Clinical trial NCT02718248: Ottawa Suicide Prevention in Men Pilot Study
Official title: Pilot Study of a Smart Phone Assisted Problem Solving Therapy for Men Who Have Presented With Intentional Self-harm to Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: self-harm
problem-solving therapy
emergency department
e-therapy
suicide prevention
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Secondary outcomes:
measure: Physical Functioning
timeFrame: Baseline and Week 5
measure: Physical Role Limitations
timeFrame: Baseline, Week 5
measure: Emotional Role Limitations
timeFrame: Baseline, Week 5
measure: Vitality
timeFrame: Baseline, Week 5
measure: General Health
timeFrame: Baseline, Week 5
measure: Mental Health Functioning
timeFrame: Baseline, Week 5
measure: Bodily Pain
timeFrame: Baseline, Week 5
measure: Social Functioning
timeFrame: Baseline, Week 5
measure: Health-Related Quality of Life
timeFrame: Baseline and Week 5
measure: Perceived Overall Health
timeFrame: Baseline, Week 5
measure: Participant Exit Questionnaire
timeFrame: within 4 months of study completion
Other outcomes:
measure: Recruitment Rates at 6 Months
timeFrame: Within 6 months of study launch
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Simon Hatcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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