The BEACON Study: Smartphone-Assisted Problem-Solving Therapy in Men Presenting to the ED With Self-Harm (Protocol A)
NCT ID: NCT03489382
Last Updated: 2021-10-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2020-03-31
Study Completion Date
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST) service across Emergency Departments in Ontario. A total of 25 Emergency Departments have been randomized to either usual care or the smartphone-assisted PST service intervention. The main cluster randomized controlled trial will use data collected from the Institute of Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and re-presentations to hospital for self-harm as well as other health service use one-year post study launch.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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), the Ontario Ministry of Health and Long-Terms Care (MOHLTC), and the Ontario Ministry of Research, Innovation and Science (MRIS), 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.
Given the complexity of the proposed study, the investigators have separated the overarching research proposal into two parts, designated "Protocol A" and "Protocol B." Protocol A refers to a comprehensive secondary analysis the investigators will be carrying out using data from the Institute for Clinical Evaluative Sciences (ICES), and Protocol B refers to the active components of the intervention, those carried out with human subjects receiving six sessions of blended, problem solving therapy as opposed to routine care. The following description outlines the research protocol developed under the heading "Protocol A."
Data collected from the ICES will be used to assess the impact of our intervention on suicides and re-presentations to hospital for self-harm, as well as providing an estimation of the intervention's economic impact on the Ontario healthcare system. This data is routinely collected and housed by ICES, and access to all outcome data has been agreed upon in advance of the study launch. Given that this component of the study focuses on the evaluation of the intervention based on routinely collected population-level data, there will be no individual participant recruitment; instead, the unit of analysis will be the individual patient, with eligibility determined by the patient's presentation at either an intervention or control site's Emergency Department for self-harm. To minimize the risk of imbalances between the study arms, allocation of a site to an intervention or control arm was completed using covariate constrained allocation, based on geographic and catchment area, the availability of onsite psychiatric services assessing Emergency Department visitors, rates of representation for self-harm, and facility size, defined by the average number of presentations for self-harm over a three year period. Dichotomous primary and secondary outcome measures will be compared according to study arm, using frequencies and percentages.
The main study outcome measure for Protocol A consists of a composite measure, combining the incidence of suicide and/or representations to any Emergency Department in Ontario for self-harm in the year following the index episode of self-harm. Secondary objectives include: representation to any Emergency Department in Ontario for any reason, admission to any hospital in Ontario for any reason, hospital appointments in Ontario for any reason, primary care appointments in Ontario for any reason, mortality for reasons other than suicide, total healthcare costs, physician healthcare costs, Emergency Department health care costs, hospitalization healthcare costs, and other healthcare costs. All economic analyses will be similarly carried out with the province of Ontario considered as the population of interest. The primary composite outcome measure will be compared between the intervention and control sites using generalized linear mixed effect regression, accounting for the pre-and post-intervention measures using repeated cross-sectional analysis. Differences between the arms will be expressed as absolute and relative differences in proportions together with 95% confidence intervals. Models will account for clustering at the level of the Emergency Department and over time using random effects. Additional analyses will adjust for individual prognostic variable including age, ethnicity, pre-specified comorbidities, and repeat as compared to first-time presentations for self-harm.
The investigators will conduct a cost-utility analysis from a health system's perspective using a decision analytic model. Costs associated with the intervention will be summarized over a one-year period using a micro-costing technique. This will involve identifying, costing and valuing all resources used. An incremental cost per one additional quality-adjusted life year (QALY) gained will be estimated using one-way and probabilistic sensitivity analyses. This cost-utility analysis will adhere to the best practices for conducting and reporting of health economic evaluations.
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), the Ontario Ministry of Health and Long-Terms Care (MOHLTC), and the Ontario Ministry of Research, Innovation and Science (MRIS), 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.
Given the complexity of the proposed study, the investigators have separated the overarching research proposal into two parts, designated "Protocol A" and "Protocol B." Protocol A refers to a comprehensive secondary analysis the investigators will be carrying out using data from the Institute for Clinical Evaluative Sciences (ICES), and Protocol B refers to the active components of the intervention, those carried out with human subjects receiving six sessions of blended, problem solving therapy as opposed to routine care. The following description outlines the research protocol developed under the heading "Protocol A."
Data collected from the ICES will be used to assess the impact of our intervention on suicides and re-presentations to hospital for self-harm, as well as providing an estimation of the intervention's economic impact on the Ontario healthcare system. This data is routinely collected and housed by ICES, and access to all outcome data has been agreed upon in advance of the study launch. Given that this component of the study focuses on the evaluation of the intervention based on routinely collected population-level data, there will be no individual participant recruitment; instead, the unit of analysis will be the individual patient, with eligibility determined by the patient's presentation at either an intervention or control site's Emergency Department for self-harm. To minimize the risk of imbalances between the study arms, allocation of a site to an intervention or control arm was completed using covariate constrained allocation, based on geographic and catchment area, the availability of onsite psychiatric services assessing Emergency Department visitors, rates of representation for self-harm, and facility size, defined by the average number of presentations for self-harm over a three year period. Dichotomous primary and secondary outcome measures will be compared according to study arm, using frequencies and percentages.
The main study outcome measure for Protocol A consists of a composite measure, combining the incidence of suicide and/or representations to any Emergency Department in Ontario for self-harm in the year following the index episode of self-harm. Secondary objectives include: representation to any Emergency Department in Ontario for any reason, admission to any hospital in Ontario for any reason, hospital appointments in Ontario for any reason, primary care appointments in Ontario for any reason, mortality for reasons other than suicide, total healthcare costs, physician healthcare costs, Emergency Department health care costs, hospitalization healthcare costs, and other healthcare costs. All economic analyses will be similarly carried out with the province of Ontario considered as the population of interest. The primary composite outcome measure will be compared between the intervention and control sites using generalized linear mixed effect regression, accounting for the pre-and post-intervention measures using repeated cross-sectional analysis. Differences between the arms will be expressed as absolute and relative differences in proportions together with 95% confidence intervals. Models will account for clustering at the level of the Emergency Department and over time using random effects. Additional analyses will adjust for individual prognostic variable including age, ethnicity, pre-specified comorbidities, and repeat as compared to first-time presentations for self-harm.
The investigators will conduct a cost-utility analysis from a health system's perspective using a decision analytic model. Costs associated with the intervention will be summarized over a one-year period using a micro-costing technique. This will involve identifying, costing and valuing all resources used. An incremental cost per one additional quality-adjusted life year (QALY) gained will be estimated using one-way and probabilistic sensitivity analyses. This cost-utility analysis will adhere to the best practices for conducting and reporting of health economic evaluations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Intentional Self-Harm
Suicide
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
self-harm
problem-solving therapy
emergency department
e-therapy
suicide prevention
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Multi-Centre Cluster Randomized Controlled Trial
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
All data linkage and analyses will be conducted by statisticians who are blind to the study site allocations.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Emergency Departments providing usual care, which includes assessment in hospital followed by placement on a wait list for psychiatric services and access to regional community resources for suicide prevention.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Smartphone Assisted PST
Emergency Departments providing the option to refer men who self-harm to a service that will deliver smartphone-assisted problem solving therapy.
Group Type
EXPERIMENTAL
Smartphone Assisted PST
Intervention Type
OTHER
Emergency Departments randomized to the study intervention will receive:
1. Staff education incorporated into regular teaching rounds at least twice a year about the management of self-harm in the Emergency Department. This will include the dissemination of guidelines on how to ask questions about suicide, assessment of suicide risk, the creation of a management plan and how to refer patients to local mental health resources, including the study.
2. Written materials developed by service users for men who self-harm that outline local resources, distress centre helplines, and follow-up arrangements.
3. The option to refer men who self-harm to a service that will deliver smartphone-assisted PST specifically designed for men.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Smartphone Assisted PST
Emergency Departments randomized to the study intervention will receive:
1. Staff education incorporated into regular teaching rounds at least twice a year about the management of self-harm in the Emergency Department. This will include the dissemination of guidelines on how to ask questions about suicide, assessment of suicide risk, the creation of a management plan and how to refer patients to local mental health resources, including the study.
2. Written materials developed by service users for men who self-harm that outline local resources, distress centre helplines, and follow-up arrangements.
3. The option to refer men who self-harm to a service that will deliver smartphone-assisted PST specifically designed for men.
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has presented with an index episode of intentional self-harm at an eligible Emergency Department in Ontario, Canada.
* Patient is biologically male.
* Patient is 18 years of age or older.
* Patient has a valid OHIP number.
* Patient is biologically male.
* Patient is 18 years of age or older.
* Patient has a valid OHIP number.
Exclusion Criteria
* Patient has presented to the Emergency Department for a reason other than intentional self-harm at an eligible Emergency Department in Ontario, Canada.
* Patient is biologically female.
* Patient is under 18 years of age.
* Patient does not have a valid OHIP number.
* Patient is biologically female.
* Patient is under 18 years of age.
* Patient does not have a valid OHIP number.
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ottawa Hospital Research Institute
OTHER
Sponsor Role
collaborator
University of Ottawa
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Simon Hatcher
Scientist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Simon Hatcher, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Marnin Heisel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Western Ontario, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Klonsky ED. Non-suicidal self-injury in United States adults: prevalence, sociodemographics, topography and functions. Psychol Med. 2011 Sep;41(9):1981-6. doi: 10.1017/S0033291710002497. Epub 2011 Jan 5.
Reference Type
BACKGROUND
Self-Injury Hospitalizations Details for Ontario [Internet]. Ottawa (ON): The Canadian Institute for Health Information. c2018 - [cited 2017 Feb 20] Available from: https://yourhealthsystem.cihi.ca/hsp/indepth?lang=en#/indicator/042/2/C5001/
Reference Type
BACKGROUND
Bethell J, Rhodes AE. Identifying deliberate self-harm in emergency department data. Health Rep. 2009 Jun;20(2):35-42.
Reference Type
BACKGROUND
Gunnell D, Bennewith O, Peters TJ, House A, Hawton K. The epidemiology and management of self-harm amongst adults in England. J Public Health (Oxf). 2005 Mar;27(1):67-73. doi: 10.1093/pubmed/fdh192. Epub 2004 Nov 25.
Reference Type
BACKGROUND
Hawton K, Bergen H, Casey D, Simkin S, Palmer B, Cooper J, Kapur N, Horrocks J, House A, Lilley R, Noble R, Owens D. Self-harm in England: a tale of three cities. Multicentre study of self-harm. Soc Psychiatry Psychiatr Epidemiol. 2007 Jul;42(7):513-21. doi: 10.1007/s00127-007-0199-7. Epub 2007 May 21.
Reference Type
BACKGROUND
Health Indicators 2013 [Internet]. Ottawa (ON): The Canadian Institute for Health Information. c2013 - [cited 2017 Feb 20] Available from: https://secure.cihi.ca/free_products/HI2013_EN.pdf
Reference Type
BACKGROUND
Heisel MJ, Duberstein PR. Working sensitively and effectively to reduce suicide risk among older adults. In: Kleespies PM, editor. The Oxford handbook of behavioural emergencies and crises. Oxford: Oxford University Press; 2016. P. 335-359.
Reference Type
BACKGROUND
Carroll R, Metcalfe C, Gunnell D. Hospital presenting self-harm and risk of fatal and non-fatal repetition: systematic review and meta-analysis. PLoS One. 2014 Feb 28;9(2):e89944. doi: 10.1371/journal.pone.0089944. eCollection 2014.
Reference Type
BACKGROUND
Finkelstein Y, Macdonald EM, Hollands S, Sivilotti ML, Hutson JR, Mamdani MM, Koren G, Juurlink DN; Canadian Drug Safety and Effectiveness Research Network (CDSERN). Risk of Suicide Following Deliberate Self-poisoning. JAMA Psychiatry. 2015 Jun;72(6):570-5. doi: 10.1001/jamapsychiatry.2014.3188.
Reference Type
BACKGROUND
Owens D, House A. General hospital services for deliberate self-harm. Haphazard clinical provision, little research, no central strategy. J R Coll Physicians Lond. 1994 Jul-Aug;28(4):370-1. No abstract available.
Reference Type
BACKGROUND
Da Cruz D, Pearson A, Saini P, Miles C, While D, Swinson N, Williams A, Shaw J, Appleby L, Kapur N. Emergency department contact prior to suicide in mental health patients. Emerg Med J. 2011 Jun;28(6):467-71. doi: 10.1136/emj.2009.081869. Epub 2010 Jul 26.
Reference Type
BACKGROUND
Bergmans Y, Bolton MJ, Hill A, editors. The CASP blueprint for a Canadian national suicide prevention strategy [Internet]. Winnipeg, MB: Canadian Association for Suicide Prevention; 2009 [cited 2017 Feb 20]. Available: https://suicideprevention.ca/wp-content/uploads/2016/09/SuicidePreventionBlueprint0909.pdf
Reference Type
BACKGROUND
Hawton K, Harriss L, Zahl D. Deaths from all causes in a long-term follow-up study of 11,583 deliberate self-harm patients. Psychol Med. 2006 Mar;36(3):397-405. doi: 10.1017/S0033291705006914. Epub 2006 Jan 10.
Reference Type
BACKGROUND
Comtois KA, Russo J, Snowden M, Srebnik D, Ries R, Roy-Byrne P. Factors associated with high use of public mental health services by persons with borderline personality disorder. Psychiatr Serv. 2003 Aug;54(8):1149-54. doi: 10.1176/appi.ps.54.8.1149.
Reference Type
BACKGROUND
Owens D, Horrocks J, House A. Fatal and non-fatal repetition of self-harm. Systematic review. Br J Psychiatry. 2002 Sep;181:193-9. doi: 10.1192/bjp.181.3.193.
Reference Type
BACKGROUND
Milnes D, Owens D, Blenkiron P. Problems reported by self-harm patients: perception, hopelessness, and suicidal intent. J Psychosom Res. 2002 Sep;53(3):819-22. doi: 10.1016/s0022-3999(02)00327-6.
Reference Type
BACKGROUND
Statistics Canada. Canadian coroner and medical examiner database: Annual report (82-214-X) [Internet]. Ottawa: Public Health Agency of Canada; c2012 [cited 2017 May 12] Available from: www.statcan.gc.ca/pub/82-214-x/82-214-x2012001-eng.pdf
Reference Type
BACKGROUND
Ness J, Hawton K, Bergen H, Cooper J, Steeg S, Kapur N, Clarke M, Waters K. Alcohol use and misuse, self-harm and subsequent mortality: an epidemiological and longitudinal study from the multicentre study of self-harm in England. Emerg Med J. 2015 Oct;32(10):793-9. doi: 10.1136/emermed-2013-202753. Epub 2015 Jan 6.
Reference Type
BACKGROUND
Public Health Agency for Northern Ireland. Northern Ireland registry of self-harm western area: Six year summary report 2007-2012 [Internet]. Belfast: Public Health Agency; c2015 [cited February 20 2017] Available from: http://www.publichealth.hscni.net/sites/default/files/Western%20Trust%206-Year%20Report_0.pdf
Reference Type
BACKGROUND
Health Canada. Acting on what we know: Preventing youth suicide in First Nations. [Internet]. Ottawa: Government of Canada; c2010 [cited 2017 December 01] Available from: http://www.hc-sc.gc.ca/fniah-spnia/pubs/promotion/_suicide/prev_youth-jeunes/index-eng.php#tphp
Reference Type
BACKGROUND
Hawton K, Witt KG, Taylor Salisbury TL, Arensman E, Gunnell D, Hazell P, Townsend E, van Heeringen K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2016 May 12;2016(5):CD012189. doi: 10.1002/14651858.CD012189.
Reference Type
BACKGROUND
Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.
Reference Type
BACKGROUND
Haw C, Hawton K, Casey D, Bale E, Shepherd A. Alcohol dependence, excessive drinking and deliberate self-harm: trends and patterns in Oxford, 1989-2002. Soc Psychiatry Psychiatr Epidemiol. 2005 Dec;40(12):964-71. doi: 10.1007/s00127-005-0981-3. Epub 2005 Dec 9.
Reference Type
BACKGROUND
O'Connor E, Gaynes B, Burda BU, Williams C, Whitlock EP. Screening for Suicide Risk in Primary Care: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-05188-EF-1. Available from http://www.ncbi.nlm.nih.gov/books/NBK137737/
Reference Type
BACKGROUND
ICD-10-CM: International classification of diseases, 10th revision, clinical modification [Internet]. Atlanta (GA): Center for Disease Control National Center for Health Statistics. C2016 - [cited 2017 May 11] Available from: https:www.cdc.gov/nchs/icd/icd10cm.htm
Reference Type
BACKGROUND
Krieger T, Meyer B, Sude K, Urech A, Maercker A, Berger T. Evaluating an e-mental health program ("deprexis") as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial. BMC Psychiatry. 2014 Oct 8;14:285. doi: 10.1186/s12888-014-0285-9.
Reference Type
BACKGROUND
Kooistra LC, Wiersma JE, Ruwaard J, van Oppen P, Smit F, Lokkerbol J, Cuijpers P, Riper H. Blended vs. face-to-face cognitive behavioural treatment for major depression in specialized mental health care: study protocol of a randomized controlled cost-effectiveness trial. BMC Psychiatry. 2014 Oct 18;14:290. doi: 10.1186/s12888-014-0290-z.
Reference Type
BACKGROUND
Thompson SC, Schlehofer MM. The many sides of control motivation for high, low and illusory control. Shah JY, Gardner WL, editors. Handbook of motivation science. New York: Guilford Press; 2008, pp 41-56.
Reference Type
BACKGROUND
Wright JH, Wright AS, Albano AM, Basco MR, Goldsmith LJ, Raffield T, Otto MW. Computer-assisted cognitive therapy for depression: maintaining efficacy while reducing therapist time. Am J Psychiatry. 2005 Jun;162(6):1158-64. doi: 10.1176/appi.ajp.162.6.1158.
Reference Type
BACKGROUND
Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.
Reference Type
BACKGROUND
Reid SC, Kauer SD, Hearps SJ, Crooke AH, Khor AS, Sanci LA, Patton GC. A mobile phone application for the assessment and management of youth mental health problems in primary care: a randomised controlled trial. BMC Fam Pract. 2011 Nov 29;12:131. doi: 10.1186/1471-2296-12-131.
Reference Type
BACKGROUND
Proudfoot J, Parker G, Hadzi Pavlovic D, Manicavasagar V, Adler E, Whitton A. Community attitudes to the appropriation of mobile phones for monitoring and managing depression, anxiety, and stress. J Med Internet Res. 2010 Dec 19;12(5):e64. doi: 10.2196/jmir.1475.
Reference Type
BACKGROUND
Cooper J, Steeg S, Bennewith O, Lowe M, Gunnell D, House A, Hawton K, Kapur N. Are hospital services for self-harm getting better? An observational study examining management, service provision and temporal trends in England. BMJ Open. 2013 Nov 19;3(11):e003444. doi: 10.1136/bmjopen-2013-003444.
Reference Type
BACKGROUND
Olfson M, Marcus SC, Bridge JA. Emergency treatment of deliberate self-harm. Arch Gen Psychiatry. 2012 Jan;69(1):80-8. doi: 10.1001/archgenpsychiatry.2011.108. Epub 2011 Sep 5.
Reference Type
BACKGROUND
Hickey L, Hawton K, Fagg J, Weitzel H. Deliberate self-harm patients who leave the accident and emergency department without a psychiatric assessment: a neglected population at risk of suicide. J Psychosom Res. 2001 Feb;50(2):87-93. doi: 10.1016/s0022-3999(00)00225-7.
Reference Type
BACKGROUND
Schull M, Vermeulen T, Stukel T, Fisher E. Follow-up and shared care following discharge from the Emergency Department for exacerbations of chronic disease. Can J Emerg Med. 2013; 13(Suppl 1):LOP05
Reference Type
BACKGROUND
Schoen C, Osborn R, Squires D, Doty M, Rasmussen P, Pierson R, Applebaum S. A survey of primary care doctors in ten countries shows progress in use of health information technology, less in other areas. Health Aff (Millwood). 2012 Dec;31(12):2805-16. doi: 10.1377/hlthaff.2012.0884. Epub 2012 Nov 15.
Reference Type
BACKGROUND
Tyrer P, Thompson S, Schmidt U, Jones V, Knapp M, Davidson K, Catalan J, Airlie J, Baxter S, Byford S, Byrne G, Cameron S, Caplan R, Cooper S, Ferguson B, Freeman C, Frost S, Godley J, Greenshields J, Henderson J, Holden N, Keech P, Kim L, Logan K, Manley C, MacLeod A, Murphy R, Patience L, Ramsay L, De Munroz S, Scott J, Seivewright H, Sivakumar K, Tata P, Thornton S, Ukoumunne OC, Wessely S. Randomized controlled trial of brief cognitive behaviour therapy versus treatment as usual in recurrent deliberate self-harm: the POPMACT study. Psychol Med. 2003 Aug;33(6):969-76. doi: 10.1017/s0033291703008171.
Reference Type
BACKGROUND
Hatcher S, Sharon C, Parag V, Collins N. Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial. Br J Psychiatry. 2011 Oct;199(4):310-6. doi: 10.1192/bjp.bp.110.090126. Epub 2011 Aug 4.
Reference Type
BACKGROUND
Akbari A, Mayhew A, Al-Alawi MA, Grimshaw J, Winkens R, Glidewell E, Pritchard C, Thomas R, Fraser C. Interventions to improve outpatient referrals from primary care to secondary care. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD005471. doi: 10.1002/14651858.CD005471.pub2.
Reference Type
BACKGROUND
Suicide Prevention Resource Center. Caring for adult patients with suicide risk: A consensus guide for emergency departments [Internet]. Waltham (MA): Education Development Center Inc.; 2015 [cited 2017 Feb 20]. Available from: http://www.sprc.org/sites/default/files/EDGuide_full.pdf
Reference Type
BACKGROUND
Suicide Prevention Resource Center. Preventing suicide among men in the middle years: Recommendations for suicide prevention programs [Internet]. Waltham (MA): Education Development Center Inc.; 2016 [cited 2017 Feb 20]. Available from: http://www.sprc.org/sites/default/files/resource-program/SPRC_MiMYReportFinal_0.pdf
Reference Type
BACKGROUND
Carroll R, Metcalfe C, Gunnell D. Hospital management of self-harm patients and risk of repetition: systematic review and meta-analysis. J Affect Disord. 2014 Oct;168:476-83. doi: 10.1016/j.jad.2014.06.027. Epub 2014 Jun 21.
Reference Type
BACKGROUND
Canadian Coalition for Seniors' Mental Health. National guidelines for seniors' mental health: The assessment of suicide risk and prevention of suicide. [Internet] Toronto: Canadian Coalition for Seniors' Mental Health; c2006 [cited 2017 Feb 20] Available from: https://ccsmh.ca/wp-content/uploads/2016/03/NatlGuideline_Suicide.pdf
Reference Type
BACKGROUND
Andreasson K, Krogh J, Rosenbaum B, Gluud C, Jobes DA, Nordentoft M. The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial. Trials. 2014 May 29;15:194. doi: 10.1186/1745-6215-15-194.
Reference Type
BACKGROUND
Andreasson K, Krogh J, Wenneberg C, Jessen HK, Krakauer K, Gluud C, Thomsen RR, Randers L, Nordentoft M. EFFECTIVENESS OF DIALECTICAL BEHAVIOR THERAPY VERSUS COLLABORATIVE ASSESSMENT AND MANAGEMENT OF SUICIDALITY TREATMENT FOR REDUCTION OF SELF-HARM IN ADULTS WITH BORDERLINE PERSONALITY TRAITS AND DISORDER-A RANDOMIZED OBSERVER-BLINDED CLINICAL TRIAL. Depress Anxiety. 2016 Jun;33(6):520-30. doi: 10.1002/da.22472. Epub 2016 Feb 8.
Reference Type
BACKGROUND
Morthorst B, Krogh J, Erlangsen A, Alberdi F, Nordentoft M. Effect of assertive outreach after suicide attempt in the AID (assertive intervention for deliberate self harm) trial: randomised controlled trial. BMJ. 2012 Aug 22;345:e4972. doi: 10.1136/bmj.e4972.
Reference Type
BACKGROUND
Moulton LH. Covariate-based constrained randomization of group-randomized trials. Clin Trials. 2004;1(3):297-305. doi: 10.1191/1740774504cn024oa.
Reference Type
BACKGROUND
Ukoumunne OC, Thompson SG. Analysis of cluster randomized trials with repeated cross-sectional binary measurements. Stat Med. 2001 Feb 15;20(3):417-33. doi: 10.1002/1097-0258(20010215)20:33.0.co;2-g.
Reference Type
BACKGROUND
Gold MR, Seigel JE, Russell LB, Weinstein MC, editors. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
Reference Type
BACKGROUND
Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies. 4th Ed. [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; c2017 [cited 2017 May 11] Available from: https://www.cadth.ca/guidelines-economic-evaluation-health-technologies-canada-4th-edition
Reference Type
BACKGROUND
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E; ISPOR Health Economic Evaluation Publication Guidelines-CHEERS Good Reporting Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013 Mar-Apr;16(2):231-50. doi: 10.1016/j.jval.2013.02.002.
Reference Type
BACKGROUND
Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.
Reference Type
BACKGROUND
Canadian Institutes of Health Research, Natural Science and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council. Tri-council policy statement: Ethical conduct for research involving humans. [Internet] Ottawa: Government of Canada; c2014 [cited 2017 May 11] Available from: www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
Reference Type
BACKGROUND
Schaffer A, Sinyor M, Kurdyak P, Vigod S, Sareen J, Reis C, Green D, Bolton J, Rhodes A, Grigoriadis S, Cairney J, Cheung A. Population-based analysis of health care contacts among suicide decedents: identifying opportunities for more targeted suicide prevention strategies. World Psychiatry. 2016 Jun;15(2):135-45. doi: 10.1002/wps.20321.
Reference Type
BACKGROUND
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTO-0790-A
Identifier Type: -
Identifier Source: org_study_id