Suicide Clinical Trial
— OSSUPilotOfficial title:
Pilot Study of a Smart Phone Assisted Problem Solving Therapy for Men Who Have Presented With Intentional Self-harm to Emergency Departments
NCT number | NCT02718248 |
Other study ID # | 20150765-01H |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | June 2017 |
Verified date | November 2017 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | June 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital - Civic Campus | Ottawa | Ontario |
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa |
Canada,
Canadian Institute for Health Information (2011) Health Indicators 2011. Canadian Institute for Health Information,, Ottawa, Ontario
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. Review. — View Citation
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. — View Citation
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
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
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, 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. — View Citation
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. — 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
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, Träskman-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. Review. — 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. 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. Epub 2006 Jan 10. — View Citation
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. — View Citation
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. — View Citation
National Institute for Health and Clinical Excellence (2011) Longer-term care and treatment of self-harm. vol CG133.
Owens D, Horrocks J, House A. Fatal and non-fatal repetition of self-harm. Systematic review. Br J Psychiatry. 2002 Sep;181:193-9. Review. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Recruitment Rates at 6 Months | Will be used to assess the feasibility of recruitment for a larger, multicentre cluster randomized controlled trial (RCT). To test feasibility in patients the investigators aim to recruit at least half of the men the study team ask to take part in the pilot study. To test feasibility in referring clinicians, the aim is that at least half of men who present with intentional self-harm to the psychiatric emergency service will be approached and complete the The Ottawa Hospital (TOH) form allowing contact details to be passed on to researchers. | Within 6 months of study launch | |
Primary | 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 | Physical Functioning | Physical Functioning was measured using the Physical Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Functioning Subscale is scored using a range of 0-100, with a higher score indicating better physical functioning. | Baseline and Week 5 | |
Secondary | Physical Role Limitations | Physical Role Limitations was measured using the Physical Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to physical health difficulties. | Baseline, Week 5 | |
Secondary | Emotional Role Limitations | Emotional Role Limitations was measured using the Emotional Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Emotional Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to emotional health difficulties. | Baseline, Week 5 | |
Secondary | Vitality | Vitality was measured using the Vitality subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Vitality subscale is scored using a range of 0-100, with a higher score indicating a higher degree of vitality. | Baseline, Week 5 | |
Secondary | General Health | General Health was measured using the General Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The General Health Subscale is scored using a range of 0-100, with a higher score indicating higher levels of general health. | Baseline, Week 5 | |
Secondary | Mental Health Functioning | Mental Health Functioning was measured using the Mental Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Mental Health Functioning Subscale is scored using a range of 0-100, with a higher score indicating better mental health functioning. | Baseline, Week 5 | |
Secondary | Bodily Pain | Bodily Pain was measured using the Bodily Pain subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Bodily Pain Subscale is scored using a range of 0-100, with a higher score indicating lower levels of bodily pain. | Baseline, Week 5 | |
Secondary | Social Functioning | Social Functioning was measured using the Social Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Social Functioning Subscale is scored using a range of 0-100, with a higher score indicating higher social functioning. | Baseline, Week 5 | |
Secondary | Health-Related Quality of Life | Generic health-related quality of life index. The total scores on this measure range from 11111 to 33333, with lower values indicating higher levels of health-related quality of life. | Baseline and Week 5 | |
Secondary | Perceived Overall Health | Participants were asked to use the EuroQol 5 Dimensions Visual Analytic Scale to assess their overall health on a scale from 0 to 100, with 100 being the best possible health state. | Baseline, Week 5 | |
Secondary | Participant Exit Questionnaire | The investigators will ask participants about the user comprehension, user practicality and the methods of data collection with regards to the CHESS Mobile Health smart phone application. The Participant Exit Questionnaire will also ask that users make comments or suggestions for future use and development of the application. This will test the acceptability of the intervention and the acceptability of using routine data sources as outcome measures. | within 4 months of study completion |
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