Vitality subscale is scored using a range of 0-100, with a higher score indicating a higher degree of vitality.
General HealthBaseline, Week 5General Health was measured using the General Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The General Health Subscale is scored using a range of 0-100, with a higher score indicating higher levels of general health.
Mental Health FunctioningBaseline, Week 5Mental Health Functioning was measured using the Mental Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Mental Health Functioning Subscale is scored using a range of 0-100, with a higher score indicating better mental health functioning.
Bodily PainBaseline, Week 5Bodily Pain was measured using the Bodily Pain subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Bodily Pain Subscale is scored using a range of 0-100, with a higher score indicating lower levels of bodily pain.
Social FunctioningBaseline, Week 5Social Functioning was measured using the Social Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Social Functioning Subscale is scored using a range of 0-100, with a higher score indicating higher social functioning.
Health-Related Quality of LifeBaseline and Week 5Generic health-related quality of life index. The total scores on this measure range from 11111 to 33333, with lower values indicating higher levels of health-related quality of life.
Perceived Overall HealthBaseline, Week 5Participants were asked to use the EuroQol 5 Dimensions Visual Analytic Scale to assess their overall health on a scale from 0 to 100, with 100 being the best possible health state.
Participant Exit Questionnairewithin 4 months of study completionThe investigators will ask participants about the user comprehension, user practicality and the methods of data collection with regards to the CHESS Mobile Health smart phone application. The Participant Exit Questionnaire will also ask that users make comments or suggestions for future use and development of the application. This will test the acceptability of the intervention and the acceptability of using routine data sources as outcome measures.

Other

MeasureTime frameDescription
Recruitment Rates at 6 MonthsWithin 6 months of study launchWill be used to assess the feasibility of recruitment for a larger, multicentre cluster randomized controlled trial (RCT). To test feasibility in patients the investigators 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, the aim is that at least half of men who present with intentional self-harm to the psychiatric emergency service will be approached and complete the The Ottawa Hospital (TOH) form allowing contact details to be passed on to researchers.

Countries

Canada

Participant flow

Recruitment details

Participant recruitment took place over a 6 month period from Sept. 2016 to Feb. 2017. TOH ED staff were asked to approach participants with information about the study and refer any eligible men to the Research Coordinator. Once participants were referred to the Research Coordinator, she contacted them by telephone and scheduled a Baseline Visit.

Pre-assignment details

No participants were excluded from this study post-enrollment.

Participants by arm

ArmCount
CHESS Mobile Health Group
The intervention will be six weekly one hour sessions of face-to-face problem solving therapy combined with the CHESS Mobile Health smart phone application (Comprehensive Health Enhancement Support System - CHESS). The CHESS Mobile Health smart phone application enables users to access relevant resources, create a support network and check in regularly with carers. The intervention will be delivered by Dr. Hatcher, a staff psychiatrist in Liaison Psychiatry at The Ottawa Hospital General Campus. CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy. Problem solving therapy: Face to face problem solving therapy every week for six weeks.
7
Total7

Baseline characteristics

CharacteristicCHESS Mobile Health Group
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
Age, Continuous27.43 years
STANDARD_DEVIATION 8.142
Bodily Pain71.43 units on a scale
STANDARD_DEVIATION 30.375
Emotional Role Limitations26.79 units on a scale
STANDARD_DEVIATION 26.446
EuroQol 5 Dimensions Visual Analytic Scale47.57 units on a scale
STANDARD_DEVIATION 11.53
General Health42.14 units on a scale
STANDARD_DEVIATION 29.277
General Health Related Quality of Life11223 units on a scale
Mental Health Functioning17.86 units on a scale
STANDARD_DEVIATION 17.466
Physical Functioning82.14 units on a scale
STANDARD_DEVIATION 18.898
Physical Role Limitations75 units on a scale
STANDARD_DEVIATION 23.936
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Canada
7 participants
Severity of Depression Symptoms18.29 units on a scale
STANDARD_DEVIATION 5.529
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
7 Participants
Social Functioning28.57 units on a scale
STANDARD_DEVIATION 22.493
Vitality25.0 units on a scale
STANDARD_DEVIATION 20.412

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 7
other
Total, other adverse events
5 / 7
serious
Total, serious adverse events
0 / 7

Outcome results

Primary

Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6

Measures change in the severity of depressive symptoms. Total scores on this scale range from 0 to 27, with higher scores indicating more severe depression symptoms. The scores on the Patient Health Questionnaire (PHQ-9) scale should be interpreted as follows: 0-4: Minimal Depression; 5-9: Mild Depression 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20 and Above: Severe Depression.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

Population: Throughout the course of the study, the following study time points were missed: Week 1 (2 participants), Week 3 (1 participant) and Week 4 (1 participant).

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupChange From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6Week 119.8 units on a scaleStandard Deviation 5.07
CHESS Mobile Health GroupChange From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6Week 215.17 units on a scaleStandard Deviation 5.565
CHESS Mobile Health GroupChange From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6Week 316.86 units on a scaleStandard Deviation 6.619
CHESS Mobile Health GroupChange From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6Week 416.83 units on a scaleStandard Deviation 6.853
CHESS Mobile Health GroupChange From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6Week 513.71 units on a scaleStandard Deviation 9.995
Secondary

Bodily Pain

Bodily Pain was measured using the Bodily Pain subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Bodily Pain Subscale is scored using a range of 0-100, with a higher score indicating lower levels of bodily pain.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupBodily PainBaseline71.43 units on a scaleStandard Deviation 30.375
CHESS Mobile Health GroupBodily PainWeek 582.14 units on a scaleStandard Deviation 18.898
Secondary

Emotional Role Limitations

Emotional Role Limitations was measured using the Emotional Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Emotional Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to emotional health difficulties.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupEmotional Role LimitationsBaseline26.79 units on a scaleStandard Deviation 26.446
CHESS Mobile Health GroupEmotional Role LimitationsWeek 544.64 units on a scaleStandard Deviation 25.877
Secondary

General Health

General Health was measured using the General Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The General Health Subscale is scored using a range of 0-100, with a higher score indicating higher levels of general health.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupGeneral HealthBaseline42.14 units on a scaleStandard Deviation 29.277
CHESS Mobile Health GroupGeneral HealthWeek 548.57 units on a scaleStandard Deviation 23.755
Secondary

Health-Related Quality of Life

Generic health-related quality of life index. The total scores on this measure range from 11111 to 33333, with lower values indicating higher levels of health-related quality of life.

Time frame: Baseline and Week 5

ArmMeasureGroupValue (MEDIAN)
CHESS Mobile Health GroupHealth-Related Quality of LifeBaseline11223 units on a scale
CHESS Mobile Health GroupHealth-Related Quality of LifeWeek 511313 units on a scale
Secondary

Mental Health Functioning

Mental Health Functioning was measured using the Mental Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Mental Health Functioning Subscale is scored using a range of 0-100, with a higher score indicating better mental health functioning.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupMental Health FunctioningBaseline17.86 units on a scaleStandard Deviation 17.466
CHESS Mobile Health GroupMental Health FunctioningWeek 530.36 units on a scaleStandard Deviation 21.478
Secondary

Participant Exit Questionnaire

The investigators will ask participants about the user comprehension, user practicality and the methods of data collection with regards to the CHESS Mobile Health smart phone application. The Participant Exit Questionnaire will also ask that users make comments or suggestions for future use and development of the application. This will test the acceptability of the intervention and the acceptability of using routine data sources as outcome measures.

Time frame: within 4 months of study completion

ArmMeasureGroupValue (NUMBER)
CHESS Mobile Health GroupParticipant Exit QuestionnaireApplication Easy to Install100.0 percentage of participants who agreed
CHESS Mobile Health GroupParticipant Exit QuestionnaireApplication is User Friendly85.7 percentage of participants who agreed
CHESS Mobile Health GroupParticipant Exit QuestionnaireApplication was easy to use71.4 percentage of participants who agreed
CHESS Mobile Health GroupParticipant Exit QuestionnairePST is a good fit for me71.4 percentage of participants who agreed
CHESS Mobile Health GroupParticipant Exit QuestionnaireIn PST we worked on what I wanted85.7 percentage of participants who agreed
CHESS Mobile Health GroupParticipant Exit QuestionnaireApplication was useful28.6 percentage of participants who agreed
CHESS Mobile Health GroupParticipant Exit QuestionnaireI would use the application again42.9 percentage of participants who agreed
Secondary

Perceived Overall Health

Participants were asked to use the EuroQol 5 Dimensions Visual Analytic Scale to assess their overall health on a scale from 0 to 100, with 100 being the best possible health state.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupPerceived Overall HealthBaseline47.57 units on a scaleStandard Deviation 11.53
CHESS Mobile Health GroupPerceived Overall HealthWeek 560.29 units on a scaleStandard Deviation 14.795
Secondary

Physical Functioning

Physical Functioning was measured using the Physical Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Functioning Subscale is scored using a range of 0-100, with a higher score indicating better physical functioning.

Time frame: Baseline and Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupPhysical FunctioningBaseline82.14 units on a scaleStandard Deviation 18.898
CHESS Mobile Health GroupPhysical FunctioningWeek 592.86 units on a scaleStandard Deviation 18.898
Secondary

Physical Role Limitations

Physical Role Limitations was measured using the Physical Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to physical health difficulties.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupPhysical Role LimitationsBaseline75.0 units on a scaleStandard Deviation 23.936
CHESS Mobile Health GroupPhysical Role LimitationsWeek 583.93 units on a scaleStandard Deviation 18.7
Secondary

Social Functioning

Social Functioning was measured using the Social Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Social Functioning Subscale is scored using a range of 0-100, with a higher score indicating higher social functioning.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupSocial FunctioningBaseline28.57 units on a scaleStandard Deviation 22.493
CHESS Mobile Health GroupSocial FunctioningWeek 535.71 units on a scaleStandard Deviation 19.67
Secondary

Vitality

Vitality was measured using the Vitality subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Vitality subscale is scored using a range of 0-100, with a higher score indicating a higher degree of vitality.

Time frame: Baseline, Week 5

ArmMeasureGroupValue (MEAN)Dispersion
CHESS Mobile Health GroupVitalityBaseline25.00 units on a scaleStandard Deviation 20.412
CHESS Mobile Health GroupVitalityWeek 546.43 units on a scaleStandard Deviation 33.63
Other Pre-specified

Recruitment Rates at 6 Months

Will be used to assess the feasibility of recruitment for a larger, multicentre cluster randomized controlled trial (RCT). To test feasibility in patients the investigators 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, the aim is that at least half of men who present with intentional self-harm to the psychiatric emergency service will be approached and complete the The Ottawa Hospital (TOH) form allowing contact details to be passed on to researchers.

Time frame: Within 6 months of study launch

Population: This group includes all participants referred to the study (N=15).

ArmMeasureValue (NUMBER)
CHESS Mobile Health GroupRecruitment Rates at 6 Months46.6 percentage of participants enrolled

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026