RecruitingNot ApplicableNCT04746261

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

Sponsor

Region Skane

Enrollment

460 participants

Start Date

Oct 15, 2020

Study Type

INTERVENTIONAL

Conditions

Suicide, Attempted

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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.

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Interventions

BEHAVIORALASSIP + treatment as usual

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

OTHERTreatment as usual and patient safety

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.