A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP
- Conditions
- Suicide, Attempted
- Interventions
- Behavioral: ASSIP + treatment as usualOther: Treatment as usual and patient safety
- Registration Number
- NCT04746261
- Lead Sponsor
- Region Skane
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASSIP plus treatment as usual ASSIP + treatment as usual ASSIP according to manual. Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required. Treatment as usual Treatment as usual and patient safety Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required. ASSIP plus treatment as usual Treatment as usual and patient safety ASSIP according to manual. Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required.
- Primary Outcome Measures
Name Time Method Number of suicide attempts up to 3 months after inclusion 3 months after inclusion in study Telephone follow up at 3 months after inclusion. Medical records data. Register data.
Incremental Cost-Effectiveness Ratio( ICER). 24 months after inclusion RCT outcomes put into perspective using a health-economic model with a life-time horizon, evidence from literature and complementary register data.
Number of suicide attempts up to 24 months after inclusion 24 months after inclusion in study Repeated telephone follow up at 3, 12 and 24 months after inclusion. Medical records data. Register data
Number of suicide attempts up to 12 months after inclusion 12 months after inclusion in study Repeated telephone follow up at 3, 12 after inclusion. Medical records data. Register data.
- Secondary Outcome Measures
Name Time Method Changes in Quality of life 24 months Self reported quality of life reported according to the EuroQol Research Foundation, EQ-5D-5L at 24 months follow up in comparison with first visit.The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: Each dimension has 5 levels: A higher 1-digit number mean a worse outcome. High scores on the EQ VAS mean a better outcome.
Number of suicidal thoughts/plans within 3 months after inclusion 3 months after inclusion in study Repeated self ratings, suicidal thoughts defined as MADRS-S (Montgomery-Asberg Depression Rating Scale) question 9 score above or equal to 4 at 3 months
Periods of employment, unemployment, education, military service or pension 24 months Periods of employment, unemployment, education, military service or pension registered in the Longitudinal integrated database for health insurance and labour market studies (LISA)
Number of days with sickness and disability benefits 24 months Number of days with sickness or disability benefits registered according to the Swedish Social Insurance Agency
Health care contacts and treatments 24 months after inclusion Number and type of healthcare contacts according to telephone interviews and medical records
Number of suicidal thoughts/plans within 24 months after inclusion 24 months after inclusion in study Repeated self ratings, suicidal thoughts defined as MADRS-S (Montgomery-Asberg Depression Rating Scale) question 9 score above or equal to 4 at 3, 12 and 24 months
Number of suicidal thoughts/plans within 12 months after inclusion 12 months after inclusion in study Repeated self ratings, suicidal thoughts defined as MADRS-S (Montgomery-Asberg Depression Rating Scale) question 9 score above or equal to 4 at 3 and 12 months
Amount of income from employment, social insurance, student aid, pension and unemployment benefits. 24 months Amount of income from employment, social insurance, student aid, pension and unemployment benefits registered in the Longitudinal integrated database for health insurance and labour market studies (LISA)
Trial Locations
- Locations (2)
Region Skåne, psykiatri & habilitering, psykiatriforskning skane, Vuxenpsykiatri Lud
🇸🇪Lund, Sweden
Region Skåne, psykiatri & habilitering, psykiatriforskning skane,Vuxenpsykiatri Malmoe
🇸🇪Malmö, Sweden