Trial Outcomes & Findings for Ottawa Suicide Prevention in Men Pilot Study (NCT NCT02718248)
NCT ID: NCT02718248
Last Updated: 2018-08-20
Results Overview
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.
COMPLETED
NA
7 participants
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
2018-08-20
Participant Flow
Participant recruitment took place over a 6 month period from Sept. 2016 to Feb. 2017. TOH ED staff were asked to approach participants with information about the study and refer any eligible men to the Research Coordinator. Once participants were referred to the Research Coordinator, she contacted them by telephone and scheduled a Baseline Visit.
No participants were excluded from this study post-enrollment.
Participant milestones
| Measure |
CHESS Mobile Health Group
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=7 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=7 Participants
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Age, Categorical
>=65 years
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0 Participants
n=7 Participants
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Age, Continuous
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27.43 years
STANDARD_DEVIATION 8.142 • n=7 Participants
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Sex: Female, Male
Female
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0 Participants
n=7 Participants
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Sex: Female, Male
Male
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7 Participants
n=7 Participants
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Region of Enrollment
Canada
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7 participants
n=7 Participants
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Severity of Depression Symptoms
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18.29 units on a scale
STANDARD_DEVIATION 5.529 • n=7 Participants
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Physical Functioning
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82.14 units on a scale
STANDARD_DEVIATION 18.898 • n=7 Participants
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Physical Role Limitations
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75 units on a scale
STANDARD_DEVIATION 23.936 • n=7 Participants
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Emotional Role Limitations
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26.79 units on a scale
STANDARD_DEVIATION 26.446 • n=7 Participants
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Vitality
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25.0 units on a scale
STANDARD_DEVIATION 20.412 • n=7 Participants
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General Health
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42.14 units on a scale
STANDARD_DEVIATION 29.277 • n=7 Participants
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Mental Health Functioning
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17.86 units on a scale
STANDARD_DEVIATION 17.466 • n=7 Participants
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Bodily Pain
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71.43 units on a scale
STANDARD_DEVIATION 30.375 • n=7 Participants
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Social Functioning
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28.57 units on a scale
STANDARD_DEVIATION 22.493 • n=7 Participants
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General Health Related Quality of Life
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11223 units on a scale
n=7 Participants
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EuroQol 5 Dimensions Visual Analytic Scale
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47.57 units on a scale
STANDARD_DEVIATION 11.530 • n=7 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5Population: Throughout the course of the study, the following study time points were missed: Week 1 (2 participants), Week 3 (1 participant) and Week 4 (1 participant).
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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Week 1
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19.8 units on a scale
Standard Deviation 5.07
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Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Week 2
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15.17 units on a scale
Standard Deviation 5.565
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Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Week 3
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16.86 units on a scale
Standard Deviation 6.619
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Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Week 4
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16.83 units on a scale
Standard Deviation 6.853
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Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Week 5
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13.71 units on a scale
Standard Deviation 9.995
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SECONDARY outcome
Timeframe: Baseline and Week 5Physical 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Physical Functioning
Baseline
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82.14 units on a scale
Standard Deviation 18.898
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Physical Functioning
Week 5
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92.86 units on a scale
Standard Deviation 18.898
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SECONDARY outcome
Timeframe: Baseline, Week 5Physical 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Physical Role Limitations
Baseline
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75.0 units on a scale
Standard Deviation 23.936
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Physical Role Limitations
Week 5
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83.93 units on a scale
Standard Deviation 18.70
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SECONDARY outcome
Timeframe: Baseline, Week 5Emotional 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Emotional Role Limitations
Baseline
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26.79 units on a scale
Standard Deviation 26.446
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Emotional Role Limitations
Week 5
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44.64 units on a scale
Standard Deviation 25.877
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SECONDARY outcome
Timeframe: Baseline, Week 5Vitality 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Vitality
Baseline
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25.00 units on a scale
Standard Deviation 20.412
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Vitality
Week 5
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46.43 units on a scale
Standard Deviation 33.63
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SECONDARY outcome
Timeframe: Baseline, Week 5General 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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General Health
Baseline
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42.14 units on a scale
Standard Deviation 29.277
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General Health
Week 5
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48.57 units on a scale
Standard Deviation 23.755
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SECONDARY outcome
Timeframe: Baseline, Week 5Mental 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Mental Health Functioning
Baseline
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17.86 units on a scale
Standard Deviation 17.466
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Mental Health Functioning
Week 5
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30.36 units on a scale
Standard Deviation 21.478
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SECONDARY outcome
Timeframe: Baseline, Week 5Bodily 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Bodily Pain
Baseline
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71.43 units on a scale
Standard Deviation 30.375
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Bodily Pain
Week 5
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82.14 units on a scale
Standard Deviation 18.898
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SECONDARY outcome
Timeframe: Baseline, Week 5Social 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Social Functioning
Baseline
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28.57 units on a scale
Standard Deviation 22.493
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Social Functioning
Week 5
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35.71 units on a scale
Standard Deviation 19.67
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SECONDARY outcome
Timeframe: Baseline and Week 5Generic 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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Health-Related Quality of Life
Week 5
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11313 units on a scale
Interval 11111.0 to 22223.0
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Health-Related Quality of Life
Baseline
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11223 units on a scale
Interval 11113.0 to 21223.0
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SECONDARY outcome
Timeframe: Baseline, Week 5Participants 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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Perceived Overall Health
Baseline
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47.57 units on a scale
Standard Deviation 11.53
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Perceived Overall Health
Week 5
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60.29 units on a scale
Standard Deviation 14.795
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SECONDARY outcome
Timeframe: within 4 months of study completionThe 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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=7 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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Participant Exit Questionnaire
Application Easy to Install
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100.0 percentage of participants who agreed
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Participant Exit Questionnaire
Application is User Friendly
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85.7 percentage of participants who agreed
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Participant Exit Questionnaire
Application was easy to use
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71.4 percentage of participants who agreed
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Participant Exit Questionnaire
PST is a good fit for me
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71.4 percentage of participants who agreed
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Participant Exit Questionnaire
In PST we worked on what I wanted
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85.7 percentage of participants who agreed
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Participant Exit Questionnaire
Application was useful
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28.6 percentage of participants who agreed
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Participant Exit Questionnaire
I would use the application again
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42.9 percentage of participants who agreed
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OTHER_PRE_SPECIFIED outcome
Timeframe: Within 6 months of study launchPopulation: This group includes all participants referred to the study (N=15).
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.
Outcome measures
| Measure |
CHESS Mobile Health Group
n=15 Participants
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Recruitment Rates at 6 Months
|
46.6 percentage of participants enrolled
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Adverse Events
CHESS Mobile Health Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CHESS Mobile Health Group
n=7 participants at risk
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.
CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Problem solving therapy: Face to face problem solving therapy every week for six weeks.
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|---|---|
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Injury, poisoning and procedural complications
Subsequent Self-Harm
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42.9%
3/7 • Number of events 4 • 6 weeks
Adverse events related to subsequent self-harm were collected from participants by their therapist at each study visit.
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Infections and infestations
Tooth Abscess
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14.3%
1/7 • Number of events 1 • 6 weeks
Adverse events related to subsequent self-harm were collected from participants by their therapist at each study visit.
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Injury, poisoning and procedural complications
Trip
|
14.3%
1/7 • Number of events 1 • 6 weeks
Adverse events related to subsequent self-harm were collected from participants by their therapist at each study visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place