Suicide Clinical Trial
Official title:
The BEACON Study: Protocol for a Pilot Randomized Controlled Trial of Smartphone-assisted Problem Solving Therapy in Men Who Present With Intentional Self-harm to Emergency Departments in Ontario
Verified date | September 2023 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the use of problem-solving therapy (PST), supplemented by a smartphone application, in the treatment of men who present to the Emergency Departments in Ontario. A total of 100 men in 5 Emergency Departments will be enrolled and randomized to receive either face-to-face PST or face-to-face PST supplemented by the BEACON Suicide Prevention smartphone application. Face-to-face therapy may be provided via videoconference to accommodate patient preference and ongoing pandemic restrictions. Participants will complete six sessions of PST and outcomes will be measured at baseline, 6 weeks, two post-therapy follow-up time points (3 and 6 months). Participants will also be asked to complete a qualitative interview about their participation in the study and their experience with the smartphone application.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | September 23, 2024 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Identifies as Male. - 18 years of age or older. - Has presented via the Emergency Department with self-harm in the preceding 4 weeks - Able to read and understand English, French or read or understand Oji Cree. - Willing to attend six problem-solving therapy sessions for a period of up to eight weeks. - Willing to use a smartphone application to facilitate the treatment of self-harm. - Willing to return to the hospital for follow-up appointments. - Willing and able to provide informed consent. - Willing to use e-mail for study activities. Exclusion Criteria: - Identifies as female. - Has presented to the Emergency Department for a reason other than self-harm. - In the opinion of the investigator is unlikely to commit to a six-month long study. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa | Ottawa Hospital Research Institute |
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* Note: There are 82 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS) | Self-reported measurement of the current intensity of a participant's attitudes, behaviours, and plans to die by suicide during the past week. It consists of 5 screening items, and 19 follow-up items. Each item is scored from 0 (moderate to strong) to 2 (none), yielding a total score ranging from 0 to 48, with higher scores indicating a higher risk of suicidality. Generally, scores above 24 are considered to be a clinical cutoff implying that the respondent is at significant risk for suicide. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Severity of Depression Symptoms - 9-Item Patient Health Questionnaire (PHQ-9) | Self-reported measurement of the severity of depression symptoms experienced within the last two weeks. The survey consists of 9 items. Participants are asked to rate each symptom of depression on a Likert scale, providing a score between 0 (not at all) and 3 (nearly every day). This yields a total score ranging from 0 (minimal depression) to 27 (severe depression). Higher scores thus indicate a greater severity of depressive symptoms, and are interpreted in the following manner: a score of 0-4 indicates minimal depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, a score of 15-19 indicates moderately severe depression, and a score of 20-27 indicates severe depression. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Severity of Anxiety Symptoms - 7-Item General Anxiety Disorder Questionnaire (GAD-7) | Self-reported measurement of the severity of anxiety symptoms experienced within the last two weeks. It consists of 7 scored items and one follow-up question. Each of the 7 scored items generates a value from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating more severe symptoms of anxiety. These scores are interpreted in the following manner: a score of 0-4 indicates little or no anxiety, a score of 5-9 indicates mild anxiety, a score of 10-14 indicates moderate anxiety, and a score of 15-21 indicates severe anxiety. Generally, a score of 10 or above is considered to be a clinical cutoff implying that the respondent may be suffering from a general anxiety disorder. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Post-Traumatic Stress Disorder Symptoms - 5-Item Primary Care Post-Traumatic Stress Disorder Screening Tool for DSM-5 (PC-PTSD-5) | Self-reported questionnaire assessing the presence of PTSD-related symptoms. The questionnaire consists of five items requiring a 'yes' or 'no' response. The result of the questionnaire is either 'positive' or 'negative' based on the number of 'yes' responses indicated. The authors suggest that the results of the PC-PTSD-5 survey should be considered 'positive' if three or more yes responses are indicated. A 'positive' result on this questionnaire suggests that the respondent has probable PTSD. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) | Self-reported questionnaire assessing 5 health-related dimensions relevant to quality of life. These dimensions consist of mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression. Each dimension consists of 5 items, which are ranked by means of a Likert scale from 1 to 5. A score of 1 in a given dimension indicates no problems for that dimension of health, a score of 2 indicates slight problems for dimension, a score of 3 indicates moderate problems for that dimension, a score of 4 indicates severe problems for that dimension, and a score of 5 indicates extreme problems for that dimension. Respondent decisions result in a 1 digit number expressing the level selected for that dimension. The digits for these five dimensions are combined, resulting in a five digit number, and indicating one of 3,125 possible health states. This five digit number has no arithmetic properties, and is not used as a cardinal score. | Baseline; Session 6; 3 months; 6 months Post-Enrollment | |
Secondary | Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) | Self-reported questionnaire assessing health-related quality of life, including mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression. It consists of 5 items, which are ranked by means of a Likert scale from 1 to 5. Respondents fall into one of 3,125 different health states depending on their responses to the questionnaire. The measure also includes a Visual Analogue Scale (VAS) which asks participants to evaluate their overall health on a scale from 0-100. Higher scores on the VAS scale indicate a better state of general health, with a score of 100 suggesting the "best imaginable health state" and a score of 0 suggesting the "worst imaginable health state." | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Meaning in Life - 40-Item Experienced Meaning in Life Questionnaire (EMIL): Four sub-scales (Creative, Experiential, Attitudinal, Ultimate) | Self-reported questionnaire assessing a participant's perceived meaning in life. The full EMIL survey consists of four 10-item sub-scales rated on a Likert scale, with each item generating a number between 1 (strongly disagree) to 5 (strongly agree). This produces a total score ranging from 40 to 200. Higher scores reflect greater perceived meaning in life. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Perceived Social Supports - 12-Item Multidimensional Scale of Perceived Social Supports (MSPSS) | Self-reported questionnaire assessing a respondents perceived level of social supports available. It consists of 12 items rated on a seven-point Likert scale, generating scores between 1 (very strongly disagree) and 7 (very strongly agree). Items are arranged into three subscales (Significant Other, Family, and Friends) consisting of four items each. Mean scores are generated for each sub-scale by adding the values together and dividing by four. A total value is generated by adding together all values and dividing by 12, resulting in a mean scale score between 1 and 7, with higher scores indicating a higher level of perceived social support. These scores can be interpreted in the following manner: a score between 1 and 2.9 could be considered low support, a score between 3 and 5 can be considered moderate support, and a score from 5.1 to 7 can be considered high support. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Alcohol Misuse - 3-Item Alcohol Use Disorder Identification Test (AUDIT-C) | Self-reported questionnaire assessing alcohol consumption, drinking behaviour, adverse reactions, and alcohol-related problems. Two versions of the AUDIT questionnaire will be used in this study. The 3 item version (AUDIT-C) will be employed as a screening questionnaire, and the full 10 item version employed as a follow-up questionnaire. Each of the 10 items generates a score between 0 (never) and 4 (daily or almost daily), with a total score generated by summing the values. The AUDIT-C survey generates a score between 0 and 12, with higher scores indicating a greater risk of alcoholism. Given that higher scores act as an indicator that respondents have problems with alcohol, participants with a score of above 4 on the AUDIT-C will be asked to complete the full questionnaire. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Alcohol Misuse - 10-Item Alcohol Use Disorder Identification Test (AUDIT) | Self-reported questionnaire assessing alcohol consumption, drinking behaviour, adverse reactions, and alcohol-related problems. Two versions of the AUDIT questionnaire will be used in this study. The 3 item version (AUDIT-C) will be employed as a screening questionnaire, and the full 10 item version employed as a follow-up questionnaire. Each of the 10 items generates a score between 0 (never) and 4 (daily or almost daily), with a total score generated by summing the values. Scoring on the full AUDIT questionnaire generates a total ranging between 0 and 40, with higher scores acting as an indicator that respondents have problems with alcohol. AUDIT scores of 8 or above are recommended as indicators of hazardous and harmful alcohol use. A score of between 8 and 15 represents a medium level of alcohol problems, and a score of 16 or above represents a high level of alcohol problems. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Change in Drug Misuse - 10-Item Drug-Abuse Screening Test (DAST-10) | Self-reported questionnaire assessing drug abuse within the last 12 months. It consists of 10 items requiring a 'yes' or 'no' response. Each response indicating a possible drug-use problem is awarded one point. Total scores range between 0 and 10, with higher scores acting as an indicator that the respondent has a substance abuse problem. A score of 0 suggests no problems, a score of 1-2 suggests a low level of drug abuse problems, a score of 3-5 suggests a moderate level of drug abuse problems, a score of 6-8 suggests a substantial level of drug abuse problems, and a score of 9-10 suggests a severe level of drug abuse problems. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Emotional Control Sub-Scale | Self-reported questionnaire assessing a participant's personal conformity with masculine gender norms. The full CMNI questionnaire consists of 94 items rated on a four-point Likert scale, generating scores between 1 (strongly disagree) and 4 (strongly agree). This produces a total score ranging between 94 and 376. For the purposes of this study, the investigators will only be using the Emotional Control (CMNI-EC) and Self-Reliance (CMNI-SR) sub-scales in order to reduce the burden on participants and study staff. The emotional control sub-scale consists of 12 questions, and generates a score between 12 and 48, with higher scores indicating greater conformity to masculine norms as regards emotion. | Baseline Visit | |
Secondary | Adherence to Masculine Gender Roles - 94-Item Conformity to Masculine Norms Scale (CMNI): Self-Reliance Sub-Scale | Self-reported questionnaire assessing a participant's personal conformity with masculine gender norms. The full CMNI questionnaire consists of 94 items rated on a four-point Likert scale, generating scores between 1 (strongly disagree) and 4 (strongly agree). This produces a total score ranging between 94 and 376. For the purposes of this study, the investigators will only be using the Emotional Control (CMNI-EC) and Self-Reliance (CMNI-SR) sub-scales in order to reduce the burden on participants and study staff. The self-reliance sub-scale consists of 12 questions, and generates a score between 12 and 48, with higher scores indicating greater conformity to masculine norms as regards self-reliance. | Baseline Visit | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Previous Hospitalizations for Self-Harm | Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. This particular outcome item refers to "previous hospitalizations for self-harm". The incidence of previous hospitalizations for self-harm will be measured using the ICD-10-CM codes T360-T50992, T510-T6592, T71112-T71232, and X71-X83. | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentation to Hospital for Self-Harm | Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Presentations to the Hospital for Any Reason Other Than Self-Harm | Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Presentations to the Hospital for any Reason Other Than Self-Harm." | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Admission to the Hospital for Any Reason. | Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Admission to the Hospital for Any Reason." | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Outpatient Appointment for Any Reason. | Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Outpatient Appointment for Any Reason." | 6 months Post-Enrollment. | |
Secondary | Health Service Use - Data from the Institute for Clinical Evaluative Sciences (ICES): Primary Care Visits. | Health service use will be captured using routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES). Data to be collected includes: previous hospitalizations for self-harm, presentation to hospital for self-harm, presentations to hospital for any reason other than self-harm, admission to hospital for any reason, outpatient appointment for any reason, and primary care visits. A questionnaire has also been created by the research team to capture data not available in ICES. Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) have been integrated for the purposes of gathering the above-listed data. This particular outcome item refers to "Primary Care Visits." | 6 months Post-Enrollment. | |
Secondary | Problem-Solving Skills - 25-Item Social Problem Solving Inventory - Revised Short Form (SPSI-R:S) | Self-reported questionnaire assessing the impact of the intervention (smartphone-assisted Problem Solving Therapy) on a participants social problem solving skills. The questionnaire consists of 25 items and 5 scales (positive problem orientation, rational problem-solving style, negative problem orientation, impulsivity/carelessness style, and avoidance style). Participants are asked to choose one of five possible responses for each item, generating a score between 0 and 4. This yields a total score ranging between 0 and 100, with higher scores indicating an individual with more effective problem-solving skills. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. | |
Secondary | Health Service Use - Questionnaire on Healthcare Consumption and Productivity losses for patients with a Psychiatric Disorder (TiC-P) | Health service use (healthcare consumption) and work productivity will be captured using the TiC-P. The TiC-P is a 29-item self-report questionnaire taking less than 10 minutes to complete. Some items have been removed or modified from the original TiC-P including optional items as noted by the developers, items captured elsewhere in a more reliable manner (such as current medications or demographics), or items adapted to better describe services in Ontario healthcare system. | Baseline; Session 6; 3 months; 6 months Post-Enrollment. |
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