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Trial record 5 of 149 for:    BEACON

The BEACON Study: Smartphone-Assisted Problem-solving Therapy in Men Presenting to the ED With Self-Harm (Protocol B)

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ClinicalTrials.gov Identifier: NCT03473535
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Dr. Simon Hatcher, University of Ottawa

Brief Summary:
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 cohort component of this study will use data collected from consenting participants who presented to an intervention site's Emergency Department for self-harm. This data will be gathered over the course of six PST sessions, during a "booster" session occurring six months after the final therapy session, and at one year post-enrollment.

Condition or disease Intervention/treatment Phase
Intentional Self-Harm Suicide Combination Product: Smartphone Assisted PST Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The BEACON Study: Protocol for a Cohort Study as Part of an Evaluation of the Effectiveness of Smartphone-assisted Problem-solving Therapy in Men Who Present With Intentional Self-harm to the ED in Ontario (Protocol B)
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Smartphone Assisted PST
Emergency departments providing the option to refer men who self-harm to a service that will deliver smartphone-assisted PST.
Combination Product: Smartphone Assisted PST
6 sessions of face-to-face PST delivered by a trained Research Therapist and access to the BEACON Suicide Prevention smartphone application, as well as a "booster" session of PST at six months.
Other Name: BEACON Intervention



Primary Outcome Measures :
  1. Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS) [ Time Frame: Time Frame: Baseline - Session 6 (weekly); 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported measurement of the current intensity of a participant's attitudes, behaviours, and plans to die by suicide during the past week. It consists of 5 screening items, and 19 follow-up items. Each item is scored from 0 (moderate to strong) to 2 (none), yielding a total score ranging from 0 to 48, with higher scores indicating a higher risk of suicidality. Generally, scores above 24 are considered to be a clinical cutoff implying that the respondent is at significant risk for suicide.


Secondary Outcome Measures :
  1. Change in Severity of Depression Symptoms - 9-Item Patient Health Questionnaire (PHQ-9) [ Time Frame: Time Frame: Baseline - Session 6 (weekly); 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported measurement of the severity of depression symptoms experienced within the last two weeks. The survey consists of 9 items. Participants are asked to rate each symptom of depression on a Likert scale, providing a score between 0 (not at all) and 3 (nearly every day). This yields a total score ranging from 0 (minimal depression) to 27 (severe depression). Higher scores thus indicate a greater severity of depressive symptoms, and are interpreted in the following manner: a score of 0-4 indicates minimal depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, a score of 15-19 indicates moderately severe depression, and a score of 20-27 indicates severe depression.

  2. Change in Severity of Anxiety Symptoms - 7-Item General Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: Time Frame: Baseline - Session 6 (weekly); 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported measurement of the severity of anxiety symptoms experienced within the last two weeks. It consists of 7 scored items and one follow-up question. Each of the 7 scored items generates a value from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating more severe symptoms of anxiety. These scores are interpreted in the following manner: a score of 0-4 indicates little or no anxiety, a score of 5-9 indicates mild anxiety, a score of 10-14 indicates moderate anxiety, and a score of 15-21 indicates severe anxiety. Generally, a score of 10 or above is considered to be a clinical cutoff implying that the respondent may be suffering from a general anxiety disorder.

  3. Change in Post-Traumatic Stress Disorder Symptoms - 4-Item Primary Care Post-Traumatic Stress Disorder Screening Tool (PC-PTSD-4) [ Time Frame: Time Frame: Baseline - Session 6 (weekly); 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing the presence of PTSD-related symptoms. The questionnaire consists of four items requiring a 'yes' or 'no' response. The result of the questionnaire is either 'positive' or 'negative' based on the number of 'yes' responses indicated. The authors suggest that the results of the PC-PTSD survey should be considered 'positive' if three or more yes responses are indicated. A 'positive' result on this questionnaire suggests that the respondent has probable PTSD.

  4. Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing 5 health-related dimensions relevant to quality of life. These dimensions consist of mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression. Each dimension consists of 5 items, which are ranked by means of a Likert scale from 1 to 5. A score of 1 in a given dimension indicates no problems for that dimension of health, a score of 2 indicates slight problems for dimension, a score of 3 indicates moderate problems for that dimension, a score of 4 indicates severe problems for that dimension, and a score of 5 indicates extreme problems for that dimension. Respondent decisions result in a 1 digit number expressing the level selected for that dimension. The digits for these five dimensions are combined, resulting in a five digit number, and indicating one of 3,125 possible health states. This five digit number has no arithmetic properties, and is not used as a cardinal score.

  5. Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing health-related quality of life, including mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression. It consists of 5 items, which are ranked by means of a Likert scale from 1 to 5. Respondents fall into one of 3,125 different health states depending on their responses to the questionnaire. The measure also includes a Visual Analogue Scale (VAS) which asks participants to evaluate their overall health on a scale from 0-100. Higher scores on the VAS scale indicate a better state of general health, with a score of 100 suggesting the "best imaginable health state" and a score of 0 suggesting the "worst imaginable health state."

  6. Change in Meaning in Life - 40-Item Experienced Meaning in Life Questionnaire (EMIL): 10-Item Creative Sub-Scale [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing a participant's perceived meaning in life. The full EMIL survey consists of four 10-item sub-scales rated on a Likert scale, with each item generating a number between 1 (strongly disagree) to 5 (strongly agree). This produces a total score ranging from 40 to 200. For the purposes of this study, the investigators will be using only the Creative and Attitudinal sub-scales in order to reduce the burden on participants and investigators. The creative sub-scale produces a score between 10 and 50, with higher scores indicating greater perceived meaning in life as regards creativity.

  7. Change in Meaning in Life - 40-Item Experienced Meaning in Life Questionnaire (EMIL) Attitudinal Sub-Scale [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing a participant's perceived meaning in life. The full EMIL survey consists of four 10-item sub-scales rated on a Likert scale, with each item generating a number between 1 (strongly disagree) to 5 (strongly agree). This produces a total score ranging from 40 to 200. For the purposes of this study, the investigators will be using only the Creative and Attitudinal sub-scales in order to reduce the burden on participants and investigators. The attitudinal sub-scale produces a score between 10 and 50, with higher scores indicating greater perceived meaning in life as regards respondent attitude towards success and failures.

  8. Change in Perceived Social Supports - 12-Item Multidimensional Scale of Perceived Social Supports (MSPSS) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing a respondents perceived level of social supports available. It consists of 12 items rated on a seven-point Likert scale, generating scores between 1 (very strongly disagree) and 7 (very strongly agree). Items are arranged into three subscales (Significant Other, Family, and Friends) consisting of four items each. Mean scores are generated for each sub-scale by adding the values together and dividing by four. A total value is generated by adding together all values and dividing by 12, resulting in a mean scale score between 1 and 7, with higher scores indicating a higher level of perceived social support. These scores can be interpreted in the following manner: a score between 1 and 2.9 could be considered low support, a score between 3 and 5 can be considered moderate support, and a score from 5.1 to 7 can be considered high support.

  9. Change in Alcohol Misuse - 3-Item Alcohol Use Disorder Identification Test (AUDIT-C) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing alcohol consumption, drinking behaviour, adverse reactions, and alcohol-related problems. Two versions of the AUDIT questionnaire will be used in this study. The 3 item version (AUDIT-C) will be employed as a screening questionnaire, and the full 10 item version employed as a follow-up questionnaire. Each of the 10 items generates a score between 0 (never) and 4 (daily or almost daily), with a total score generated by summing the values. The AUDIT-C survey generates a score between 0 and 12, with higher scores indicating a greater risk of alcoholism. Given that higher scores act as an indicator that respondents have problems with alcohol, participants with a score of above 4 on the AUDIT-C will be asked to complete the full questionnaire.

  10. Change in Alcohol Misuse - 10-Item Alcohol Use Disorder Identification Test (AUDIT) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing alcohol consumption, drinking behaviour, adverse reactions, and alcohol-related problems. Two versions of the AUDIT questionnaire will be used in this study. The 3 item version (AUDIT-C) will be employed as a screening questionnaire, and the full 10 item version employed as a follow-up questionnaire. Each of the 10 items generates a score between 0 (never) and 4 (daily or almost daily), with a total score generated by summing the values. Scoring on the full AUDIT questionnaire generates a total ranging between 0 and 40, with higher scores acting as an indicator that respondents have problems with alcohol. AUDIT scores of 8 or above are recommended as indicators of hazardous and harmful alcohol use. A score of between 8 and 15 represents a medium level of alcohol problems, and a score of 16 or above represents a high level of alcohol problems.

  11. Change in Drug Misuse - 10-Item Drug-Abuse Screening Test (DAST-10) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing drug abuse within the last 12 months. It consists of 10 items requiring a 'yes' or 'no' response. Each response indicating a possible drug-use problem is awarded one point. Total scores range between 0 and 10, with higher scores acting as an indicator that the respondent has a substance abuse problem. A score of 0 suggests no problems, a score of 1-2 suggests a low level of drug abuse problems, a score of 3-5 suggests a moderate level of drug abuse problems, a score of 6-8 suggests a substantial level of drug abuse problems, and a score of 9-10 suggests a severe level of drug abuse problems.

  12. Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Emotional Control Sub-Scale [ Time Frame: Baseline Visit ]
    Self-reported questionnaire assessing a participant's personal conformity with masculine gender norms. The full CMNI questionnaire consists of 94 items rated on a four-point Likert scale, generating scores between 1 (strongly disagree) and 4 (strongly agree). This produces a total score ranging between 94 and 376. For the purposes of this study, the investigators will only be using the Emotional Control (CMNI-EC) and Self-Reliance (CMNI-SR) sub-scales in order to reduce the burden on participants and study staff. The emotional control sub-scale consists of 12 questions, and generates a score between 12 and 48, with higher scores indicating greater conformity to masculine norms as regards emotion.

  13. Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Self-Reliance Sub-Scale [ Time Frame: Baseline Visit ]
    Self-reported questionnaire assessing a participant's personal conformity with masculine gender norms. The full CMNI questionnaire consists of 94 items rated on a four-point Likert scale, generating scores between 1 (strongly disagree) and 4 (strongly agree). This produces a total score ranging between 94 and 376. For the purposes of this study, the investigators will only be using the Emotional Control (CMNI-EC) and Self-Reliance (CMNI-SR) sub-scales in order to reduce the burden on participants and study staff. The self-reliance sub-scale consists of 12 questions, and generates a score between 12 and 48, with higher scores indicating greater conformity to masculine norms as regards self-reliance.

  14. Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Previous Hospitalizations for Self-Harm [ Time Frame: Time Frame: 1 Year Post-Enrollment. ]
    Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. This particular outcome item refers to "previous hospitalizations for self-harm". The incidence of previous hospitalizations for self-harm will be measured using the ICD-10-CM codes T360-T50992, T510-T6592, T71112-T71232, and X71-X83.

  15. Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentation to Hospital for Self-Harm [ Time Frame: Time Frame: 1 Year Post-Enrollment. ]
    Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. This particular outcome item refers to "presentation to hospital for self-harm". The incidence of presentations to hospital for self-harm will be measured using the ICD-10-CM codes T360-T50992, T510-T6592, T71112-T71232, and X71-X83.

  16. Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentations to the Hospital for Any Reason Other Than Self-Harm [ Time Frame: Time Frame: 1 Year Post-Enrollment. ]
    Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Presentations to the Hospital for any Reason Other Than Self-Harm."

  17. Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Admission to the Hospital for Any Reason. [ Time Frame: Time Frame: 1 Year Post-Enrollment. ]
    Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Admission to the Hospital for Any Reason."

  18. Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Outpatient Appointment for Any Reason. [ Time Frame: Time Frame: 1 Year Post-Enrollment. ]
    Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Outpatient Appointment for Any Reason."

  19. Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Primary Care Visits. [ Time Frame: Time Frame: 1 Year Post-Enrollment. ]
    Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Primary Care Visits."

  20. Problem-Solving Skills - 25-Item Social Problem Solving Inventory - Revised Short Form (SPSI-R:S) [ Time Frame: Time Frame: Baseline; Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire assessing the impact of the intervention (smartphone-assisted Problem Solving Therapy) on a participants social problem solving skills. The questionnaire consists of 25 items and 5 scales (positive problem orientation, rational problem-solving style, negative problem orientation, impulsivity/carelessness style, and avoidance style). Participants are asked to choose one of five possible responses for each item, generating a score between 0 and 4. This yields a total score ranging between 0 and 100, with higher scores indicating an individual with more effective problem-solving skills.

  21. Health Care Costs Questionnaire - Elements From the Client Service Receipt Inventory (CSRI) and the Work Productivity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) [ Time Frame: Time Frame: Session 6; 6 Month Booster Session; 1 Year Post-Enrollment. ]
    Self-reported questionnaire developed by the research team assessing health service use in order to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of collecting this data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants who identify as male will be eligible for participation in the trial.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Identifies as Male.
  • 18 years of age or older.
  • Has presented via the Emergency Department with self-harm.
  • Able to read and understand English, French or Oji Cree.
  • Willing to attend six problem-solving therapy sessions for a period of six weeks.
  • Willing to use a smartphone application to facilitate the treatment of self-harm.
  • Willing to return to hospital for follow-up appointments.
  • Willing and able to provide informed consent.
  • In the opinion of the investigator is likely to commit to a one-year long study.

Exclusion Criteria:

  • Identifies as female.
  • Is under 18 years of age.
  • Has presented to the Emergency Department for a reason other than self-harm.
  • Is unable to read and understand English, French or Oji Cree.
  • Is unwilling to attend six problem-solving therapy sessions for a period of six weeks.
  • Is unwilling or unable to use a smartphone application to facilitate the treatment of self--harm.
  • Is unwilling to return to hospital for follow-up appointments.
  • Is unwilling or unable to provide informed consent.
  • In the opinion of the investigator is unlikely to commit to a one-year long study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473535


Contacts
Contact: Simon Hatcher, MD 613-798-5555 ext 73011 shatcher@uottawa.ca
Contact: Anna Rogic, MA 613-737-8899 ext 81209 spresearch@uottawa.ca

Locations
Canada, Ontario
The Ottawa Hospital - General Campus Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Simon Hatcher, MD    613-798-5555 ext 73011    shatcher@uottawa.ca   
Contact: Anna Rogic, MA    613-737-8899 ext 81209    spresearch@uottawa.ca   
Sponsors and Collaborators
University of Ottawa
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Simon Hatcher, PhD University of Ottawa
Principal Investigator: Marnin Heisel, PhD University of Western Ontario, Canada
  Study Documents (Full-Text)

Documents provided by Dr. Simon Hatcher, University of Ottawa:
Study Protocol  [PDF] December 6, 2017


Publications:
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/
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
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.
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
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
Accurate: 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
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
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
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.
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
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
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
Beck AT. Cognitive therapy of depression. New York: Guilford Press; 1979.
Clum GA, Yang B. Additional support for the reliability and validity of the Modified Scale for Suicide Ideation. Psychol Assess. 1995; 7(1): 122-125.
Hewitt PL, Flett GL, Weber C. Dimensions of perfectionism and suicide ideation. Cogn Ther Res. 1994; 18(5), 439-460.
Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatr Ann. 2002; 32(9), 509-515.
Prins A, Ouimette P, Kimerling R, Cameron RP, Hugelshofer D, Shaw-Hegwer J, et al. The primary care PTSD screen (PC-PTSD): Development and operating characteristics. Primary Care Psychiatry. 2003; 9(1): 9-14.
Heisel MJ, Flett GL. Psychological resilience to suicide ideation among older adults. Clin Gerontol. 2008; 31(4), 439-640.
Heisel MJ. Assessing experienced meaning in life among older adults: The development and initial validation of the EMIL. Int Psychogeriatr. 2009; 21 (Supplement 2), S172-S173.
Mahalik JR, Locke BD, Ludlow LH, Diemer MA, Scott RP, Gottfried M, et al. Development of the conformity to masculine norms inventory. Psychol Men Masc. 2003; 4(1), 3-25.
Brannon R, Juni S. A scale for measuring attitudes about masculinity. Psychological Documents. 1984; 14 (Doc.#2612).
O'Neil JM, Helms BJ, Gable RK, David L, Wrightsman LS. Gender-role conflict scale: College men's fear of femininity. Sex Roles. 1986; 14(5), 335-350.
D'Zurilla TJ, Nezu AM. Development and preliminary evaluation of the Social Problem-Solving Inventory. Psychol Assess. 1990; 2(2), 156-163.
Bisconer SW, Gross DM. Assessment of suicide risk in a psychiatric hospital. Prof Psychol Res Pr. 2007; 38(2), 143-149.

Responsible Party: Dr. Simon Hatcher, Vice-Chair, Department of Psychiatry, University of Ottawa
ClinicalTrials.gov Identifier: NCT03473535     History of Changes
Other Study ID Numbers: CTO-0790-B
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Simon Hatcher, University of Ottawa:
self-harm
problem-solving therapy
emergency department
e-therapy
suicide prevention

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms