NCT03983356

Brief Summary

The purpose of this project is to improve the management of suicide and common mental disorder by general practitioners (GPs) in Bulgaria in order to reduce the suicide rate in intervention regions. The study uses a natural experiment design which utilizes a training program aimed at improving the GPs management of suicide risk and detection of common mental disorders. The training program will be offered to four regions (North East, South West, South Central, South East), leaving two regions for control (North Central, North West), in order to evaluate the effect of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

August 30, 2016

Last Update Submit

June 11, 2019

Conditions

Suicide

Keywords

General PractitionerTraining Program

Outcome Measures

Primary Outcomes (1)

  • Change in regional suicide rate

    Number of suicides per 100 000

    Before and after intervention. Before intervention is from January 2012 to December 2015. After intervention is defined as post July 2016 with follow-up data to December 2017.

Secondary Outcomes (1)

  • Change in regional suicide attempt rate

    Before intervention is from January 2012 to December 2015. After intervention is defined as post July 2016 with follow-up data to December 2017.

Study Arms (2)

Group of GPs receiving training

EXPERIMENTAL

GPs, psychologists and social workers in the intervention regions will receive a training program.

Other: Training program

Group of GPs receiving no attention

NO INTERVENTION

GPs, psychologists and social workers in the control regions will not receive information about the intervention.

Interventions

Training programOTHER

An internet based training program will be offered to GPs. We will also offer face-to-face seminars with academic psychiatrists.

Group of GPs receiving training

Eligibility Criteria

Age24 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GP, psychologist, social worker in Bulgaria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Centre of Public Health and Analyses (NCPHA)

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Related Publications (18)

  • WHO. Suicide rates. Data by country [http://apps.who.int/gho/data/node.main.MHSUICIDE?lang=en]. 2015.

    BACKGROUND

  • Luoma JB, Martin CE, Pearson JL. Contact with mental health and primary care providers before suicide: a review of the evidence. Am J Psychiatry. 2002 Jun;159(6):909-16. doi: 10.1176/appi.ajp.159.6.909.

    PMID: 12042175BACKGROUND

  • Pfaff JJ, Acres JG, McKelvey RS. Training general practitioners to recognise and respond to psychological distress and suicidal ideation in young people. Med J Aust. 2001 Mar 5;174(5):222-6. doi: 10.5694/j.1326-5377.2001.tb143241.x.

    PMID: 11280692BACKGROUND

  • Rutz W, von Knorring L, Walinder J. Long-term effects of an educational program for general practitioners given by the Swedish Committee for the Prevention and Treatment of Depression. Acta Psychiatr Scand. 1992 Jan;85(1):83-8. doi: 10.1111/j.1600-0447.1992.tb01448.x.

    PMID: 1546555BACKGROUND

  • Mann JJ, Apter A, Bertolote J, Beautrais A, Currier D, Haas A, Hegerl U, Lonnqvist J, Malone K, Marusic A, Mehlum L, Patton G, Phillips M, Rutz W, Rihmer Z, Schmidtke A, Shaffer D, Silverman M, Takahashi Y, Varnik A, Wasserman D, Yip P, Hendin H. Suicide prevention strategies: a systematic review. JAMA. 2005 Oct 26;294(16):2064-74. doi: 10.1001/jama.294.16.2064.

    PMID: 16249421BACKGROUND

  • Szanto K, Kalmar S, Hendin H, Rihmer Z, Mann JJ. A suicide prevention program in a region with a very high suicide rate. Arch Gen Psychiatry. 2007 Aug;64(8):914-20. doi: 10.1001/archpsyc.64.8.914.

    PMID: 17679636BACKGROUND

  • Nock MK, Borges G, Bromet EJ, Cha CB, Kessler RC, Lee S. Suicide and suicidal behavior. Epidemiol Rev. 2008;30(1):133-54. doi: 10.1093/epirev/mxn002. Epub 2008 Jul 24.

    PMID: 18653727BACKGROUND

  • WHO: Preventing Suicide: A global imperative. 2014.

    BACKGROUND

  • Hegerl U, Althaus D, Schmidtke A, Niklewski G. The alliance against depression: 2-year evaluation of a community-based intervention to reduce suicidality. Psychol Med. 2006 Sep;36(9):1225-33. doi: 10.1017/S003329170600780X. Epub 2006 May 17.

    PMID: 16707028BACKGROUND

  • Szekely A, Konkoly Thege B, Mergl R, Birkas E, Rozsa S, Purebl G, Hegerl U. How to decrease suicide rates in both genders? An effectiveness study of a community-based intervention (EAAD). PLoS One. 2013 Sep 23;8(9):e75081. doi: 10.1371/journal.pone.0075081. eCollection 2013.

    PMID: 24086443BACKGROUND

  • Robinson J, Hetrick SE, Martin C. Preventing suicide in young people: systematic review. Aust N Z J Psychiatry. 2011 Jan;45(1):3-26. doi: 10.3109/00048674.2010.511147.

    PMID: 21174502BACKGROUND

  • du Roscoat E, Beck F. Efficient interventions on suicide prevention: a literature review. Rev Epidemiol Sante Publique. 2013 Aug;61(4):363-74. doi: 10.1016/j.respe.2013.01.099. Epub 2013 Jul 10.

    PMID: 23849295BACKGROUND

  • WHO. Suicide rates, age-standardized. Data by country [https://web.archive.org/web/20180117045516/http://apps.who.int/gho/data/node.main.MHSUICIDEASDR?lang=en]. 2015.

    BACKGROUND

  • Prince M: Does Active Learning Work? A Review of the Research. Journal of Engineering Education 2004, 93(3):223-231.

    BACKGROUND

  • Michael J. Where's the evidence that active learning works? Adv Physiol Educ. 2006 Dec;30(4):159-67. doi: 10.1152/advan.00053.2006.

    PMID: 17108243BACKGROUND

  • Shellman SM, Turan K: Do Simulations Enhance Student Learning? An Empirical Evaluation of an IR Simulation. Journal of Political Science Education 2006, 2(1):19-32.

    BACKGROUND

  • Fenwick CD, Vassilas CA, Carter H, Haque MS. Training health professionals in the recognition, assessement and management of suicide risk. Int J Psychiatry Clin Pract. 2004;8(2):117-21. doi: 10.1080/13651500410005658.

    PMID: 24926844BACKGROUND

  • Haidet P, Morgan RO, O'Malley K, Moran BJ, Richards BF. A controlled trial of active versus passive learning strategies in a large group setting. Adv Health Sci Educ Theory Pract. 2004;9(1):15-27. doi: 10.1023/B:AHSE.0000012213.62043.45.

    PMID: 14739758BACKGROUND

Related Links

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Hristo Hinkov, MD, PhD

    National Center of Public Health and Analyses

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2016

First Posted

June 12, 2019

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

March 1, 2018

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)