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Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project (N'VIU)

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychoeducational intervention
Sponsored by
Consorci Hospitalari de Vic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

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

Inclusion Criteria:

-People who have attempted suicide or a risk of suicide moderate to high.

Exclusion Criteria:

  • People with a mental disorder in a state of acute exacerbation
  • Intellectual disability
  • Cognitive impairment

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

There will be psycho-educational groups of 10 to 12 people, led by two professionals, one of them will always be a psychologist and an educator. In some sessions, other collaborators will be invited to participate, such as psychiatrists, educators, social workers, etc. who may act as external observers or implement the session. The number of sessions will be 13, one or two sessions a week and duration of 90 minutes.

They will receive a fact sheet on suicide and also tips on how to increase suicidal ideation.

Outcomes

Primary Outcome Measures

Number of suicidal behaviours
Total number of suicidal behaviors recorded during 12 months after the start of the study in both groups.

Secondary Outcome Measures

Severity of suicidal ideation
Severity of suicidal ideation (Columbia-Suicide Severity Rating Scale, C-SSRS). Intensity of Ideation subscale, the total score ranges from 2 to 25,with a higher number indicating more intense ideation and greater risk.
Levels of Anxiety
Hamilton Anxiety Rating Scale (HARS): Total score range of 0-56, where <17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe.
Levels of depression
Hamilton Depression Rating Scale (HDRS). Score: 0-7: No depression; 8-13: Mild depression; 14-18: Moderate depression; 19-22: Severe depression and ≥ 23: Very severe depression.
Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D
Quality of life (EuroQoL-5D Health Questionnaire, EQ-5D). Score: 0 (worst imagined state of health) to 100 (best imagined state of health).

Full Information

First Posted
February 17, 2020
Last Updated
February 21, 2020
Sponsor
Consorci Hospitalari de Vic
Collaborators
Government of Catalonia
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1. Study Identification

Unique Protocol Identification Number
NCT04284085
Brief Title
Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project
Acronym
N'VIU
Official Title
Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
February 17, 2020 (Actual)

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

5. Study Description

Brief Summary
Objective. The main objective is to determine the effectiveness of a psychoeducational program conducted by rehabilitation professionals to reduce the number of suicidal behaviors in prisons. Methodology. The design of the study will be a multicenter, randomized, two-group clinical trial with blind evaluation of response variables, one year follow-up. The study population will be a male and female prison population of a total of two Catalan prisons. As a dependent or outcome variable, the total number of suicidal behaviors recorded for 12 months after the intervention will be determined. As independent variables, socio-demographic, clinical and prison situation variables will be collected. The suicidal ideation will be measured with the Columbia-Suicide Severity Rating Scale (C-SSRS). The anxiety and depression with Hamilton scale for assessing anxiety (HDRS) and the Hamilton scale for assessing severity of depressive symptoms (HAM-D). The EuroQoL-5D Health Questionnaire (EQ-5D) to measure quality of life. And a satisfaction survey of psychoeducational group intervention. Participants who meet the inclusion criteria will be divided into two groups, an intervention group that will conduct group sessions with a frequency of two per week and duration of 90 minutes for a total of 13 sessions, and a control group that will receive information on suicide counseling. Discussion. Mortality from suicide is higher in the prison population than in the general population. This project aims to evaluate the effect of a psychoeducational intervention on reducing the number of suicidal behaviors in prison, in order to evaluate their implementation at the level of the entire prison network.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
There will be psycho-educational groups of 10 to 12 people, led by two professionals, one of them will always be a psychologist and an educator. In some sessions, other collaborators will be invited to participate, such as psychiatrists, educators, social workers, etc. who may act as external observers or implement the session. The number of sessions will be 13, one or two sessions a week and duration of 90 minutes.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
They will receive a fact sheet on suicide and also tips on how to increase suicidal ideation.
Intervention Type
Other
Intervention Name(s)
Psychoeducational intervention
Intervention Description
Psycho-educational groups of 10 to 12 people, led by two professionals, one of them will always be a psychologist and an educator. In some sessions, other collaborators will be invited to participate, such as psychiatrists, educators, social workers, etc. who may act as external observers or implement the session. The number of sessions will be 13, one or two sessions a week and duration of 90 minutes.
Primary Outcome Measure Information:
Title
Number of suicidal behaviours
Description
Total number of suicidal behaviors recorded during 12 months after the start of the study in both groups.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Severity of suicidal ideation
Description
Severity of suicidal ideation (Columbia-Suicide Severity Rating Scale, C-SSRS). Intensity of Ideation subscale, the total score ranges from 2 to 25,with a higher number indicating more intense ideation and greater risk.
Time Frame
6 months
Title
Levels of Anxiety
Description
Hamilton Anxiety Rating Scale (HARS): Total score range of 0-56, where <17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe.
Time Frame
6 months
Title
Levels of depression
Description
Hamilton Depression Rating Scale (HDRS). Score: 0-7: No depression; 8-13: Mild depression; 14-18: Moderate depression; 19-22: Severe depression and ≥ 23: Very severe depression.
Time Frame
6 months
Title
Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D
Description
Quality of life (EuroQoL-5D Health Questionnaire, EQ-5D). Score: 0 (worst imagined state of health) to 100 (best imagined state of health).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -People who have attempted suicide or a risk of suicide moderate to high. Exclusion Criteria: People with a mental disorder in a state of acute exacerbation Intellectual disability Cognitive impairment
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:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived

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Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project

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