- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466356
Psychoeducational Course for Suicide Prevention
Psychoeducational Course for Suicide Prevention - a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Trøndelag
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Levanger, Trøndelag, Norway, 7600
- Helse Nord-Trøndelag
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Trondheim, Trøndelag, Norway, 7006
- St. Olav Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psychoeducational group therapy
Group therapy session, 3 meetings.
Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU.
|
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 (TAU) may include the use of psychotropic drugs, in and out-patient treatment, occupational therapy and other interventions the patients physician deem necessary.
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Active Comparator: Individual therapy session
The participants in the control group receive one individual therapy session with focus on suicide risk and safety plan with a psychologist or physician and TAU
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self efficacy
Time Frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
|
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.
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Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental pain
Time Frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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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.
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Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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Symptoms of depression
Time Frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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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
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Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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Symptoms of anxiety
Time Frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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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
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Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
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Numbers of suicide attempts
Time Frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Suicide attempts recorded in the Norwegian Patient Registry (NPR).
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At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Numbers of suicides
Time Frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Suicides recorded from the Norwegian Cause of Death Registry
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At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Number of admittances in psychiatric hospital
Time Frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Admittances in psychiatric hospital recorded from Norwegian Patient Registry (NPR).
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At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Number of days in psychiatric hospital
Time Frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Days in psychiatric hospital recorded from Norwegian Patient Registry (NPR).
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At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Number of compulsory admissions
Time Frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Compulsory admissions recorded from Norwegian Patient Registry (NPR).
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At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Number of voluntary admissions
Time Frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Voluntary admissions recorded from Norwegian Patient Registry (NPR).
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At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katrine K Fjukstad, PhD, Helse Nord Trøndelag
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 142708
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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