Psychoeducational Course for Suicide Prevention

Stress, Psychological Clinical Trial

Official title:

Psychoeducational Course for Suicide Prevention - a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06466356
• Other study ID #: 142708
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: December 31, 2031

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be included during admittance in the acute psychiatric ward or when in contact with the outpatient team for acute and emergency psychiatry. They will receive acute treatment and be placed on a waiting list until enough patients are included to start the intervention. Then the included patients will be randomized to either the psychoeducational course or the individual session. The course and the individual lessons start at the same time. Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU.

The first session (2x45 min) focus on information on suicidal thoughts, mental pain, suicide attempts and suicide as a phenomenon with focus on vulnerability factors, risk development and development of the suicidal crisis syndrome. The second session (2x45 min) tackles identifying triggers for increase in suicide risk and suicidal impulses, detecting early warning signals for increased suicide risk and how to recognize the change as it happens. In the third session (3x45 min) patients work on completing the individual safety plan to prevent an increase in suicide risk. The plan includes "situations that may trigger increased risk", "how to recognize and communicate the increased risk" and "actions that may reduce or increase risk." Finally, the fourth and last session (2x45 min) is aimed at the next of kin that the group participant wants to attend. Patients do not attend this session. The next of kin receive a review of the information from the first two sessions, as well as focus on what the next of kin can or cannot do to help if the risk of suicide increases.

The control group receive one individual session with focus on suicide risk and safety plan with a psychologist or physician and TAU.

Randomization and masking of study groups Participants will be equally randomized (1:1) in the intervention and control group. Patients will be included during admittance in the acute psychiatric ward or when in contact with the outpatient team for acute and emergency psychiatry. The first randomization takes place when sixteen to twenty participants are included. Randomization will take place by manual randomization by an external person at the Research department at St. Olav Hospital in Trondheim. This ensures an equal distribution between the intervention group and the control group. The patient and treating clinician will be unblinded to treatment modality. To compensate for lack of blinding concerning the received treatment, the persons ratings, subsequent measurements and data collection at follow-up will be blinded to the treatment conditions to avoid confirmation bias. The statistical advisor will also be blinded to treatment modality.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Organic brain disorders or mental disabilities in such a degree that they are unable to comply with the protocol.

• Not being able to give an informed consent

Related Conditions & MeSH terms

• Emergencies
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Psychiatric Emergency
• Self Efficacy
• Stress, Psychological
• Suicide
• Suicide Prevention
• Suicide Threat

Intervention

Other:
• Psychoeducational Course for Suicide Prevention
Baseline 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
Baseline 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
Treatment 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.

Locations

Country	Name	City	State
Norway	Helse Nord-Trøndelag	Levanger	Trøndelag
Norway	St. Olav Hospital	Trondheim	Trøndelag

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Helse Nord-Trøndelag HF, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.