Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-03
Brief Title:
Psychoeducational Course for Suicide Prevention
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
Psychoeducational Course for Suicide Prevention - a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None