Clinical trial NCT03473535: BEACON Suicide Prevention in Men Study
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intentional Self-Harm
Suicide
Keywords: self-harm
problem-solving therapy
emergency department
e-therapy
suicide prevention
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
First posted: 2018-03-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the use of problem-solving therapy (PST), supplemented by a smartphone application, in the treatment of men who present to the Emergency Departments in Ontario. A total of 100 men in 5 Emergency Departments will be enrolled and randomized to receive either face-to-face PST or face-to-face PST supplemented by the BEACON Suicide Prevention smartphone application. Face-to-face therapy may be provided via videoconference to accommodate patient preference and ongoing pandemic restrictions. Participants will complete six sessions of PST and outcomes will be measured at baseline, 6 weeks, two post-therapy follow-up time points (3 and 6 months). Participants will also be asked to complete a qualitative interview about their participation in the study and their experience with the smartphone application.

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, we use the term 'self-harm' to describe 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 (ED) with self-harm is difficult to accurately assess and often underreported. Data from CIHI results in an estimated 8,250 ED visits annually (as of 2014) in Ontario. However, using data from Ottawa, Ontario EDs the rate of presentation appears to be more than double at 1,600 presentations annually. Therefore, it is possible that the provincial rate may exceed 16,000 unique presentations. 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 also has a strong association with suicide: 7 patients per 1000 (approximately 1.6%) die by suicide in the year after attending emergency departments with a non-fatal episode, with the incidence rate nearly double in men compared to women, representing a risk nearly 50 times greater than the general population. All-cause mortality is also higher for individuals who self-harm, with significantly more deaths from natural causes and accidents than in the general population. As such, self-harm is associated with a 40-year reduction in average life expectancy. Whilst only four of ten people who present with self-harm are men, they account for nearly two-thirds of suicides after an episode and are far more likely than women to die a premature death from other causes. 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.

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. Recurrent self-harm is associated with significant 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 the 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, and there is no standard protocol for therapy. 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. 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, when offered, typically include intensive and lengthy treatments such as dialectical behaviour therapy or mindfulness-based therapy. The evidence for the effectiveness of these specialist therapies comes almost entirely from studies in women. Problem-solving therapy (PST) has been identified as a promising intervention in the treatment of self-harm. PST seeks to improve an individual's ability to cope better with both minor (e.g., chronic daily problems) and major (e.g., traumatic events) life stresses to increase mental and physical health. The major goals of PST are to help individuals adopt a positive worldview and way of approaching their problems and increase problem-solving skills in order to better cope with life stressors.

The investigators have received funding for a multi-site individual randomized control trial (RCT) 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) studying the feasibility and effectiveness of PST with the use of the BEACON smartphone application compared to PST alone in men who present to Emergency Departments with intentional self-harm. The rationale for focusing on men is that they are less likely to seek care but represent nearly two-thirds of those who die by suicide after an index episode of self-harm, 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 PST with a sophisticated smartphone application (BEACON) that has already demonstrated its effectiveness in men with substance abuse disorders. For the purpose of this study, the smartphone application has been re-designed for the treatment of self-harm.

Participants that consent to take part in this study will be assigned randomly to one of two groups: a "control" group and a study intervention group. Both groups receive six free one-on-one sessions of PST over a period of eight weeks. If placed in the control group, the participant will only receive problem-solving therapy and treatment as usual. The intervention group will receive problem-solving therapy, delivered in the same manner, but will be provided access to a smartphone application (BEACON) designed to support the therapy. Eligible participants will consist of men 18 years of age or older who have presented via the Emergency Department of a recruiting site for self-harm and agree to participate in the study. Participants will be asked to complete a series of outcome measures assessing suicidal thoughts and behaviour, problem-solving, mental health and substance use, quality of life and health care service use. These outcomes will be completed at baseline, 6 weeks, 3 months and 6 months. Participants will also be asked to participate in a qualitative interview at the end of the study to gather information on their experience of being in the study, barriers or facilitators to participation and the use of the smartphone application. PST sessions will be delivered by a trained Research Therapist. PST Sessions and other study visits may take place over videoconference, using an approved platform.

Categorical participant characteristics, such as gender identity, marital status and education level will be reported using frequencies and percentages. Continuous characteristics, such as age, will be reported using mean ±SD for any continuous variables that are normally distributed, and as a median score. For non-normally distributed variables the 25th and 75th percentiles will be used. Non-normally distributed variables will also be dichotomized and analyzed as categorical data. Changes in participants' scores from their baseline visit to follow-up at six months will be analyzed by use of repeated measures ANOVA with a 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.

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. 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.

The primary outcome measure is the Beck Scale for Suicide Ideation (BSS), a 24-item self-report questionnaire for detecting and measuring the current intensity of a subject's thoughts, feelings and suicidal behaviours. Secondary outcome measures include: the 9-Item Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Questionnaire (GAD-7), the Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5) screening tool, the EuroQol 5 Dimensions (EQ-5D-5L) questionnaire, the Experienced Meaning in Life (EMIL) scale, the Multidimensional Scale of Perceived Social Support (MSPSS), the Alcohol Use Disorder Identification Test (AUDIT), the Drug Abuse Screening Test (DAST-10), and two sub-scales from the Conformity to Masculine Norms Scale (CMNI). In order to assess the impact of the intervention on a participant's social problem-solving skills, the Social Problem Solving Inventory-Revised Short Form (SPSI-R:S) will be used, and health service use will be captured using the Questionnaire on Healthcare Consumption and Productivity losses for patients with a Psychiatric Disorder (TiC-P). We will also use routinely collected administrative data obtained from the Institute for Clinical Evaluative Sciences (ICES). The ICES data collected will characterize a participant's previous hospitalizations for self-harm, previous presentations to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to the hospital for any reason, outpatient appointments for any reason, and primary care visits.

Eligibility criteria: Inclusion Criteria:

* Identifies as Male.
* 18 years of age or older.
* Has presented via the Emergency Department with self-harm in the preceding 4 weeks
* Able to read and understand English, French or read or understand Oji Cree.
* Willing to attend six problem-solving therapy sessions for a period of up to eight weeks.
* Willing to use a smartphone application to facilitate the treatment of self-harm.
* Willing to return to the hospital for follow-up appointments.
* Willing and able to provide informed consent.
* Willing to use e-mail for study activities.

Exclusion Criteria:

* Identifies as female.
* Has presented to the Emergency Department for a reason other than self-harm.
* In the opinion of the investigator is unlikely to commit to a six-month long study.

Primary outcomes:
measure: Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
Secondary outcomes:
measure: Change in Severity of Depression Symptoms - 9-Item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Severity of Anxiety Symptoms - 7-Item General Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Post-Traumatic Stress Disorder Symptoms - 5-Item Primary Care Post-Traumatic Stress Disorder Screening Tool for DSM-5 (PC-PTSD-5)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment
measure: Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Meaning in Life - 40-Item Experienced Meaning in Life Questionnaire (EMIL): Four sub-scales (Creative, Experiential, Attitudinal, Ultimate)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Perceived Social Supports - 12-Item Multidimensional Scale of Perceived Social Supports (MSPSS)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Alcohol Misuse - 3-Item Alcohol Use Disorder Identification Test (AUDIT-C)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Alcohol Misuse - 10-Item Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Change in Drug Misuse - 10-Item Drug-Abuse Screening Test (DAST-10)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Emotional Control Sub-Scale
timeFrame: Baseline Visit
measure: Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Self-Reliance Sub-Scale
timeFrame: Baseline Visit
measure: Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Previous Hospitalizations for Self-Harm
timeFrame: 6 months Post-Enrollment.
measure: Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentation to Hospital for Self-Harm
timeFrame: 6 months Post-Enrollment.
measure: Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentations to the Hospital for Any Reason Other Than Self-Harm
timeFrame: 6 months Post-Enrollment.
measure: Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Admission to the Hospital for Any Reason.
timeFrame: 6 months Post-Enrollment.
measure: Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Outpatient Appointment for Any Reason.
timeFrame: 6 months Post-Enrollment.
measure: Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Primary Care Visits.
timeFrame: 6 months Post-Enrollment.
measure: Problem-Solving Skills - 25-Item Social Problem Solving Inventory - Revised Short Form (SPSI-R:S)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
measure: Health Service Use - Questionnaire on Healthcare Consumption and Productivity losses for patients with a Psychiatric Disorder (TiC-P)
timeFrame: Baseline; Session 6; 3 months; 6 months Post-Enrollment.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Simon Hatcher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Marnin Heisel, PhD
role: PRINCIPAL_INVESTIGATOR
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