NCT04284085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 17, 2020

Last Update Submit

February 21, 2020

Conditions

Suicide

Outcome Measures

Primary Outcomes (1)

  • Number of suicidal behaviours

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

    12 months

Secondary Outcomes (4)

  • Severity of suicidal ideation

    6 months

  • Levels of Anxiety

    6 months

  • Levels of depression

    6 months

  • Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Psychoeducational interventionOTHER

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vic University Hospital

Vic, Catalonia, 08500, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33884617DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of epidemiology

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 25, 2020

Study Start

October 15, 2019

Primary Completion

January 20, 2020

Study Completion

February 17, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)