Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03185026
Status:
RECRUITING
Last Update Posted:
2022-10-20
First Post:
2017-05-11
Brief Title:
Psychoeducation for Suicidal Behavior
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Effectiveness of the First French Psychoeducational Program for Suicidal Behavior a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEPSUI
Brief Summary:
The aims of the recent World Health Organization report highlighting that every 40 seconds a person dies from suicide somewhere in the world are to increase awareness on the public health significance of suicide and make suicide prevention a greater priority within the global public health agenda Across age groups less than half of individuals at elevated suicide risk interface with some form of mental health services Several barriers to help-seeking have been identified maladaptive coping lack of perceived need beliefs about treatment effectiveness fear of hospitalization or mistrust of providers stigma which are key targets in knowledge-based interventions on suicide Psychoeducational programs have shown effectiveness in prevention relapse for several mental disorders such as schizophrenia bipolar disorder or recurrent depressive disorder improving treatment adherence and self-confidence in coping with symptoms of the disease They are highly recommended for addressing adherence problems in patients with serious and persistent mental illness Only one team has published a study protocol for a controlled trial assessing a 10 group sessions psychoeducational program for prevention in patients having a suicide history in a one-year follow-up Interestingly diagnosis-mixed group psychoeducation have shown superiority than an unspecific intervention add-on routine care on the suicide prevention and compliance for severe psychiatric disorders Those psychoeducational-specific elements are namely the interactive transfer of illness and treatment-related knowledge and managementcoping - cognitivebehavioral - strategies as defined by the National Institute for Health and Care Excellence-Guidelines NICE Notably as several psychiatric diagnoses are associated with suicidal behavior SB coping strategies have to target processes that overlap among these psychiatric disease as well as suicidal vulnerability Acceptance and Commitment Therapy ACT a third wave behavioral therapy targets experiential avoidance and psychological flexibility at the core of psychiatric disorders Interestingly in patients with a history of suicidal depression training in mindfulness can help to weaken suicidal thinking associated with depressive symptoms and thus reduce an important vulnerability for relapse to suicidal depression ACT would also increase intrinsic motivation for daily life action ie reasons for living and acting Then the functional analysis matrix used in ACT seems to be an useful tool to help patient in decision making a neuropsychological factor impaired in suicidal patients Finally acceptance and commitment group therapy has suggested effectiveness in reducing intensity and frequency of suicidal thoughts through improvement in acceptance in high risk suicidal patients As compared with ACT Dialectical behavior therapy DBT teaches added distress tolerance in view of survive the crisis DBT is the most validated therapy for borderline personality disorder the mental disorder the most associated with SB Notably group skills training is the most effective component in DBT for preventing suicidal behavior in borderline patients with high suicidal risk Furthermore interventions based on positive psychology have suggested efficacy in reducing depressive symptoms and suicidal ideation Notably in a recent pilot study positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains improvement in optimism and hopelessness Finally as altered social link and sense of belonging have been widely involved in SB relationship skills are an interesting positive psychology area for suicide prevention program
Psychoeducational program integrating knowledge as well the last innovating cognitive-behavioral coping strategies for SB is of major interest in suicide prevention
Investigators developed the first French program of suicide psychoeducation called PEPSUI The aim of this innovating program is to teach patients the more recent knowledge about suicidal behaviour SB and effective treatments through didactic and interactive sessions Thus the objective is to conduct the patients to become experts and actors of their disease increasing adherence to treatment Besides the patients will experiment the last innovating psychological skills to cope with unpleasant emotions and thoughts including suicidal thoughts distress tolerance skills and crisis strategies and identify personal purpose in life and learn positive psychological skills in order to anchor with meaningful and pleasant components in life Thus this program will include skills from ACT DBT and positive psychology Finally this primary care research is about a program which aim at improving accessibility to mental health services care adherence and continuity for suicidal patients
Psychoeducational program integrating knowledge as well the last innovating cognitive-behavioral coping strategies for SB is of major interest in suicide prevention
Investigators developed the first French program of suicide psychoeducation called PEPSUI The aim of this innovating program is to teach patients the more recent knowledge about suicidal behaviour SB and effective treatments through didactic and interactive sessions Thus the objective is to conduct the patients to become experts and actors of their disease increasing adherence to treatment Besides the patients will experiment the last innovating psychological skills to cope with unpleasant emotions and thoughts including suicidal thoughts distress tolerance skills and crisis strategies and identify personal purpose in life and learn positive psychological skills in order to anchor with meaningful and pleasant components in life Thus this program will include skills from ACT DBT and positive psychology Finally this primary care research is about a program which aim at improving accessibility to mental health services care adherence and continuity for suicidal patients
Detailed 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 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 ie 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 MINI 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
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 ie 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 MINI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-A00571-52 | OTHER | Agence Nationale de Sécurité du Médicament et des produits de santé FRANCE | None |