About this trial
The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a suicide attempt, suicidal behavior, or risk of suicidal behavior and a clinician evaluating that the patient has an intention to die
Patients with a suicide attempt or suicidal behavior defined as "a self-inflicted, potentially injurious behavior with a non-fatal outcome for which there is evidence of intention of death and/or considered to have had or been close to a suicidal crisis syndrome.
Disqualifiers
Not being sufficiently fluent in Norwegian to provide informed consent, valid responses on psychometric testing or to benefit from a psychoeducative course.
A known diagnosis of ICD-10 F 60.3 (borderline personality disorder) with similar symptoms at previous admittances.
Ongoing psychosis.
A substance abuse condition to such a degree that they are unable to comply with the protocol and are considered to be at risk when attending psychoeducational courses.
Trial design
Parallel
Treatments tested in this trial
Psychoeducational Course for Suicide Prevention
Other interventionBaseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months.
Individual therapy session
Other interventionBaseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months.
Treatment as usual
Other interventionTreatment as usual (TAU) may include the use of psychotropic drugs, in and out-patient treatment, occupational therapy and other interventions the patients physician deem necessary.
Treatment groups
Trial outcomes
Primary outcomes
Self efficacy
The General self-efficacy scale (GSE) measures optimistic self-beliefs in coping with the demands, tasks and challenges of life in general. It consists of 10 statements that respondents rate on a scale from 1 (not at all true) to 4 (exactly true). The individual's scores on each item are summed up to a GSE score with higher scores indicating higher GSE. Questions regarding the perceived efficacy regarding handling future episodes of increased suicide is added. An increase of ≥ 5 points on the GSE scale is considered the limit for a minimally clinically important change.
Secondary outcomes
Mental pain
The mental pain questionnaire (MPQ). The MPQ includes statements on sense of emptiness, loss of meaning and suffering. The statements are formulated on a dichotomous response format. Higher scores indicate higher level of mental pain. MPQ is a simple 10-items self-rating questionnaire and is a transdiagnostic tool. Minimum score 0, maximum score 10.
Symptoms of depression
Symptoms measured by Patient Health Questionnaire (PHQ-9). The nine-item PHQ-9 is a depressive symptom scale. Scores range from minimum 0 to maximum 27. Higher scores indicate a worse outcome
Symptoms of anxiety
The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity of anxiety. Scores range from minimum 0 to maximum 21. Higher scores indicate a worse outcome
Numbers of suicide attempts
Suicide attempts recorded in the Norwegian Patient Registry (NPR).
Sponsors and contacts
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St. Olavs Hospital
Lead sponsor
Helse Nord-Trøndelag HF
Collaborator
Norwegian University of Science and Technology
Collaborator