Suicide Clinical Trial
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
Verified date | September 2023 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | September 23, 2024 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa | Ottawa Hospital Research Institute |
Canada,
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
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. — View Citation
Allen NB. Cognitive therapy of depression. Aaron T Beck, A John Rush, Brian F Shaw, Gary Emery. New York: Guilford Press, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):275-8. doi: 10.1046/j.1440-1614.2002.t01-5-01015.x. No abstract available. — View Citation
Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N, Fishman T, Falloon K, Hatcher S. Validation of PHQ-2 and PHQ-9 to screen for major depression in the primary care population. Ann Fam Med. 2010 Jul-Aug;8(4):348-53. doi: 10.1370/afm.1139. — View Citation
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
Bethell J, Rhodes AE. Identifying deliberate self-harm in emergency department data. Health Rep. 2009 Jun;20(2):35-42. — View Citation
Bisconer SW, Gross DM. Assessment of suicide risk in a psychiatric hospital. Prof Psychol Res Pr. 2007; 38(2), 143-149.
Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, Hakkaart-van Roijen L. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013 Jun 15;13:217. doi: 10.1186/1472-6963-13-217. — View Citation
Brannon R, Juni S. A scale for measuring attitudes about masculinity. Psychological Documents. 1984; 14 (Doc.#2612).
Carey KB, Carey MP, Chandra PS. Psychometric evaluation of the alcohol use disorders identification test and short drug abuse screening test with psychiatric patients in India. J Clin Psychiatry. 2003 Jul;64(7):767-74. doi: 10.4088/jcp.v64n0705. — View Citation
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. — View Citation
Cheng AT, Hawton K, Lee CT, Chen TH. The influence of media reporting of the suicide of a celebrity on suicide rates: a population-based study. Int J Epidemiol. 2007 Dec;36(6):1229-34. doi: 10.1093/ije/dym196. Epub 2007 Sep 28. — View Citation
Clum, G. A., & Yang, B. (1995). Additional support for the reliability and validity of the Modified Scale for Suicide Ideation. Psychological Assessment, 7(1), 122-125. https://doi.org/10.1037/1040-3590.7.1.122.
Cocco, K. M., & Carey, K. B. (1998). Psychometric properties of the Drug Abuse Screening Test in psychiatric outpatients. Psychological Assessment, 10(4), 408-414. https://doi.org/10.1037/1040-3590.10.4.408.
Cochrane-Brink KA, Lofchy JS, Sakinofsky I. Clinical rating scales in suicide risk assessment. Gen Hosp Psychiatry. 2000 Nov-Dec;22(6):445-51. doi: 10.1016/s0163-8343(00)00106-7. — View Citation
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. — View Citation
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. — View Citation
D'Zurilla TJ, Nezu AM. Development and preliminary evaluation of the Social Problem-Solving Inventory. Psychol Assess. 1990; 2(2), 156-163.
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. — View Citation
Eisler RM, Skidmore JR. Masculine gender role stress. Scale development and component factors in the appraisal of stressful situations. Behav Modif. 1987 Apr;11(2):123-36. doi: 10.1177/01454455870112001. No abstract available. — View Citation
Eynan R, Shah R, Heisel MJ, Eden D, Jhirad R, Links PS. The Feasibility and Clinical Utility of Conducting a Confidential Inquiry Into Suicide in Southwestern Ontario. Crisis. 2018 Jul;39(4):283-293. doi: 10.1027/0227-5910/a000500. Epub 2017 Dec 19. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hawton K, Williams K. Influences of the media on suicide. BMJ. 2002 Dec 14;325(7377):1374-5. doi: 10.1136/bmj.325.7377.1374. No abstract available. — View Citation
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. — View Citation
Health Canada. (2010). Acting on what we know: Preventing youth suicide in First Nations. Retrieved December 1, 2017, from http://www.hc-sc.gc.ca/fniah- spnia/pubs/promotion/_suicide/prev_youth-jeunes/index-eng.php#tphp.
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.
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.
Heisel, M. J. (2009). Assessing experienced meaning in life among older adults:The development and initial validation of the EMIL. International Psychogeriatrics, 21(S2), S172-173.
Heisel, M. J., & Duberstein, P. R. (2016). Working sensitively and effectively to reduce suicide risk among older adults. (P. M. Kleespies, Ed.)The Oxford Handbook of Behavioural Emergencies and Crises (Vol. 1). Oxford University Press https://doi.org/10.1093/oxfordhb/9780199352722.013.25
Heisel, M. J., & Flett, G. L. (2008). Psychological resilience to suicide ideation among older adults. Clinical Gerontologist, 31(4), 51-70. https://doi.org/10.1080/07317110801947177.
Hewitt PL, Flett GL, Weber C. Dimensions of perfectionism and suicide ideation. Cogn Ther Res. 1994; 18(5), 439-460.
Hewitt, P. L., Flett, G. L., & Weber, C. (1994). Dimensions of perfectionism and suicide ideation. Cognitive Therapy and Research (Vol. 18). Retrieved from https://journals-scholarsportal-info.proxy.bib.uottawa.ca/pdf/00057967/v31i0002/229_dosiipi.xml.
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. — View Citation
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
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation
Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatr Ann. 2002; 32(9), 509-515.
Kroenke, K., & Spitzer, R. L. (2002). The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals, 32(9), 509-515. https://doi.org/10.3928/0048- 5713-20020901-06.
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.
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. — View Citation
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258. — View Citation
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. — View Citation
Niederkrotenthaler T, Fu KW, Yip PS, Fong DY, Stack S, Cheng Q, Pirkis J. Changes in suicide rates following media reports on celebrity suicide: a meta-analysis. J Epidemiol Community Health. 2012 Nov;66(11):1037-42. doi: 10.1136/jech-2011-200707. Epub 2012 Apr 21. — View Citation
O'Connor E, Gaynes BN, Burda BU, Soh C, Whitlock EP. Screening for and treatment of suicide risk relevant to primary care: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 May 21;158(10):741-54. doi: 10.7326/0003-4819-158-10-201305210-00642. — View Citation
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.
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. — View Citation
Ostamo A, Lonnqvist J. Excess mortality of suicide attempters. Soc Psychiatry Psychiatr Epidemiol. 2001 Jan;36(1):29-35. doi: 10.1007/s001270050287. — View Citation
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. — View Citation
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. — View Citation
Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. J Gen Intern Med. 2016 Oct;31(10):1206-11. doi: 10.1007/s11606-016-3703-5. Epub 2016 May 11. — View Citation
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. — View Citation
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
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. — View Citation
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x. — View Citation
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. — View Citation
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
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/
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation
Stack S. Media coverage as a risk factor in suicide. J Epidemiol Community Health. 2003 Apr;57(4):238-40. doi: 10.1136/jech.57.4.238. — View Citation
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
Steer RA, Rissmiller DJ, Ranieri WF, Beck AT. Dimensions of suicidal ideation in psychiatric inpatients. Behav Res Ther. 1993 Feb;31(2):229-36. doi: 10.1016/0005-7967(93)90090-h. — View Citation
Suicide Prevention Resource Center. (2015). Caring for adult patients with suicide risk: A consensus guide for emergency departments. Waltham, MA: Education Development Center, Inc.
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
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59. — View Citation
Thompson, S. C., & Schlehofer, M. M. (2008). The many sides of control motivation: Motives for high, low, and illusory control. In J. Y. Shah & W. L. Gardner (Eds.), Handbook of motivation science. (pp. 41-56). New York, NY, US: The Guilford Press.
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. — View Citation
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. — View Citation
Yudko E, Lozhkina O, Fouts A. A comprehensive review of the psychometric properties of the Drug Abuse Screening Test. J Subst Abuse Treat. 2007 Mar;32(2):189-98. doi: 10.1016/j.jsat.2006.08.002. Epub 2006 Nov 21. — View Citation
Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2.
* Note: There are 82 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Severity of Depression Symptoms - 9-Item Patient Health Questionnaire (PHQ-9) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Severity of Anxiety Symptoms - 7-Item General Anxiety Disorder Questionnaire (GAD-7) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Post-Traumatic Stress Disorder Symptoms - 5-Item Primary Care Post-Traumatic Stress Disorder Screening Tool for DSM-5 (PC-PTSD-5) | Self-reported questionnaire assessing the presence of PTSD-related symptoms. The questionnaire consists of five 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-5 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment | |
Secondary | Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) | 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." | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Meaning in Life - 40-Item Experienced Meaning in Life Questionnaire (EMIL): Four sub-scales (Creative, Experiential, Attitudinal, Ultimate) | 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. Higher scores reflect greater perceived meaning in life. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Perceived Social Supports - 12-Item Multidimensional Scale of Perceived Social Supports (MSPSS) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Alcohol Misuse - 3-Item Alcohol Use Disorder Identification Test (AUDIT-C) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Alcohol Misuse - 10-Item Alcohol Use Disorder Identification Test (AUDIT) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Drug Misuse - 10-Item Drug-Abuse Screening Test (DAST-10) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Emotional Control Sub-Scale | 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. | Baseline Visit | |
Secondary | Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Self-Reliance Sub-Scale | 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. | Baseline Visit | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Previous Hospitalizations for Self-Harm | 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. | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentation to Hospital for Self-Harm | 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. | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentations to the Hospital for Any Reason Other Than Self-Harm | 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." | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Admission to the Hospital for Any Reason. | 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." | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Outpatient Appointment for Any Reason. | 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." | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Primary Care Visits. | 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." | 6 months Post-Enrollment. | |
Secondary | Problem-Solving Skills - 25-Item Social Problem Solving Inventory - Revised Short Form (SPSI-R:S) | 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. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Health Service Use - Questionnaire on Healthcare Consumption and Productivity losses for patients with a Psychiatric Disorder (TiC-P) | Health service use (healthcare consumption) and work productivity will be captured using the TiC-P. The TiC-P is a 29-item self-report questionnaire taking less than 10 minutes to complete. Some items have been removed or modified from the original TiC-P including optional items as noted by the developers, items captured elsewhere in a more reliable manner (such as current medications or demographics), or items adapted to better describe services in Ontario healthcare system. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04127292 -
Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Recruiting |
NCT05423483 -
Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents
|
Phase 2 | |
Completed |
NCT03272048 -
Identifying Effective Approaches to Counseling on Firearm Safety
|
N/A | |
Completed |
NCT05514587 -
Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
|
||
Enrolling by invitation |
NCT05639426 -
Preventing Youth Violence Through Building Equitable Communities
|
N/A | |
Completed |
NCT03703128 -
Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
|
||
Completed |
NCT03646903 -
Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk
|
N/A | |
Not yet recruiting |
NCT05558332 -
Youth Nominated Support Team
|
N/A | |
Not yet recruiting |
NCT06349915 -
A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
|
N/A | |
Completed |
NCT02718248 -
Ottawa Suicide Prevention in Men Pilot Study
|
N/A | |
Completed |
NCT02094898 -
Ketamine for Depression and Suicide Risk
|
Phase 2 | |
Completed |
NCT01360736 -
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
|
N/A | |
Completed |
NCT01594138 -
Linguistic Characteristics of Suicidal Patients in the Emergency Department
|
N/A | |
Completed |
NCT02228044 -
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment
|
N/A | |
Completed |
NCT00604097 -
Preventing Youth Suicide in Primary Care: A Family Model
|
Phase 3 | |
Completed |
NCT00387855 -
An Evaluation of the SOS (Suicide Prevention) Program
|
N/A | |
Recruiting |
NCT03519802 -
Evaluation of Cognitive Function in a Suicidal Crisis
|
||
Completed |
NCT05580757 -
Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
|
||
Recruiting |
NCT03030924 -
Wearable Suicidal Early Warning System for Adolescents
|