Clinical trial NCT05195554: A Psycho-educational Intervention for People With Suicidal 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Keywords: suicide
suicide behaviour
suicide prevention
prison environment
psychoeducational intervention
randomized controlled trial
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
Collaborators: name: Government of Catalonia
First posted: 2022-01-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Total number of suicidal behaviours
timeFrame: 12 months
Secondary outcomes:
measure: Suicide risk
timeFrame: 12 months
measure: Severity of suicidal ideation
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Anxiety
timeFrame: 12 months
measure: Quality of life (QOL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Vic University Hospital
state: Catalonia
Study officials:
affiliation: Consorci Hospitalari de Vic
name: Quintí Foguet-Boreu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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