Psychoeducation for Suicidal Behavior — PEPSUI  

Suicide, Attempted Clinical Trial

Official title: Effectiveness of the First French Psychoeducational Program for Suicidal Behavior : a Randomized Controlled Trial

Status Recruiting

Clinical Trial 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 management/coping - cognitive/behavioral - 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 (i.e. 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.

Clinical Trial 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, 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. ;

Related Conditions & MeSH terms

• Suicidal Behavior
• Suicide
• Suicide, Attempted

• NCT number: NCT03185026
• Study type: Interventional
• Source: University Hospital, Montpellier
• Contact: Déborah DUCASSE, MD
• Phone: 00 33 4 67 33 82 89
• Email: d-ducasse@chu-montpellier.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2017
• Completion date: March 6, 2024