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A Psycho-educational Intervention for People With Suicidal in Prisons (N'VIU)

Primary Purpose

Suicide

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psycho-educational intervention
Sponsored by
Consorci Hospitalari de Vic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring suicide, suicide behaviour, suicide prevention, prison environment, psychoeducational intervention, randomized controlled trial

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Vic University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 30, 2021
Last Updated
January 17, 2022
Sponsor
Consorci Hospitalari de Vic
Collaborators
Government of Catalonia
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1. Study Identification

Unique Protocol Identification Number
NCT05195554
Brief Title
A Psycho-educational Intervention for People With Suicidal in Prisons
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Consorci Hospitalari de Vic
Collaborators
Government of Catalonia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
suicide, suicide behaviour, suicide prevention, prison environment, psychoeducational intervention, randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Blind assessment of the response variables.
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive information on suicide and advice if the suicidal ideation increases.
Intervention Type
Other
Intervention Name(s)
Psycho-educational intervention
Intervention Description
Psycho-educational intervention will consist of between 10 and 12 people led by two professionals.
Primary Outcome Measure Information:
Title
Total number of suicidal behaviours
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Suicide risk
Description
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.
Time Frame
12 months
Title
Severity of suicidal ideation
Description
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.
Time Frame
12 months
Title
Depression
Description
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.
Time Frame
12 months
Title
Anxiety
Description
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.
Time Frame
12 months
Title
Quality of life (QOL)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quintí Foguet-Boreu, MD,PhD
Phone
+34938891111
Ext
1706
Email
42292qfb@comb.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quintí Foguet-Boreu, MD,PhD
Organizational Affiliation
Consorci Hospitalari de Vic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vic University Hospital
City
Vic
State/Province
Catalonia
ZIP/Postal Code
08500
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
Citation
Ministerio del Interior. Mortalidad en Instituciones Penitenciària s (II.PP.) Año 2017. Boletín epidemiológico de Instituciones Penitenciària. 2019; 24 (2).
Results Reference
background
Citation
Department of Justice. Penitentiary services. Statistics data 2018. Available at: http://justicia.gencat.cat/ca/departament/Estadistiques/serveis_penitenciaris. Accessed 10 December 2021.
Results Reference
background
Citation
World Health Organization. Preventing suicide in jails and prisons. Geneve: WHO; 2007.
Results Reference
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PubMed Identifier
23303884
Citation
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.
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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
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A Psycho-educational Intervention for People With Suicidal in Prisons

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