A Psycho-educational Intervention for People With Suicidal in Prisons

NCT05195554 | Unknown DMC

• 1 other identifier: 2021059
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed as a multicentric, randomized, two parallel-group, controlled trial. The study population will be male and female inmates of nine prisons of Catalonia (Spain). The primary outcome will be the total number of suicidal behaviours for 12 months of follow-up. This project aims to assess the effectiveness of a psycho-educational intervention on reducing the number of suicidal behaviours in the prison environment. If positive, the prison community will have a new tool to curb suicide in prisons.

Conditions

Suicide

Keywords

suicide; suicide behaviour; suicide prevention; prison environment; psychoeducational intervention; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Total number of suicidal behaviours

  The primary outcome will be the total number of suicidal behaviours -which includes both suicide attempts and suicides- registered during the first year after being included in the study.

  12 months

Secondary Outcomes (5)

• Suicide risk

  12 months

• Severity of suicidal ideation

  12 months

• Depression

  12 months

• Anxiety

  12 months

• Quality of life (QOL)

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention groups will involve a psycho-educational intervention and will consist of between 10 and 12 people led by two professionals, one of whom must be a psychologist, while the other may be any professional in the center (usually social workers).

Other: Psycho-educational intervention

Control group

NO INTERVENTION

Participants in the control group will receive information on suicide and advice if the suicidal ideation increases.

Interventions

Psycho-educational intervention OTHER

Psycho-educational intervention will consist of between 10 and 12 people led by two professionals.

Intervention group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants who have presented some kind of suicidal or high-risk behavior in the criterion of self-directed violence according to the RisCanvi\*.

You may not qualify if:

• Decompensation of severe mental disorder
• Intellectual disability
• Cognitive impairment.
• Isolation
• RisCanvi is an instrument used by penitentiary professionals, based on the individualized and structured assessment of a set of pre-established variables, in order to manage the probabilities of increased and decreased risk of prison inmates for further episodes of violent behavior. The full RisCanvi scale consists of 43 risk factors grouped in the following areas: criminological, personal and biographical, social, family, clinical, and personality. These 43 factors are added to the assessment of the future risk of the emergence of four behaviors: self-directed violence, intra-institutional violence, repeat violence, and prison-breaking).

Sponsors & Collaborators

• Consorci Hospitalari de Vic: lead
• Government of Catalonia: collaborator

Study Sites (1)

Vic University Hospital

Vic, Catalonia, 08500, Spain

Location

Related Publications (14)

• Suicide worldwide in 2019: global health estimates. Geneva: World Health Organization; 2021. Available at: https://www.who.int/teams/mental-health-and-substance-use/data-research/suicide-data. Accessed 10 December 2021.

  BACKGROUND

• Ministerio del Interior. Mortalidad en Instituciones Penitenciària s (II.PP.) Año 2017. Boletín epidemiológico de Instituciones Penitenciària. 2019; 24 (2).

  BACKGROUND

• Department of Justice. Penitentiary services. Statistics data 2018. Available at: http://justicia.gencat.cat/ca/departament/Estadistiques/serveis_penitenciaris. Accessed 10 December 2021.

  BACKGROUND

• World Health Organization. Preventing suicide in jails and prisons. Geneve: WHO; 2007.

  BACKGROUND

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Ferrando L, Bobes J, Gibert M, Soto M, Soto O. M.I.N.I. Mini International Neuropsychiatric Interview. Versión en español 5.0.0.DSM-IV. Instituto IAP, Madrid, 1998

  BACKGROUND

• Zhong S, Senior M, Yu R, Perry A, Hawton K, Shaw J, Fazel S. Risk factors for suicide in prisons: a systematic review and meta-analysis. Lancet Public Health. 2021 Mar;6(3):e164-e174. doi: 10.1016/S2468-2667(20)30233-4. Epub 2021 Feb 10.

  PMID: 33577780 RESULT

• Cramer RJ, Wechsler HJ, Miller SL, Yenne E. Suicide Prevention in Correctional Settings: Current Standards and Recommendations for Research, Prevention, and Training. J Correct Health Care. 2017 Jul;23(3):313-328. doi: 10.1177/1078345817716162. Epub 2017 Jun 28.

  PMID: 28656789 RESULT

• Pratt D, Tarrier N, Dunn G, Awenat Y, Shaw J, Ulph F, Gooding P. Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial. Psychol Med. 2015 Dec;45(16):3441-51. doi: 10.1017/S0033291715001348. Epub 2015 Jul 13.

  PMID: 26165919 RESULT

• Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989 Mar;27(3 Suppl):S178-89. doi: 10.1097/00005650-198903001-00015.

  PMID: 2646488 RESULT

• Leidenfrost CM, Schoelerman RM, Maher M, Antonius D. The development and efficacy of a group intervention program for individuals with serious mental illness in jail. Int J Law Psychiatry. 2017 Sep-Oct;54:98-106. doi: 10.1016/j.ijlp.2017.06.004. Epub 2017 Jun 24.

  PMID: 28655427 RESULT

• Winicov N. A systematic review of behavioral health interventions for suicidal and self-harming individuals in prisons and jails. Heliyon. 2019 Sep 6;5(9):e02379. doi: 10.1016/j.heliyon.2019.e02379. eCollection 2019 Sep.

  PMID: 31517115 RESULT

• Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.

  PMID: 30714749 RESULT

• Eck M, Scouflaire T, Debien C, Amad A, Sannier O, Chan Chee C, Thomas P, Vaiva G, Fovet T. [Suicide in prison: Epidemiology and prevention]. Presse Med. 2019 Jan;48(1 Pt 1):46-54. doi: 10.1016/j.lpm.2018.11.009. Epub 2019 Jan 23. French.

  PMID: 30685227 RESULT

MeSH Terms

Conditions

Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Quintí Foguet-Boreu, MD,PhD

  Consorci Hospitalari de Vic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quintí Foguet-Boreu, MD,PhD

CONTACT

+34938891111; 42292qfb@comb.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind assessment of the response variables.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of epidemiology

Model Details: The study design is a multicentric, randomized, controlled trial with two parallel groups, with blind assessment of the response variables, with a 12-months of follow-up.

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 19, 2022
• Study Start: January 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)