Clinical trial NCT03185026: Psychoeducation for Suicidal Behavior
Official title: Effectiveness of the First French Psychoeducational Program for Suicidal Behavior : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicidal Behavior
Keywords: Psychiatry
Suicide
Psychoeducation
Randomized controlled trial
current suicidal behavior disorder
DSM-5
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: CHU Marius Lacroix, Lille, FRANCE
name: CHU Gabriel Montpied, Clermont Ferrand, FRANCE
name: CHU Pasteur, Nice, FRANCE
name: Centre Psychothérapique de Nancy
name: CHU Le Vinatier, Bron, FRANCE
name: CHU Albert Michallon, La Tronche, FRANCE
name: CHU Tarnier, Paris, FRANCE
First posted: 2017-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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, 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.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years
* Having a current suicidal behaviour disorder according to DSM-5 (APA, 2013), i.e. history of suicidal attempt in the past year
* Able to speak, read and understand French.
* Able to give written informed consent
* Having signed informed consent
* Must belong to social safety system

Exclusion Criteria:

* Having a current or past diagnosis of an organic mental disorder
* Having a lifetime history of schizophrenia
* Having a mental retardation
* Planned longer stay outside the region that prevents compliance with the visit plan
* Deprived of liberty Subject (by judicial or administrative decision)
* Protected by law (guardianship)
* Current exclusion period in relation to another protocol

Primary outcomes:
measure: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 2 years after the intervention
Secondary outcomes:
measure: Interrupted suicide attempt rate reduction using the C-SSRS
timeFrame: At 2 years after the intervention
measure: Aborted suicide attempt rate reduction using the C-SSRS
timeFrame: At 2 years after the intervention
measure: Severity of suicide ideation using the C-SSRS
timeFrame: At one week after the intervention
measure: Severity of suicide ideation using the C-SSRS
timeFrame: At 6 months after the intervention
measure: Severity of suicide ideation using the C-SSRS
timeFrame: At 12 months after the intervention
measure: Severity of suicide ideation using the C-SSRS
timeFrame: At 18 months after the intervention
measure: Severity of suicide ideation using the C-SSRS
timeFrame: At 24 months after the intervention
measure: Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At one week after the intervention
measure: Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 6 months after the intervention
measure: Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 12 months after the intervention
measure: Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 18 months after the intervention
measure: Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 24 months after the intervention
measure: Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At one week after the intervention
measure: Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 6 months after the intervention
measure: Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 12 months after the intervention
measure: Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 18 months after the intervention
measure: Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 24 months after the intervention
measure: Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At one week after the intervention
measure: Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 6 months after the intervention
measure: Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 12 months after the intervention
measure: Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 18 months after the intervention
measure: Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 24 months after the intervention
measure: Adherence to treatment using the Medication Adherence Rating Scale (MARS)
timeFrame: At one week after the intervention
measure: Adherence to treatment using the Medication Adherence Rating Scale (MARS)
timeFrame: At 6 months after the intervention
measure: Adherence to treatment using the Medication Adherence Rating Scale (MARS)
timeFrame: At 12 months after the intervention
measure: Adherence to treatment using the Medication Adherence Rating Scale (MARS)
timeFrame: At 18 months after the intervention
measure: Adherence to treatment using the Medication Adherence Rating Scale (MARS)
timeFrame: At 24 months after the intervention
measure: Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
timeFrame: At one week after the intervention
measure: Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
timeFrame: At 6 months after the intervention
measure: Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
timeFrame: At 12 months after the intervention
measure: Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
timeFrame: At 18 months after the intervention
measure: Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
timeFrame: At 24 months after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At one week after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At 6 months after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At 12 months after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At 18 months after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At 24 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At one week after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At 6 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At 12 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At 18 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At 24 months after the intervention
measure: Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
timeFrame: At one week after the intervention
measure: Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
timeFrame: At 6 months after the intervention
measure: Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
timeFrame: At 12 months after the intervention
measure: Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
timeFrame: At 18 months after the intervention
measure: Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
timeFrame: At 24 months after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At one week after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At 6 months after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At 12 months after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At 18 months after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At 24 months after the intervention
measure: Global functioning using the Functioning Assessment Short Test (FAST)
timeFrame: At one week after the intervention
measure: Global functioning using the Functioning Assessment Short Test (FAST)
timeFrame: At 6 months after the intervention
measure: Global functioning using the Functioning Assessment Short Test (FAST)
timeFrame: At 12 months after the intervention
measure: Global functioning using the Functioning Assessment Short Test (FAST)
timeFrame: At 18 months after the intervention
measure: Global functioning using the Functioning Assessment Short Test (FAST)
timeFrame: At 24 months after the intervention
measure: Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
timeFrame: At one week after the intervention
measure: Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
timeFrame: At 6 months after the intervention
measure: Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
timeFrame: At 12 months after the intervention
measure: Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
timeFrame: At 18 months after the intervention
measure: Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
timeFrame: At 24 months after the intervention
measure: Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
timeFrame: At one week after the intervention
measure: Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
timeFrame: At 6 months after the intervention
measure: Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
timeFrame: At 12 months after the intervention
measure: Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
timeFrame: At 18 months after the intervention
measure: Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
timeFrame: At 24 months after the intervention
measure: The need to emergency psychiatric consultation for suicidal ideation
timeFrame: At one week after the intervention
measure: The need to emergency psychiatric hospitalisation for suicidal ideation
timeFrame: At one week after the intervention
measure: The need to emergency psychiatric consultation for suicidal ideation
timeFrame: At 6 months after the intervention
measure: The need to emergency psychiatric hospitalisation for suicidal ideation
timeFrame: At 6 months after the intervention
measure: The need to emergency psychiatric consultation for suicidal ideation
timeFrame: At 12 months after the intervention
measure: The need to emergency psychiatric hospitalisation for suicidal ideation
timeFrame: At 12 months after the intervention
measure: The need to emergency psychiatric consultation for suicidal ideation
timeFrame: At 18 months after the intervention
measure: The need to emergency psychiatric hospitalisation for suicidal ideation
timeFrame: At 18 months after the intervention
measure: The need to emergency psychiatric consultation for suicidal ideation
timeFrame: At 24 months after the intervention
measure: The need to emergency psychiatric hospitalisation for suicidal ideation
timeFrame: At 24 months after the intervention
measure: Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
timeFrame: At one week after the intervention
measure: Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
timeFrame: At 6 months after the intervention
measure: Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
timeFrame: At 12 months after the intervention
measure: Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
timeFrame: At 18 months after the intervention
measure: Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
timeFrame: At 24 months after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At one week after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At 6 months after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At 12 months after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At 18 months after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At 24 months after the intervention
measure: Meaning in life assessment using the Life Regard Index: (LRI)
timeFrame: At one week after the intervention
measure: Meaning in life assessment using the Life Regard Index: (LRI)
timeFrame: At 6 months after the intervention
measure: Meaning in life assessment using the Life Regard Index: (LRI)
timeFrame: At 12 months after the intervention
measure: Meaning in life assessment using the Life Regard Index: (LRI)
timeFrame: At 18 months after the intervention
measure: Meaning in life assessment using the Life Regard Index: (LRI)
timeFrame: At 24 months after the intervention
measure: Satisfaction of the intervention using the Likert scales rating from 0 (not useful at all) to 10 (very useful)
timeFrame: One week after last session of the intervention within 15 days.
measure: Adherence to the intervention (psychoeducational and relaxation ): number of sessions performed by the patient
timeFrame: At one week after the intervention
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
References:
citation: 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.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.