Clinical trial NCT04746261: A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP
Official title: A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ASSIP's 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Signed informed consent to participate in the study.
* Contact with psychiatric health care after a suicide attempt within 3 months before the baseline visit
* Booked meeting or visit in psychiatry or primary care after visit 1

Exclusion Criteria:

* Psychotic illness with current delusions, hallucinations or other negative symptoms that may affect the therapy.
* Known emotionally unstable personality disorder (ICD 10) noted in the medical record
* Inability to undergo therapy without an interpreter
* Mental retardation, dementia, or other circumstances that make it difficult to understand the meaning of participating in the study and giving informed consent.

Primary outcomes:
measure: Number of suicide attempts up to 24 months after inclusion
timeFrame: 24 months after inclusion in study
measure: Number of suicide attempts up to 12 months after inclusion
timeFrame: 12 months after inclusion in study
measure: Number of suicide attempts up to 3 months after inclusion
timeFrame: 3 months after inclusion in study
measure: Incremental Cost-Effectiveness Ratio( ICER).
timeFrame: 24 months after inclusion
Secondary outcomes:
measure: Number of suicidal thoughts/plans within 24 months after inclusion
timeFrame: 24 months after inclusion in study
measure: Number of suicidal thoughts/plans within 12 months after inclusion
timeFrame: 12 months after inclusion in study
measure: Number of suicidal thoughts/plans within 3 months after inclusion
timeFrame: 3 months after inclusion in study
measure: Health care contacts and treatments
timeFrame: 24 months after inclusion
measure: Changes in Quality of life
timeFrame: 3 months
measure: Changes in Quality of life
timeFrame: 12 months
measure: Changes in Quality of life
timeFrame: 24 months
measure: Periods of employment, unemployment, education, military service or pension
timeFrame: 24 months
measure: Amount of income from employment, social insurance, student aid, pension and unemployment benefits.
timeFrame: 24 months
measure: Number of days with sickness and disability benefits
timeFrame: 24 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Region Skåne, psykiatri & habilitering, psykiatriforskning skane, Vuxenpsykiatri Lud
city: Malmö
country: Sweden
facility: Region Skåne, psykiatri & habilitering, psykiatriforskning skane,Vuxenpsykiatri Malmoe
Study officials:
affiliation: Region Skane
name: Åsa Westrin, professor
role: PRINCIPAL_INVESTIGATOR
References: