A Psycho-educational Intervention for People With Suicidal in Prisons

Study Overview
=================
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.

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

Conditions
-----------------
Suicide

Intervention / Treatment
-----------------
* Other: Psycho-educational intervention


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Psycho-educational intervention will consist of between 10 and 12 people led by two professionals.<br>|
| No Intervention: Control group<br>Participants in the control group will receive information on suicide and advice if the suicidal ideation increases. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suicide, suicide behaviour, suicide prevention, prison environment, psychoeducational intervention, randomized controlled trial