Ottawa Suicide Prevention in Men Pilot Study (OSSUPilot)

November 8, 2017 updated by: Dr. Simon Hatcher, University of Ottawa

Pilot Study of a Smart Phone Assisted Problem Solving Therapy for Men Who Have Presented With Intentional Self-harm to Emergency Departments

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Self-harm is defined as intentional self-poisoning or self-injury, whether or not there is evidence that the act was intended to result in death. In the past, the term used was 'attempted suicide.' However, peoples' motives for harming themselves are highly variable, a person may have more than one motive and motivation is hard to assess. In line with usual public policy in health and social care, the investigators use the term 'self-harm' describing a behaviour - avoiding the word 'deliberate' because many service users or consumers dislike its connotations.

In Ontario, the number of people who present to hospital emergency departments with self-harm is difficult to accurately assess, but the best estimate is about 30,000 each year. The most common form of self-harm seen in emergency departments (around 80% of episodes) is the intentional consumption of an excess of a medicinal or toxic product, whether or not there is evidence that the act was intended to result in death. Injuries, most commonly self-cutting, form 15-20% of episodes.

Two-thirds of people attending emergency departments because of self-harm are under 35 years of age. They are high users of health and social care services. Self-harm has a strong association with suicide: 7 patients per 1000 (about 1%) die by suicide in the year after attending emergency departments with a non-fatal episode (60 times the general population risk), rising to as many as 30 patients per 1000 over the next 15 years. In a recent longitudinal study conducted at the University of Toronto, "all-cause mortality following a first episode of self-poisoning was 1107 per 100,000 person-years… [with] nearly half of all deaths being suicides, accidents or undetermined intent." About a quarter of suicides are preceded by a hospital visit due to non-fatal self-harm in the previous year. It is the major identifiable risk factor for suicide. Mortality from non-suicidal causes is also high, with significantly more than the expected numbers of deaths from natural causes and from accidents. Whilst four of ten people who present with self-harm are men, they form nearly two thirds of suicides after an episode and are far more likely than women to die of premature death from other causes. The premature deaths are greatly over-represented among young people and the life years lost to the community are many.

Repetition of non-fatal self-harm stands at around 20% annually and is associated with much distress and many unresolved interpersonal problems. It is likely that any reduction in repetition of self-harm will be mirrored by a fall in subsequent suicides. The Canadian Association for Suicide Prevention blueprint for a National Suicide Prevention Strategy (CASP) has identified those who have presented to hospital with non-fatal self-harm as a high risk target group to reduce suicide.

People attending emergency departments after self-harm receive a variable standard of care in Ontario. Many are not assessed for psychological needs, and the little psychological therapy available is not usually covered by Ontario Health Insurance (OHIP). Local data from hospitals in Ottawa show that only 4 out of 10 men who present with intentional self-harm are seen by a mental health professional. Few are offered an evidence-based treatment aimed at reducing their risk of suicide or repeated self-harm. At present, assessment for self-harm in adults in Ontario is highly variable and there is no standard protocol for therapy. Assessment of suicide risk is currently a Required Operating Practice for Canadian Hospital accreditation; however, individuals identified as at-risk for suicide rarely receive recommended care.

Specialist services offer intensive and lengthy treatment for the minority of people who self-harm diagnosed with personality disorders, such as dialectical behavior therapy or mindfulness based therapy. The evidence for the effectiveness of these specialist therapies comes almost entirely from studies in women.

The investigators have received funding for a multicentre cluster randomized trial from the Ontario Strategy for Patient Oriented Research (SPOR) Support for People and Patient Oriented Research and Trials (SUPPORT) Unit funded by Canadian Institutes for Health Research (CIHR) and the Ontario Ministries of Health and Research and Innovation (MRI) comparing the delivery of smart phone assisted problem solving therapy with treatment as usual in men who present with self-harm. The rationale for focusing on men is that most suicides are in men and previous trials have found that providing generic treatments to everyone does not work. The intervention will build on previous work by trying to extend the range and intensity of therapy. The investigators will do this by supplementing it with a sophisticated smart phone application that has already demonstrated its effectiveness in men with substance abuse disorders. The investigators will be offering an intervention specifically designed for men who self-harm, as they are hard to engage and are more likely than women to have substance abuse problems. However, before proceeding with the full trial, a pilot study will be implemented to refine the intervention and treatment manual, as well as to test the acceptability and feasibility of the intervention to patients.

The pilot study has two aims. The first is 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 primary outcome will be the change from baseline in scores on a depression rating scale the PHQ-9 at six weeks. The second aim is to test acceptability. The investigators will ask patients 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. We will also create a treatment manual for problem solving therapy that incorporates the use of a smart phone application.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital - Civic Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: CHESS Mobile Health smart phone application
A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
Other Names:
  • Addictions Comprehensive Health Enhancement Support System
  • Comprehensive Health Enhancement Support System
Behavioral: Problem solving therapy
Face to face problem solving therapy every week for six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Functioning
Time Frame: Baseline and Week 5
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
Physical Role Limitations
Time Frame: Baseline, Week 5
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
Emotional Role Limitations
Time Frame: Baseline, Week 5
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
Vitality
Time Frame: Baseline, Week 5
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
General Health
Time Frame: Baseline, Week 5
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
Mental Health Functioning
Time Frame: Baseline, Week 5
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
Bodily Pain
Time Frame: Baseline, Week 5
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
Social Functioning
Time Frame: Baseline, Week 5
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
Health-Related Quality of Life
Time Frame: Baseline and Week 5
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
Perceived Overall Health
Time Frame: Baseline, Week 5
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
Participant Exit Questionnaire
Time Frame: within 4 months of study completion
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rates at 6 Months
Time Frame: Within 6 months of study launch
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Investigators

  • Principal Investigator: Simon Hatcher, MD, PhD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150765-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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