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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2017
Source University of Ottawa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
CHESS Mobile Health smart phone application
A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Behavioral:
Problem solving therapy
Face to face problem solving therapy every week for six weeks.

Locations

Country Name City State
Canada The Ottawa Hospital - Civic Campus Ottawa Ontario
Canada The Ottawa Hospital - General Campus Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (16)

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Outcome

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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