Clinical trial NCT06466356: Psychoeducational Course for Suicide Prevention
Official title: Psychoeducational Course for Suicide Prevention - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Prevention
Suicide Threat
Self Efficacy
Stress, Psychological
Psychiatric Emergency
Psychiatric Disorder
Keywords: Psychoeducation
Safety plan
Gatekeeper
Suicidal crisis syndrome
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
name: Norwegian University of Science and Technology
First posted: 2024-06-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients acutely admitted to Department of acute psychiatry, St Olav University Hospital (SOH) or Levanger Hospital or acutely admitted to an outpatient team for acute and emergency psychiatry, SOH, or admitted to a district psychiatric centers (DPS) in Trøndelag county or evaluated by physicians or psychologists at the Consultation Liaison, SOH. Patients will be included with consecutive sampling of patients who meet the selection criteria and give an informed consent.

Participants will be equally randomized (1:1) in the intervention and control group and randomization will take place by digital randomization using WebCRF (KlinForsk/ Klinisk forskningsenhet Midt-Norge). Stratified randomization will be used regarding the baseline variable "substance abuse", ensuring that this variable is more evenly distributed between the two groups than chance.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self efficacy
timeFrame: 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 outcomes:
measure: Mental pain
timeFrame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
measure: Symptoms of depression
timeFrame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
measure: Symptoms of anxiety
timeFrame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
measure: Numbers of suicide attempts
timeFrame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
measure: Numbers of suicides
timeFrame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
measure: Number of admittances in psychiatric hospital
timeFrame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
measure: Number of days in psychiatric hospital
timeFrame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
measure: Number of compulsory admissions
timeFrame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
measure: Number of voluntary admissions
timeFrame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Helse Nord-Trøndelag
state: Trøndelag
city: Trondheim
country: Norway
facility: St. Olav Hospital
state: Trøndelag
Study officials:
affiliation: Helse Nord Trøndelag
name: Katrine K Fjukstad, PhD
role: PRINCIPAL_INVESTIGATOR
References: