A Randomized Clinical Study of Attempted Suicide Short Intervention Program in Swedish Healthcare - ASSIP

Study Overview
=================
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.

Official Title
-----------------
A Randomized Clinical Study of Attempted Suicide Short Intervention Program in Swedish Healthcare - ASSIP

Conditions
-----------------
Suicide, Attempted

Intervention / Treatment
-----------------
* Behavioral: ASSIP + treatment as usual
* Other: Treatment as usual and patient safety


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASSIP plus treatment as usual<br>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. | Behavioral: ASSIP + treatment as usual<br>* ASSIP: First session: Videotaped narrative interview focusing on the background to the suicidal crisis. Second session: Video playback. The patient and the therapist watch the recorded interview together, stopping the film regularly to add information. The patient is given a psychoeducational text to read and comment on as homework. Third session: Compilation of a written case formulation of the individual's vulnerability and triggering events that preceded the suicidal crisis. Individual preventive measures are developed by the patient and the therapist together and written down in a document that the patient keeps and which is attached to the patient's medical record. Fourth session (optional): Mini-exposure. Standardized letters: The therapist contacts the patient by letter during two years, every three months the first year and every six months the second year. Treatment as usual: As described bellow<br>Other: Treatment as usual and patient safety<br>* All patients follow their usual care, regardless of whether they are treated with ASSIP or not. Usual care is multidisciplinary and combines psychotherapy, pharmacotherapy and other treatments, including referral to specialist psychiatric units or primary care. This depends on the assessments made by the patient's usual care provider. Treatment as usual is monitored by the research team through a standardised medical record review. In order to increase patient safety, some standardisation of usual care takes place. The research nurse communicates with the referring healthcare provider to ensure that the patient receives a follow-up appointment within the usual care setting after the initial visit and the research team informs the usual care provider and acts when acute suicide risk is detected. In most sites, some information from SIS, CSSR-S and MINI assessments is noted in the patient's medical records.<br>|
| Active Comparator: Treatment as usual<br>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. | Other: Treatment as usual and patient safety<br>* All patients follow their usual care, regardless of whether they are treated with ASSIP or not. Usual care is multidisciplinary and combines psychotherapy, pharmacotherapy and other treatments, including referral to specialist psychiatric units or primary care. This depends on the assessments made by the patient's usual care provider. Treatment as usual is monitored by the research team through a standardised medical record review. In order to increase patient safety, some standardisation of usual care takes place. The research nurse communicates with the referring healthcare provider to ensure that the patient receives a follow-up appointment within the usual care setting after the initial visit and the research team informs the usual care provider and acts when acute suicide risk is detected. In most sites, some information from SIS, CSSR-S and MINI assessments is noted in the patient's medical records.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suicide attempts up to 24 months after inclusion | Repeated telephone follow up at 3, 12 and 24 months after inclusion. Medical records data. Register data | 24 months after inclusion in study | 
| Number of suicide attempts up to 12 months after inclusion | Repeated telephone follow up at 3, 12 after inclusion. Medical records data. Register data. | 12 months after inclusion in study | 
| Number of suicide attempts up to 3 months after inclusion | Telephone follow up at 3 months after inclusion. Medical records data. Register data. | 3 months after inclusion in study | 
| Incremental Cost-Effectiveness Ratio( ICER). | RCT outcomes put into perspective using a health-economic model with a life-time horizon, evidence from literature and complementary register data. | 24 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suicidal thoughts/plans within 24 months after inclusion | 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 | 24 months after inclusion in study | 
| Number of suicidal thoughts/plans within 12 months after inclusion | 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 | 12 months after inclusion in study | 
| Number of suicidal thoughts/plans within 3 months after inclusion | 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 | 3 months after inclusion in study | 
| Health care contacts and treatments | Number and type of healthcare contacts according to telephone interviews and medical records | 24 months after inclusion | 
| Changes in Quality of life | Self reported quality of life reported according to the EuroQol Research Foundation, EQ-5D-5L at 3 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. | 3 months | 
| Changes in Quality of life | Self reported quality of life reported according to the EuroQol Research Foundation, EQ-5D-5L at 12 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. | 12 months | 
| Changes in Quality of life | 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. | 24 months | 
| Periods of employment, unemployment, education, military service or pension | Periods of employment, unemployment, education, military service or pension registered in the Longitudinal integrated database for health insurance and labour market studies (LISA) | 24 months | 
| Amount of income from employment, social insurance, student aid, pension and unemployment benefits. | 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) | 24 months | 
| Number of days with sickness and disability benefits | Number of days with sickness or disability benefits registered according to the Swedish Social Insurance Agency | 24 months |