Ottawa Suicide Prevention in Men Pilot Study

NCT02718248 | Completed Results DMC

• 1 other identifier: 20150765-01H
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

To refine a novel intervention using a combination of a smart phone application with best practice psychotherapy for men who have presented to hospital with intentional self-harm. The outcome will be change in baseline of scores on a depression rating scale the PHQ-9 at six weeks. Moreover, the investigators will ask participants about the acceptability of the intervention and the acceptability of using routine data sources as outcome measures. This will inform methods of recruitment for the larger cluster randomized controlled trial and the creation of a treatment manual.

Conditions

Suicide

Keywords

self-harm; problem-solving therapy; emergency department; e-therapy; suicide prevention

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6

  Measures change in the severity of depressive symptoms. Total scores on this scale range from 0 to 27, with higher scores indicating more severe depression symptoms. The scores on the Patient Health Questionnaire (PHQ-9) scale should be interpreted as follows: 0-4: Minimal Depression; 5-9: Mild Depression 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20 and Above: Severe Depression.

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

Secondary Outcomes (11)

• Physical Functioning

  Baseline and Week 5

• Physical Role Limitations

  Baseline, Week 5

• Emotional Role Limitations

  Baseline, Week 5

• Vitality

  Baseline, Week 5

• General Health

  Baseline, Week 5

Other Outcomes (1)

• Recruitment Rates at 6 Months

  Within 6 months of study launch

Study Arms (1)

CHESS Mobile Health Group

EXPERIMENTAL

The intervention will be six weekly one hour sessions of face-to-face problem solving therapy combined with the CHESS Mobile Health smart phone application (Comprehensive Health Enhancement Support System - CHESS). The CHESS Mobile Health smart phone application enables users to access relevant resources, create a support network and check in regularly with carers. The intervention will be delivered by Dr. Hatcher, a staff psychiatrist in Liaison Psychiatry at The Ottawa Hospital General Campus.

Device: CHESS Mobile Health smart phone application; Behavioral: Problem solving therapy

Interventions

CHESS Mobile Health smart phone application DEVICE

A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.

Also known as: Addictions Comprehensive Health Enhancement Support System, Comprehensive Health Enhancement Support System

CHESS Mobile Health Group

Problem solving therapy BEHAVIORAL

Face to face problem solving therapy every week for six weeks.

CHESS Mobile Health Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is male;
• Participant is 18 years of age or older;
• Participant has presented via Emergency Department to The Ottawa Hospital General and Civic Campuses with intentional self-harm;
• Participant is willing to return to the The Ottawa Hospital General Campus for follow-up appointments;
• Participant is willing to consent to participate in the study.

You may not qualify if:

• Participant is unable to read or understand English;
• Participant has cognitive impairments that render them incapable of using a smart phone;
• Participant does not have a smart phone and/or a smart phone with a data plan;
• Participants who in the opinion of the investigator will be unlikely to commit to a three month long study.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (2)

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (18)

• Canadian Institute for Health Information (2011) Health Indicators 2011. Canadian Institute for Health Information,, Ottawa, Ontario

  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.

  PMID: 17516016 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.

  PMID: 12204922 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.

  PMID: 25830811 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.

  PMID: 20660941 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.

  PMID: 16403244 BACKGROUND

• Caterino JM, Sullivan AF, Betz ME, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Investigators. Evaluating current patterns of assessment for self-harm in emergency departments: a multicenter study. Acad Emerg Med. 2013 Aug;20(8):807-15. doi: 10.1111/acem.12188.

  PMID: 24033624 BACKGROUND

• Hawton K, Arensman E, Townsend E, Bremner S, Feldman E, Goldney R, Gunnell D, Hazell P, van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L. Deliberate self harm: systematic review of efficacy of psychosocial and pharmacological treatments in preventing repetition. BMJ. 1998 Aug 15;317(7156):441-7. doi: 10.1136/bmj.317.7156.441.

  PMID: 9703526 BACKGROUND

• Hawton K, McKeown S, Day A, Martin P, O'Connor M, Yule J. Evaluation of out-patient counselling compared with general practitioner care following overdoses. Psychol Med. 1987 Aug;17(3):751-61. doi: 10.1017/s0033291700025988.

  PMID: 2819914 BACKGROUND

• National Institute for Health and Clinical Excellence (2011) Longer-term care and treatment of self-harm. vol CG133.

  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.

  PMID: 25128754 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.

  PMID: 21816868 BACKGROUND

• Hatcher S, Sharon C, House A, Collins N, Collings S, Pillai A. The ACCESS study: Zelen randomised controlled trial of a package of care for people presenting to hospital after self-harm. Br J Psychiatry. 2015 Mar;206(3):229-36. doi: 10.1192/bjp.bp.113.135780. Epub 2015 Jan 22.

  PMID: 25614531 BACKGROUND

• Hatcher S, Coupe N, Durie M, Elder H, Tapsell R, Wikiriwhi K, Parag V. Te Ira Tangata: a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm. Trials. 2011 May 11;12:117. doi: 10.1186/1745-6215-12-117.

  PMID: 21569300 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.

  PMID: 24671165 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 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.

  PMID: 33884617 DERIVED

• Mackie C, Dunn N, MacLean S, Testa V, Heisel M, Hatcher S. A qualitative study of a blended therapy using problem solving therapy with a customised smartphone app in men who present to hospital with intentional self-harm. Evid Based Ment Health. 2017 Nov;20(4):118-122. doi: 10.1136/eb-2017-102764. Epub 2017 Oct 13.

  PMID: 29030503 DERIVED

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior; Emergencies; Suicide Prevention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sarah MacLean
• Organization: Ottawa Hospital Research Institute

samaclean@ohri.ca

6137378899

Study Officials

• Simon Hatcher, MD, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research, Department of Psychiatry

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: March 24, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)