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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284085
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Government of Catalonia
Information provided by (Responsible Party):
Dr. Pere Roura-Poch, Consorci Hospitalari de Vic

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.


Condition or disease Intervention/treatment Phase
Suicide Other: Psychoeducational intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project
Actual Study Start Date : October 15, 2019
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : February 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Intervention group
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.
Other: Psychoeducational intervention
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.

No Intervention: Control group
They will receive a fact sheet on suicide and also tips on how to increase suicidal ideation.



Primary Outcome Measures :
  1. Number of suicidal behaviours [ Time Frame: 12 months ]
    Total number of suicidal behaviors recorded during 12 months after the start of the study in both groups.


Secondary Outcome Measures :
  1. Severity of suicidal ideation [ Time Frame: 6 months ]
    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.

  2. Levels of Anxiety [ Time Frame: 6 months ]
    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.

  3. Levels of depression [ Time Frame: 6 months ]
    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.

  4. Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D [ Time Frame: 6 months ]
    Quality of life (EuroQoL-5D Health Questionnaire, EQ-5D). Score: 0 (worst imagined state of health) to 100 (best imagined state of health).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284085


Locations
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Spain
Vic University Hospital
Vic, Catalonia, Spain, 08500
Sponsors and Collaborators
Consorci Hospitalari de Vic
Government of Catalonia
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Responsible Party: Dr. Pere Roura-Poch, Head of epidemiology, Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier: NCT04284085    
Other Study ID Numbers: AC277
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms