Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Suicidal Behavior
  • Suicide, Attempted
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

The project aims at to compare the effectiveness on suicide re-attempt rate reduction at 2-years follow-up of add-on PEPSUI psychoeducational program versus relaxation program in patients having attempted suicide in the past year Secondary, the project aims to compare between add-on psychoeducationa...

The project aims at to compare the effectiveness on suicide re-attempt rate reduction at 2-years follow-up of add-on PEPSUI psychoeducational program versus relaxation program in patients having attempted suicide in the past year Secondary, the project aims to compare between add-on psychoeducational program and relaxation: Interrupted or aborted suicide attempt rate reduction during the follow-up Severity and intensity of suicide ideation: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Intensity of suicidal intent: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Adherence to treatment and perceived utility of mental health services: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Levels of depression, anxiety, psychological pain and hopelessness: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Global functioning and quality of life: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Subjective social support: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) The need to emergency psychiatric consultation and psychiatric hospitalisation for suicidal ideation: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Acceptance, contact with present moment and meaning in life: at post-treatment, and at 6, 12, 18 and 24 months after the intervention (and the evolution between pre and each post-intervention point) Satisfaction and adherence to the intervention: at post-treatment (likert scale). 500 patients suffering from current suicidal behavior disorder (according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) will be recruited, i.e. having attempted to suicide in the past year. Eligible patients will be randomized in one of the two arms: add-on psychoeducation or add-on relaxation (computer-generated randomisation in a 1 :1 ratio). Sociodemographic data, psychiatric diagnoses using Mini-International Neuropsychiatric Interview (M.I.N.I.) and pharmacological treatment will be also recorded. An independent researcher not involved in the study will perform the allocation. Each patient will be evaluated at baseline (pre intervention V1) and followed-up during 24 months after treatment completion, with 5 visits: post intervention (V2) 6 months (V3), 12 months (V4), 18 months (V5) and 24 months (V6) after the intervention. Blind trained evaluators will assess patients. Patients will be told to avoid saying their group of allocation to the evaluator.

Tracking Information

NCT #
NCT03185026
Collaborators
  • CHU Marius Lacroix, Lille, FRANCE
  • CHU Gabriel Montpied, Clermont Ferrand, FRANCE
  • CHU Pasteur, Nice, FRANCE
  • Centre Psychothérapique de Nancy, FRANCE
  • CHU Le Vinatier, Bron, FRANCE
  • CHU Albert Michallon, La Tronche, FRANCE
  • CHU Tarnier, Paris, FRANCE
Investigators
Not Provided