Pilot Study of a Smart Phone Assisted Problem Solving Therapy for Men Who Have Presented With Intentional Self-harm to Emergency Departments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ottawa
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
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.
Intervention: CHESS Mobile Health smart phone application (Device)
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.
Intervention: Problem solving therapy (Behavioral)
Outcomes
Primary Outcomes
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
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.
Secondary Outcomes
- Physical Functioning(Baseline and Week 5)
- Physical Role Limitations(Baseline, Week 5)
- Vitality(Baseline, Week 5)
- Mental Health Functioning(Baseline, Week 5)
- Bodily Pain(Baseline, Week 5)
- Social Functioning(Baseline, Week 5)
- Emotional Role Limitations(Baseline, Week 5)
- General Health(Baseline, Week 5)
- Perceived Overall Health(Baseline, Week 5)
- Health-Related Quality of Life(Baseline and Week 5)
- Participant Exit Questionnaire(within 4 months of study completion)
Investigators
Dr. Simon Hatcher
Vice Chair of Research, Department of Psychiatry
University of Ottawa
