Suicide, AttemptedNCT04746261
A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP
A study testing ASSIP + treatment as usual and Treatment as usual and patient safety in people with Suicide, Attempted, run by Region Skane at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- ASSIP + treatment as usual and Treatment as usual and patient safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Oct 2020to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Region Skåne, psykiatri & habilitering, psykiatriforskning skane, Vuxenpsykiatri Lud
Lund
Åsa Westrin, MD, PhD, +4670 624 38 87, asa.westrin@med.lu.se
- Not yet recruiting
Region Skåne, psykiatri & habilitering, psykiatriforskning skane,Vuxenpsykiatri Malmoe
Malmö
Åsa Westrin, MD, PhD, +4670 624 38 87, asa.westrin@med.lu.se
Joanna Månsson, RN
About this study
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.
Read the 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.
- Conditions
- Suicide, Attempted
- Being tested
- ASSIP + treatment as usual, Treatment as usual and patient safety
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSIP + treatment as usualBehavioural
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
Treatment as usual and patient safetyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual and patient safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months after inclusion
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 3 months after inclusion in study
Health care contacts and treatments
Number and type of healthcare contacts according to telephone interviews and medical records
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start15 Oct 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Åsa Westrin, professor, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746261
- Sponsor's protocol ID
- 2020-02360
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2020
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39367366
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP
- ClinicalTrials.gov ID
- NCT04746261
- Acronym / sponsor ID
- 2020-02360
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASSIP plus treatment as usual | Experimental | Behavioral: ASSIP + treatment as usual, Other: Treatment as usual and patient safetyASSIP 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 | Active comparator | Other: Treatment as usual and patient safetyTreatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASSIP + treatment as usualASSIP: 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 | Behavioural | ASSIP plus treatment as usual |
| Treatment as usual and patient safetyAll 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. | Other | ASSIP plus treatment as usual, Treatment as usual |
Primary outcome
Number of suicide attempts up to 24 months after inclusion
Time frame: 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
Time frame: 12 months after inclusion in study
Repeated telephone follow up at 3, 12 after inclusion. Medical records data. Register data.
Number of suicide attempts up to 3 months after inclusion
Time frame: 3 months after inclusion in study
Telephone follow up at 3 months after inclusion. Medical records data. Register data.
Incremental Cost-Effectiveness Ratio( ICER).
Time frame: 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.
10 secondary outcomes
Number of suicidal thoughts/plans within 24 months after inclusion
Time frame: 24 months after inclusion in study
Number of suicidal thoughts/plans within 12 months after inclusion
Time frame: 12 months after inclusion in study
Number of suicidal thoughts/plans within 3 months after inclusion
Time frame: 3 months after inclusion in study
Health care contacts and treatments
Time frame: 24 months after inclusion
Changes in Quality of life
Time frame: 3 months
Changes in Quality of life
Time frame: 12 months
Changes in Quality of life
Time frame: 24 months
Periods of employment, unemployment, education, military service or pension
Time frame: 24 months
Amount of income from employment, social insurance, student aid, pension and unemployment benefits.
Time frame: 24 months
Number of days with sickness and disability benefits
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Derived from this study: PubMed 39367366Lindstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Åsa Westrin, professor principal investigator
Region Skane
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIP + treatment as usual and Treatment as usual and patient safety in people with Suicide, Attempted, run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Åsa Westrin, MD, PhD (+4670 624 38 87, asa.westrin@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of suicide attempts up to 24 months after inclusion (time frame: 24 months after inclusion in study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.