A Psycho-educational Intervention for People With Suicidal in Prisons

Suicide Clinical Trial

— N'VIU  

Official title:

Effectiveness of a Psycho-educational Intervention for People With Suicidal Conduct in the Prison Environment. N'VIU Project: a Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05195554
• Other study ID #: 2021059
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Consorci Hospitalari de Vic
• Contact: Quintí Foguet-Boreu, MD,PhD
• Phone: +34938891111
• Email: 42292qfb[@]comb.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: Suicide rates are higher in the prison environment than in the general population. Prevention involves strategies to promote mental health, early diagnosis, treatment and identification of precipitating factors. The aim of this study is to evaluate the effectiveness of a psychoeducational group intervention performed by rehabilitation professionals to decrease the number of suicidal behaviors in the penitentiary environment.

Methods: 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. Secondary outcomes will be suicide risk evaluated with the International Neuropsychiatric Interview (MINI); the severity of suicidal ideations assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS), the presence of depressive and anxiety symptoms [Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS)] and health-related quality of life (EQ-5D). Other variables will be clinical and socio-demographic. Intervention will consist of 17 psychoeducation sessions for the intervention group and information on suicide for the control group.

Conclusions: 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Suicide

Intervention

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

Locations

Country	Name	City	State
Spain	Vic University Hospital	Vic	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Hospitalari de Vic	Government of Catalonia

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson 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. — View Citation

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 — View Citation

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

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. Review. French. — View Citation

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

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 — View Citation

Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989 Mar;27(3 Suppl):S178-89. — View Citation

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 20 — View Citation

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

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. — View Citation

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.

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. Review. — View Citation

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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Suicide risk	This risk will be evaluated with the International Neuropsychiatric Interview (MINI). The MINI is a structured diagnostic interview, of short duration, with six yes or no questions. It allows for a score between 0 and 35, with 1-5 corresponding to a slight suicide risk, 6-9 moderate and 10 high.	12 months
Secondary	Severity of suicidal ideation	The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess the seriousness of the suicidal ideation. C-SSRS will be used to assess the seriousness of the suicidal ideation, included four constructs: 1) the severity of ideation, with a subscale that evaluates 5 types of increasing gravity (from 1: wish to be dead; to 5: active suicidal ideation with specific plan and intent); 2) intensity of ideation, consisting of 5 elements -frequency, duration, controllability, deterrents, reasons for ideation- each with a subscale from either 0 to 5 or 1 to 5. 3) suicidal behavior, with a subscale that evaluates with a nominal scale actual, interrupted and aborted attempts, preparatory acts and non-suicidal self-destructive conduct; and 4) lethality of the suicide attempt, which evaluates with an ordinal scale of 6 points (from 0: there is no physical damage to 5: death.	12 months
Secondary	Depression	We will evaluate the presence of depressive symptoms with the Hamilton Depression Rating Scale (HDRS). The scale provides a global score of severity of the depression between 0 and 52. The cutting points recommended by the National Institute for Health and Care Excellence (NICE) guide are: 0-7: non-depression; 8-13: light depression; 14-18: moderate depression; 19-22: severe depression, and =23: very severe depression.	12 months
Secondary	Anxiety	To evaluate the presence of anxiety symptoms, we will use the Hamilton Anxiety Rating Scale (HARS), a hetero-administered scale that aims to assess the intensity of anxiety. It consists of 14 items that evaluate the mental, physical and behavioral aspects of anxiety. The time frame is the previous 3 days on all items except the last. It provides a global measure of anxiety obtained by adding the score obtained in each item, with 0-5 indicating non-anxiety; 6-14 mild anxiety; and =15 moderate/severe anxiety. There is a validated Spanish version.	12 months
Secondary	Quality of life (QOL)	This will be measured through the EuroQoL-5D Health Questionary (EQ-5D), a self-applied questionnaire consisting of two parts: the first assesses 5 dimensions: mobility, personal care, everyday activities, pain/disease and anxiety/depression. For each dimension, three states are described: absence of problems (1 point), moderate problems (2 points) or severe problems (3 points). The second part is visual analogue scale represented by a graduated vertical line from 0 (worst imaginary state of health) to 100 (best imagined state of health). It is validated in Catalan.	12 months