Psychoeducational Course for Suicide Prevention
NCT Number: NCT06466356
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide Prevention|Suicide Threat|Self Efficacy|Stress, Psychological|Psychiatric Emergency|Psychiatric Disorder
Interventions: OTHER: Psychoeducational Course for Suicide Prevention|OTHER: Individual therapy session|OTHER: Treatment as usual
Sponsor: St. Olavs Hospital
Collaborators: Helse Nord-Trøndelag HF|Norwegian University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2031-12-31
Locations: Helse Nord-Trøndelag, Levanger, Trøndelag, 7600, Norway|St. Olav Hospital, Trondheim, Trøndelag, 7006, Norway

Summary:
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.

Primary Outcome Measures: 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., Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Secondary Outcome Measures: 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., Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.|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, Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.|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, Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.|Numbers of suicide attempts, Suicide attempts recorded in the Norwegian Patient Registry (NPR)., At 6, 12, 24 and 60 months after the completion of the course/individual sessions.|Numbers of suicides, Suicides recorded from the Norwegian Cause of Death Registry, At 6, 12, 24 and 60 months after the completion of the course/individual sessions.|Number of admittances in psychiatric hospital, Admittances in psychiatric hospital recorded from Norwegian Patient Registry (NPR)., At 6, 12, 24 and 60 months after the completion of the course/individual sessions.|Number of days in psychiatric hospital, Days in psychiatric hospital recorded from Norwegian Patient Registry (NPR)., At 6, 12, 24 and 60 months after the completion of the course/individual sessions.|Number of compulsory admissions, Compulsory admissions recorded from Norwegian Patient Registry (NPR)., At 6, 12, 24 and 60 months after the completion of the course/individual sessions.|Number of voluntary admissions, Voluntary admissions recorded from Norwegian Patient Registry (NPR)., At 6, 12, 24 and 60 months after the completion of the course/individual sessions.