N/A
N=7
Ottawa Suicide Prevention in Men Pilot Study
Suicide
Bottom Line
View on ClinicalTrials.gov: NCT02718248 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 — 19.8; 15.17; 16.86; 16.83 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHESS Mobile Health smart phone application (Device); Problem solving therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Ottawa
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 |
19.8; 15.17; 16.86; 16.83; 13.71 | — |
| SECONDARY Physical Functioning |
82.14; 92.86 | — |
| SECONDARY Physical Role Limitations |
75.0; 83.93 | — |
| SECONDARY Emotional Role Limitations |
26.79; 44.64 | — |
| SECONDARY Vitality |
25.00; 46.43 | — |
| SECONDARY General Health |
42.14; 48.57 | — |
| SECONDARY Mental Health Functioning |
17.86; 30.36 | — |
| SECONDARY Bodily Pain |
71.43; 82.14 | — |
| SECONDARY Social Functioning |
28.57; 35.71 | — |
| SECONDARY Health-Related Quality of Life |
11223; 11313 | — |
| SECONDARY Perceived Overall Health |
47.57; 60.29 | — |
| SECONDARY Participant Exit Questionnaire |
100.0; 85.7; 71.4; 71.4; 85.7; 28.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02718248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.