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

NCT04746261 | Recruiting

• 1 other identifier: 2020-02360
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 2

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.

Conditions

Suicide, Attempted

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Number of suicidal thoughts/plans within 24 months after inclusion

  24 months after inclusion in study

• Number of suicidal thoughts/plans within 12 months after inclusion

  12 months after inclusion in study

• Number of suicidal thoughts/plans within 3 months after inclusion

  3 months after inclusion in study

• Health care contacts and treatments

  24 months after inclusion

• Changes in Quality of life

  3 months

Study Arms (2)

ASSIP plus treatment as usual

EXPERIMENTAL

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; Other: Treatment as usual and patient safety

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

ASSIP + treatment as usual BEHAVIORAL

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

ASSIP plus treatment as usual

Treatment as usual and patient safety OTHER

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.

ASSIP plus treatment as usual; Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Region Skåne, psykiatri & habilitering, psykiatriforskning skane, Vuxenpsykiatri Lud

Lund, Sweden

RECRUITING

Region Skåne, psykiatri & habilitering, psykiatriforskning skane,Vuxenpsykiatri Malmoe

Malmo, Sweden

NOT YET RECRUITING

Related Publications (1)

• Lindstrom S, Ehnvall A, Bergqvist E, Waern M, Dahlin M, Westrin A. A study protocol of the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP) for recent suicide attempters: a randomized controlled trial. BMC Psychiatry. 2024 Oct 4;24(1):655. doi: 10.1186/s12888-024-06109-z.

  PMID: 39367366 DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Therapeutics; Patient Safety

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Safety; Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Åsa Westrin, professor

  Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Åsa Westrin, MD, PhD

CONTACT

+4670 624 38 87; asa.westrin@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: February 9, 2021
• Study Start: October 15, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

SE (2)