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Suicide and Self-harmEVAREST2NCT03325478

Qualitative Assessment of the Brief Contact Intervention "Stay in Contact" in Suicide Prevention

An observational study of Suicide and Self-harm, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: For 40 years, brief contact interventions (BCIs) have been presented as promising approaches in suicide prevention but patient's experiences of BCIs are less investigated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide and Self-harm
What is being tested?
Over the phone interviews on the BCI "Stay in Contact"
How many people
60 participants
Where
1 siteFrance
Study dates
18 May 2017to 31 Aug 2017
Phase
Observational
Are there results?
None posted in the registry

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

Study population: The "Stay in contact" program concerns patients admitted to the PED for suicide attempt and who agree to benefit from this BCI

Who may be able to join

  • be male or female, be aged 18 or older, have a situation permitting follow-up contacts by phone.

Who cannot join

  • be placed under supervision by the law such as guardianship and curatorship, be incarcerated and refusing to participate to the BCI

Trial locations and contacts

1 site in 1 country.

France1 site

  • Central Hospital

    Nancy, Lorraine, 54100

Other trials in France

About this study

Official title: Qualitative Assessment of the French Brief Contact Intervention "Stay in Contact" in Suicide Prevention

Background: For 40 years, brief contact interventions (BCIs) have been presented as promising approaches in suicide prevention but patient's experiences of BCIs are less investigated.

Aim: Understand mechanisms of BCIs after suicide attempt, through patient's experience of a French BCI "Stay in contact" and assess its impact on seeking care during suicidal crisis.

Read more

Method:This is a single-center, non-interventional, prospective qualitative study using phone call interview on a BCI, 6 months after suicide attempt behavior.

Statistical analysis

Data were analyzed using statistical software (Version 9.4, SAS Institute Inc., Cary, North Carolina, USA). Chi-squared test was used to assess qualitative variables and t-test to evaluate quantitative variables, with p<.05 considered significant.

Read the detailed description

The baseline interviews were conducted on the phone, on weekdays, during a mean time of 10 to 15minutes by a trained resident in psychiatry as the only interviewer. The interviewer didn't participate in patient's medical care nor in the follow-up interventions. The interviewer didn't look in patients file before conducted over the phone interviews and had only administrative information on the study subjects: first and last name, age, sex, phone number. The phone call interview wasn't considered as an intervention. Whenever the interviewer judged necessary that a patient needed more intensive treatment, the relevant referral to help was done.

Being tested
Over the phone interviews on the BCI "Stay in Contact"
Medical subject headings
Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Over the phone interviews on the BCI "Stay in Contact"Other

    This study used phone call interviews on a BCI "Stay in Contact", 6 months after suicide attempt behavior.The questionnaire used for the interview of included suicide attempters was pilot tested to assess acceptability and feasibility of the study. It included 24 questions, which were based on literature's data.They covered seeking care and help items and assess the subjective quality appreciation of medical care in the PED and on the BCI.Closed-ended and multiple-choice questions were mixed. Included patients were informed that the questionnaire was anonymous and that seeking their views and feedbacks would help adjusting the implementation of follow-up interventions closer to their needs.The baseline interviews were conducted on the phone, on weekdays, during a mean time of 10 to 15minutes by a trained resident in psychiatry as the only interviewer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. outpatients' experiences of the BCI "Stay in contact"

    to assess the outpatients' experiences of the BCI "Stay in contact" using an hetero questionnaire completed over the phone by patients who benefited from the BCI.

    Measured: At the closure of the BCI Stay in contact, an average of 6 months after suicide attempt

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2017
  2. Study start18 May 2017
  3. Primary completion31 Aug 2017
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03325478
Sponsor's protocol ID
2017-A01023-50
Acronym
EVAREST2
Status last verified
Aug 2017
First submitted
20 Oct 2017
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cedereke M, Monti K, Ojehagen A. Telephone contact with patients in the year after a suicide attempt: does it affect treatment attendance and outcome? A randomised controlled study. Eur Psychiatry. 2002 Apr;17(2):82-91. doi: 10.1016/s0924-9338(02)00632-6.

    PubMed 11973116

  • Hawton K, van Heeringen K. Suicide. Lancet. 2009 Apr 18;373(9672):1372-81. doi: 10.1016/S0140-6736(09)60372-X.

    PubMed 19376453

  • Hawton K, Saunders K, Topiwala A, Haw C. Psychiatric disorders in patients presenting to hospital following self-harm: a systematic review. J Affect Disord. 2013 Dec;151(3):821-30. doi: 10.1016/j.jad.2013.08.020. Epub 2013 Sep 7.

    PubMed 24091302

  • Gruat G, Cottencin O, Ducrocq F, Duhem S, Vaiva G. [Patient satisfaction regarding further telephone contact following attempted suicide]. Encephale. 2010 Jun;36 Suppl 2:D7-D13. doi: 10.1016/j.encep.2009.10.009. Epub 2009 Dec 1. French.

    PubMed 20513463

  • Milner A, Spittal MJ, Kapur N, Witt K, Pirkis J, Carter G. Mechanisms of brief contact interventions in clinical populations: a systematic review. BMC Psychiatry. 2016 Jun 8;16:194. doi: 10.1186/s12888-016-0896-4.

    PubMed 27277833

  • Castaigne E, Hardy P, Mouaffak F. [Follow-up interventions after suicide attempt. What tools, what effects and how to assess them?]. Encephale. 2017 Feb;43(1):75-80. doi: 10.1016/j.encep.2016.08.004. Epub 2016 Sep 28. French.

    PubMed 27692348

  • Kapur N, Cooper J, Bennewith O, Gunnell D, Hawton K. Postcards, green cards and telephone calls: therapeutic contact with individuals following self-harm. Br J Psychiatry. 2010 Jul;197(1):5-7. doi: 10.1192/bjp.bp.109.072496.

    PubMed 20592425

  • Pirkis J, Burgess P, Meadows G, Dunt D. Self-reported needs for care among persons who have suicidal ideation or who have attempted suicide. Psychiatr Serv. 2001 Mar;52(3):381-3. doi: 10.1176/appi.ps.52.3.381.

    PubMed 11239110

  • Burgess P, Pirkis J, Morton J, Croke E. Lessons from a comprehensive clinical audit of users of psychiatric services who committed suicide. Psychiatr Serv. 2000 Dec;51(12):1555-60. doi: 10.1176/appi.ps.51.12.1555.

    PubMed 11097653

  • Appleby L, Shaw J, Amos T, McDonnell R, Harris C, McCann K, Kiernan K, Davies S, Bickley H, Parsons R. Suicide within 12 months of contact with mental health services: national clinical survey. BMJ. 1999 May 8;318(7193):1235-9. doi: 10.1136/bmj.318.7193.1235.

    PubMed 10231250

  • Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.

    PubMed 11376235

  • Foster T, Gillespie K, McClelland R. Mental disorders and suicide in Northern Ireland. Br J Psychiatry. 1997 May;170:447-52. doi: 10.1192/bjp.170.5.447.

    PubMed 9307695

  • Hawton K et al. Attempted suicide : a practical Guide to its nature and management, 2nd ed. Oxford: Oxford University Press; 1987

  • Kerkhof A al. Repetition of attempted suicide: results from the WHO/EU Multicentre Study on Parasuicide, repetition-prediction part. 7th European Symposium on Suicide and Suicidal Behaviour. Ghent: University Press; 1998

  • Rygnestad T. [A 15-year follow-up study after deliberate self-poisoning]. Tidsskr Nor Laegeforen. 1997 Sep 10;117(21):3065-9. Norwegian.

    PubMed 9381437

Questions about this trial

What is this clinical trial studying?

An observational study of Suicide and Self-harm, run by Central Hospital, Nancy, France at 1 site in France.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

outpatients' experiences of the BCI "Stay in contact" (time frame: At the closure of the BCI Stay in contact, an average of 6 months after suicide attempt). 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 NCT03325478, which also lists 24 linked publications.

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 30 Oct 2017.

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