Psychoeducational Course for Suicide Prevention

NCT ID: NCT06466356

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2031-12-31

Brief 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.

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.

Conditions

Suicide Prevention; Suicide Threat; Self Efficacy; Stress, Psychological; Psychiatric Emergency; Psychiatric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Psychoeducational Course for Suicide Prevention

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

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

Group Type: ACTIVE_COMPARATOR

Individual therapy session

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrine K Fjukstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Nord Trøndelag

Locations

Helse Nord-Trøndelag

Levanger, Trøndelag, Norway

Site Status: RECRUITING

St. Olav Hospital

Trondheim, Trøndelag, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Katrine K Fjukstad, PhD

Role: CONTACT

katrine.k.fjukstad@ntnu.no

+4774098600

Thine Rishaug, MD

Role: CONTACT

Thine.Marita.Kirkeby.Rishaug@stolav.no

Facility Contacts

Katrine Kveli K Fjukstad, PhD

Role: primary

katrine.k.fjukstad@ntnu.no

+4774098600

Thine MK Rishaug, MD

Role: backup

Thine.Marita.Kirkeby.Rishaug@stolav.no

+4772573000

Thine MK Rishaug, MD

Role: primary

Thine.Marita.Kirkeby.Rishaug@stolav.no

+4772573000

Karina S Høyen, PhD

Role: backup

Karina.Sagmo.Hoyen@stolav.no

4772573000

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

142708

Identifier Type: -

Identifier Source: org_study_id