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 emergency departments in Ontario.
Blended care
Cognitive behaviour therapy
Men
Problem-solving therapy
Self-harm
Suicide
Suicide prevention
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
13 Nov 2020
13 Nov 2020
Historique:
received:
03
03
2020
accepted:
16
05
2020
entrez:
14
11
2020
pubmed:
15
11
2020
medline:
22
6
2021
Statut:
epublish
Résumé
Patients who present to emergency departments after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by suicide in Ontario. One way of potentially addressing this gap is to offer a course of blended problem-solving therapy, comprised of a brief course of evidence-based psychotherapy for individuals at risk for suicide, facilitated by the use of a patient-facing smartphone application and a clinician-facing "dashboard." This approach has the potential to combine the benefits of face-to-face therapy and technology to create a novel intervention. This is a cohort study nested within a larger pragmatic multicentre pre- and post-design cluster randomised trial. Suicidal ideation assessed by the Beck Scale for Suicide Ideation is the primary outcome variable. Secondary outcome measures include depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory-Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data. A process evaluation will also be conducted following study completion. The cohort study will test whether better adherence to the intervention results in better outcomes. The value of the cohort study design is that we can examine in more detail certain subgroups or other variables that are not available in the larger cluster randomised trial. This trial will aim to improve standards by informing best practice in management of men who self-harm and present to hospitals in Ontario. ClinicalTrials.gov , NCT03473535 . Registered on March 22, 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Patients who present to emergency departments after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by suicide in Ontario. One way of potentially addressing this gap is to offer a course of blended problem-solving therapy, comprised of a brief course of evidence-based psychotherapy for individuals at risk for suicide, facilitated by the use of a patient-facing smartphone application and a clinician-facing "dashboard." This approach has the potential to combine the benefits of face-to-face therapy and technology to create a novel intervention.
METHODS
METHODS
This is a cohort study nested within a larger pragmatic multicentre pre- and post-design cluster randomised trial. Suicidal ideation assessed by the Beck Scale for Suicide Ideation is the primary outcome variable. Secondary outcome measures include depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory-Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data. A process evaluation will also be conducted following study completion.
DISCUSSION
CONCLUSIONS
The cohort study will test whether better adherence to the intervention results in better outcomes. The value of the cohort study design is that we can examine in more detail certain subgroups or other variables that are not available in the larger cluster randomised trial. This trial will aim to improve standards by informing best practice in management of men who self-harm and present to hospitals in Ontario.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov , NCT03473535 . Registered on March 22, 2018.
Identifiants
pubmed: 33187542
doi: 10.1186/s13063-020-04424-w
pii: 10.1186/s13063-020-04424-w
pmc: PMC7663866
doi:
Banques de données
ClinicalTrials.gov
['NCT03473535']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
925Subventions
Organisme : Ontario SPOR Support Unit
ID : IA2014-405046
Références
Trials. 2016 Aug 03;17(1):387
pubmed: 27488181
Emerg Med J. 2011 Jun;28(6):467-71
pubmed: 20660941
Am J Psychiatry. 2011 Dec;168(12):1266-77
pubmed: 22193671
J Epidemiol Community Health. 2012 Nov;66(11):1037-42
pubmed: 22523342
Psychiatr Serv. 2003 Aug;54(8):1149-54
pubmed: 12883144
J Subst Abuse Treat. 2007 Mar;32(2):189-98
pubmed: 17306727
Crisis. 2018 Jul;39(4):283-293
pubmed: 29256267
BMJ. 2002 Dec 14;325(7377):1374-5
pubmed: 12480830
Br J Psychiatry. 2011 Oct;199(4):310-6
pubmed: 21816868
J Clin Psychiatry. 2003 Jul;64(7):767-74
pubmed: 12934976
Evid Based Ment Health. 2017 Nov;20(4):118-122
pubmed: 29030503
BMC Psychiatry. 2014 Dec 14;14:355
pubmed: 25496393
JAMA Psychiatry. 2015 Jun;72(6):570-5
pubmed: 25830811
Health Rep. 2011 Sep;22(3):15-22
pubmed: 22106785
PLoS One. 2018 Feb 7;13(2):e0191405
pubmed: 29415016
PLoS One. 2014 Feb 28;9(2):e89944
pubmed: 24587141
Suicide Life Threat Behav. 2001 Winter;31(4):386-96
pubmed: 11775714
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Behav Modif. 1987 Apr;11(2):123-36
pubmed: 3508379
Psychol Med. 2006 Mar;36(3):397-405
pubmed: 16403244
JAMA Psychiatry. 2014 May;71(5):566-72
pubmed: 24671165
Acad Emerg Med. 2004 Feb;11(2):136-42
pubmed: 14759954
BMJ. 2015 Mar 19;350:h1258
pubmed: 25791983
Suicide Life Threat Behav. 1987 Spring;17(1):33-49
pubmed: 3590270
J Epidemiol Community Health. 2003 Apr;57(4):238-40
pubmed: 12646535
J Psychosom Res. 2002 Sep;53(3):819-22
pubmed: 12217457
J R Coll Physicians Lond. 1994 Jul-Aug;28(4):370-1
pubmed: 7965981
J Pers Assess. 1990 Winter;55(3-4):610-7
pubmed: 2280326
Int J Epidemiol. 2007 Dec;36(6):1229-34
pubmed: 17905808
Br J Psychiatry. 2002 Sep;181:193-9
pubmed: 12204922