Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746261
Status:
RECRUITING
Last Update Posted:
2023-01-05
First Post:
2020-08-12
Brief Title:
A Randomized Clinical Study of Attempted Suicide Short Intervention Program in Swedish Healthcare - ASSIP
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
A Randomized Clinical Study of Attempted Suicide Short Intervention Program in Swedish Healthcare - ASSIP
Status:
RECRUITING
Status Verified Date:
2023-01
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:
This is a randomized study of ASSIP as a treatment for patients who have recently made a suicide attempt Six psychiatric clinics from four regions in Sweden are included Together 460 patients will be recruited Patients will be randomized to ASSIP as a supplement to treatment as usual or to treatment as usual only
The overall aim of the study is to evaluate whether ASSIP a short-term clinical intervention can prevent future suicidal behavior in people who have attempted suicide better than just conventional treatment The project also investigates whether there are any specific factors that may be related to ASSIPs potential effectiveness and whether ASSIP has health economic benefits
Only patients who give their written consent will be included in the study Those who meet the inclusion and no exclusion criteria at screening visit 1 undergo an assessment according to an interview protocol self-assessment form and self-assessment scales Thereafter the patient is randomized via an electronic system to either ASSIP plus standard treatment or only standard treatment All patients regardless of which treatment they are randomized to will be followed up for two years with a telephone interview and self-assessment scales month 3 12 and 24 Data from medical records and registers will also be collected
The overall aim of the study is to evaluate whether ASSIP a short-term clinical intervention can prevent future suicidal behavior in people who have attempted suicide better than just conventional treatment The project also investigates whether there are any specific factors that may be related to ASSIPs potential effectiveness and whether ASSIP has health economic benefits
Only patients who give their written consent will be included in the study Those who meet the inclusion and no exclusion criteria at screening visit 1 undergo an assessment according to an interview protocol self-assessment form and self-assessment scales Thereafter the patient is randomized via an electronic system to either ASSIP plus standard treatment or only standard treatment All patients regardless of which treatment they are randomized to will be followed up for two years with a telephone interview and self-assessment scales month 3 12 and 24 Data from medical records and registers will also be collected
Detailed Description:
Purpose and aims
The overall purpose of this project is to evaluate ASSIP for the prevention of future suicidal behavior in persons who attempt suicide The specific goals are a to examine the effectiveness of Attempted Suicide Short Intervention Program ASSIP in reducing new suicide attempts in Swedish healthcare b to identify factors associated with the effectiveness of ASSIP c to construct a cost-effectiveness model of ASSIP
Background
According to a consensus position paper from the evidence-based national suicide prevention task force in Europe health care approaches with high evidence include treatment of depression and ensuring chain of care These strategies are in line with Swedish guidelines However several recent international studies suggest that interventions specifically targeted to prevent suicide attempts may be more successful and that brief psychological interventions are of interest One promising brief psychotherapeutic intervention to prevent new suicide attempts in suicide attempters is ASSIP An RCT from Switzerland that included 120 patients showed an 80 risk reduction for new suicide attempt within two years when ASSIP was added on to treatment as usual TAU compared to TAU alone
Study design
This is an evaluator-blinded multicenter randomized controlled trial RCT The patients will be examined with a structured interview and self-rating scales at baseline first visit and structured telephone interviews self-rating scales and medical record screening at 3 months 12 months and 24 months follow up Completed suicides will be detected through the Cause of Death Register The study will also collect information from the National Board of Health and Welfare NBHW National Prescribed Drugs Register NPDR Longitudinal integrated database for health insurance and labour market studies LISA and the Swedish Social Insurance Agency Försäkringskassan
Randomization After the first visit the patients will be randomized to ASSIP TAU or TAU only using stratified randomization according to clinical site The randomization will be performed through REDCAP a web-based application for electronic data collection in research studies Expected site differences To map the variation of TAU with site age gender ICD diagnoses and previous suicide attempts health care contacts and treatments a TAU check list will be used
The overall purpose of this project is to evaluate ASSIP for the prevention of future suicidal behavior in persons who attempt suicide The specific goals are a to examine the effectiveness of Attempted Suicide Short Intervention Program ASSIP in reducing new suicide attempts in Swedish healthcare b to identify factors associated with the effectiveness of ASSIP c to construct a cost-effectiveness model of ASSIP
Background
According to a consensus position paper from the evidence-based national suicide prevention task force in Europe health care approaches with high evidence include treatment of depression and ensuring chain of care These strategies are in line with Swedish guidelines However several recent international studies suggest that interventions specifically targeted to prevent suicide attempts may be more successful and that brief psychological interventions are of interest One promising brief psychotherapeutic intervention to prevent new suicide attempts in suicide attempters is ASSIP An RCT from Switzerland that included 120 patients showed an 80 risk reduction for new suicide attempt within two years when ASSIP was added on to treatment as usual TAU compared to TAU alone
Study design
This is an evaluator-blinded multicenter randomized controlled trial RCT The patients will be examined with a structured interview and self-rating scales at baseline first visit and structured telephone interviews self-rating scales and medical record screening at 3 months 12 months and 24 months follow up Completed suicides will be detected through the Cause of Death Register The study will also collect information from the National Board of Health and Welfare NBHW National Prescribed Drugs Register NPDR Longitudinal integrated database for health insurance and labour market studies LISA and the Swedish Social Insurance Agency Försäkringskassan
Randomization After the first visit the patients will be randomized to ASSIP TAU or TAU only using stratified randomization according to clinical site The randomization will be performed through REDCAP a web-based application for electronic data collection in research studies Expected site differences To map the variation of TAU with site age gender ICD diagnoses and previous suicide attempts health care contacts and treatments a TAU check list will be used
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