SuicideN'VIUNCT05195554
A Psycho-educational Intervention for People With Suicidal in Prisons
A study testing Psycho-educational intervention in people with Suicide, run by Consorci Hospitalari de Vic at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Suicide
- What is being tested?
- Psycho-educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have presented some kind of suicidal or high-risk behavior in the criterion of self-directed violence according to the RisCanvi*.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Psycho-educational Intervention for People With Suicidal Conduct in the Prison Environment. N'VIU Project: a Randomized Control Trial
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Psycho-educational intervention
- Keywords
- suicide, suicide behaviour, suicide prevention, prison environment, psychoeducational intervention, randomized controlled trial
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational interventionOther
Psycho-educational intervention will consist of between 10 and 12 people led by two professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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). Receives: Other: Psycho-educational intervention |
| Control group | No intervention | Participants in the control group will receive information on suicide and advice if the suicidal ideation increases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Hospitalari de Vic
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Catalonia
- Responsible party
- Principal investigator, Dr. Pere Roura-Poch, Consorci Hospitalari de Vic
- Investigators
- Quintí Foguet-Boreu, MD,PhD, Principal investigator, Consorci Hospitalari de Vic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195554
- Sponsor's protocol ID
- 2021059
- Acronym
- N'VIU
- Status last verified
- Jan 2022
- First submitted
- 30 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Ministerio del Interior. Mortalidad en Instituciones Penitenciària s (II.PP.) Año 2017. Boletín epidemiológico de Instituciones Penitenciària. 2019; 24 (2).
Department of Justice. Penitentiary services. Statistics data 2018. Available at: http://justicia.gencat.cat/ca/departament/Estadistiques/serveis_penitenciaris. Accessed 10 December 2021.
World Health Organization. Preventing suicide in jails and prisons. Geneve: WHO; 2007.
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.
PubMed 23303884Ferrando 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
Zhong S, Senior M, Yu R, Perry A, Hawton K, Shaw J, Fazel S. Risk factors for suicide in prisons: a systematic review and meta-analysis. Lancet Public Health. 2021 Mar;6(3):e164-e174. doi: 10.1016/S2468-2667(20)30233-4. Epub 2021 Feb 10.
PubMed 33577780Cramer RJ, Wechsler HJ, Miller SL, Yenne E. Suicide Prevention in Correctional Settings: Current Standards and Recommendations for Research, Prevention, and Training. J Correct Health Care. 2017 Jul;23(3):313-328. doi: 10.1177/1078345817716162. Epub 2017 Jun 28.
PubMed 28656789Pratt D, Tarrier N, Dunn G, Awenat Y, Shaw J, Ulph F, Gooding P. Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial. Psychol Med. 2015 Dec;45(16):3441-51. doi: 10.1017/S0033291715001348. Epub 2015 Jul 13.
PubMed 26165919Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989 Mar;27(3 Suppl):S178-89. doi: 10.1097/00005650-198903001-00015.
PubMed 2646488Leidenfrost CM, Schoelerman RM, Maher M, Antonius D. The development and efficacy of a group intervention program for individuals with serious mental illness in jail. Int J Law Psychiatry. 2017 Sep-Oct;54:98-106. doi: 10.1016/j.ijlp.2017.06.004. Epub 2017 Jun 24.
PubMed 28655427Winicov N. A systematic review of behavioral health interventions for suicidal and self-harming individuals in prisons and jails. Heliyon. 2019 Sep 6;5(9):e02379. doi: 10.1016/j.heliyon.2019.e02379. eCollection 2019 Sep.
PubMed 31517115Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.
PubMed 30714749Eck M, Scouflaire T, Debien C, Amad A, Sannier O, Chan Chee C, Thomas P, Vaiva G, Fovet T. [Suicide in prison: Epidemiology and prevention]. Presse Med. 2019 Jan;48(1 Pt 1):46-54. doi: 10.1016/j.lpm.2018.11.009. Epub 2019 Jan 23. French.
PubMed 30685227Foguet-Boreu Q, Capdevila-Capdevila M, Pons-Banos J, Riesco-Miranda L, Sanjuan Torres A, Martinez Garcia M, Framis-Ferrer B, Valdivieso Munoz S. Effectiveness of a psychoeducational intervention for people with suicidal behavior in the prison environment. N'VIU project: a randomized control trial. Health Justice. 2025 Nov 24;13(1):71. doi: 10.1186/s40352-025-00383-z.
PubMed 41284213
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Psycho-educational Intervention for People With Suicidal Conduct in the Prison Environment. N'VIU Project: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05195554
- Acronym / sponsor ID
- N'VIU / 2021059
- Conditions
- Suicide
- Keywords
- suicide, suicide behaviour, suicide prevention, prison environment, psychoeducational intervention, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Consorci Hospitalari de VicUniversity, hospital or other
- Collaborators
- Government of Catalonia
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Psycho-educational interventionThe 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). |
| Control group | No intervention | –Participants in the control group will receive information on suicide and advice if the suicidal ideation increases. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who have presented some kind of suicidal or high-risk behavior in the criterion of self-directed violence according to the RisCanvi*.
Key exclusion criteria (5 listed)
- Decompensation of severe mental disorder
- Intellectual disability
- Cognitive impairment.
- Isolation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educational interventionPsycho-educational intervention will consist of between 10 and 12 people led by two professionals. | Other | Intervention group |
Primary outcome
Total number of suicidal behaviours
Time frame: 12 months
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.
5 secondary outcomes
Suicide risk
Time frame: 12 months
Severity of suicidal ideation
Time frame: 12 months
Depression
Time frame: 12 months
Anxiety
Time frame: 12 months
Quality of life (QOL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- BackgroundSuicide 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.
- BackgroundMinisterio del Interior. Mortalidad en Instituciones Penitenciària s (II.PP.) Año 2017. Boletín epidemiológico de Instituciones Penitenciària. 2019; 24 (2).
- BackgroundDepartment of Justice. Penitentiary services. Statistics data 2018. Available at: http://justicia.gencat.cat/ca/departament/Estadistiques/serveis_penitenciaris. Accessed 10 December 2021.
- BackgroundWorld Health Organization. Preventing suicide in jails and prisons. Geneve: WHO; 2007.
- Background: PubMed 23303884Chan 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.
- BackgroundFerrando 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
- Results publication: PubMed 33577780Zhong S, Senior M, Yu R, Perry A, Hawton K, Shaw J, Fazel S. Risk factors for suicide in prisons: a systematic review and meta-analysis. Lancet Public Health. 2021 Mar;6(3):e164-e174. doi: 10.1016/S2468-2667(20)30233-4. Epub 2021 Feb 10.
- Results publication: PubMed 28656789Cramer RJ, Wechsler HJ, Miller SL, Yenne E. Suicide Prevention in Correctional Settings: Current Standards and Recommendations for Research, Prevention, and Training. J Correct Health Care. 2017 Jul;23(3):313-328. doi: 10.1177/1078345817716162. Epub 2017 Jun 28.
- Results publication: PubMed 26165919Pratt D, Tarrier N, Dunn G, Awenat Y, Shaw J, Ulph F, Gooding P. Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial. Psychol Med. 2015 Dec;45(16):3441-51. doi: 10.1017/S0033291715001348. Epub 2015 Jul 13.
- Results publication: PubMed 2646488Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989 Mar;27(3 Suppl):S178-89. doi: 10.1097/00005650-198903001-00015.
- Results publication: PubMed 28655427Leidenfrost CM, Schoelerman RM, Maher M, Antonius D. The development and efficacy of a group intervention program for individuals with serious mental illness in jail. Int J Law Psychiatry. 2017 Sep-Oct;54:98-106. doi: 10.1016/j.ijlp.2017.06.004. Epub 2017 Jun 24.
- Results publication: PubMed 31517115Winicov N. A systematic review of behavioral health interventions for suicidal and self-harming individuals in prisons and jails. Heliyon. 2019 Sep 6;5(9):e02379. doi: 10.1016/j.heliyon.2019.e02379. eCollection 2019 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quintí Foguet-Boreu, MD,PhD principal investigator
Consorci Hospitalari de Vic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-educational intervention in people with Suicide, run by Consorci Hospitalari de Vic at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quintí Foguet-Boreu, MD,PhD (+34938891111 ext. 1706, 42292qfb@comb.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of suicidal behaviours (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195554, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.