Suicide, AttemptedPEPSUINCT03185026
Psychoeducation for Suicidal Behavior
A study testing Interventional group : PEPSUI psychoeducational program and Relaxation group in people with Suicide, Attempted and Suicidal Behavior, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Attempted, Suicidal Behavior
- What is being tested?
- Interventional group : PEPSUI psychoeducational program and Relaxation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2017to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
DEBORAH DUCASSE, MD, 632601595 ext. 33, d-ducasse@chu-montpellier.fr
CATHERINE GENTY, MD, 4 99614575 ext. 33, c-genty@chu-montpellier.fr
About this study
Official title: Effectiveness of the First French Psychoeducational Program for Suicidal Behavior : a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Suicide, Attempted, Suicidal Behavior
- Being tested
- Interventional group : PEPSUI psychoeducational program, Relaxation group
- Keywords
- Psychiatry, Suicide, Psychoeducation, Randomized controlled trial, current suicidal behavior disorder, DSM-5
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional group : PEPSUI psychoeducational programBehavioural
The program includes 10 weekly, 2-hours sessions led by two trained animators (nurse, medical doctor/psychologist), each focusing on a specific theme or skill :
- Education on suicidal behavior (clinic and epidemiology), and conceptualization of the phenomenon on a matrix
- Education on the suicidal crisis, identification of important life areas and values for the patient, experimentation on the way to use the matrix as a decision-making tool.
- and 4) Self-assessment of suicidal ideations, coping strategies based on suicide ideation intensity and emotional tension (acceptation, distress tolerance, personal aid kit, and emergency care)
- Stress-diathesis model of suicidal behavior, innovating cognitive skills (defusion), and valued actions 6) Stress factors (psychiatric diseases and negative life events), resilience, and contact with present moment 7) Suicidal vulnerability, personal strengths 8) Social support, skills to create quality relationships
Relaxation groupOther
Participants will be included in a standardized relaxation program, consisting of 10 weekly sessions lasting 2 hours. There will be 2 therapists for each patients group. Abdominal and muscular relaxation skills will be experimented.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation group | Active comparator | Participants will be included in a standardized relaxation program, consisting of 10 weekly sessions lasting 2 hours. There will be 2 therapists for each patients group. Abdominal and muscular relaxation skills will be experimented. Receives: Other: Relaxation group |
| Psychoeducational group | Experimental | The patients will experiment the last innovating psychological skills in order to acquire the ability to engage in behaviors to manage their disease. Receives: Behavioral: Interventional group : PEPSUI psychoeducational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS)
Comparison of suicide re-attempt rate reduction, at 2 years follow-up, between PEPSUI and relaxation groups.
Measured: At 2 years after the intervention
Secondary outcomes (94)
Interrupted suicide attempt rate reduction using the C-SSRS
Comparison of suicide re-attempt rate reduction, at 2 years follow-up, between PEPSUI and relaxation groups.
Measured: At 2 years after the intervention
Aborted suicide attempt rate reduction using the C-SSRS
Comparison of suicide re-attempt rate reduction, at 2 years follow-up, between PEPSUI and relaxation groups.
Measured: At 2 years after the intervention
Severity of suicide ideation using the C-SSRS
Comparison of the severity of suicide ideation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Severity of suicide ideation using the C-SSRS
Comparison of the severity of suicide ideation between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation)
Measured: At 6 months after the intervention
Severity of suicide ideation using the C-SSRS
Comparison of the severity of suicide ideation between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Severity of suicide ideation using the C-SSRS
: Comparison of the severity of suicide ideation between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Severity of suicide ideation using the C-SSRS
Comparison of the severity of suicide ideation between pre-treatment and 24 months post-intervention within the two groups (PEPSUI vs Relaxation).
Measured: At 24 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the severity of suicide ideation between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the severity of suicide ideation between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the severity of suicide ideation between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the severity of suicide ideation between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the severity of suicide ideation between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Comparison of the intensity of suicide ideation between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Comparison of the intensity of suicide ideation between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Comparison of the intensity of suicide ideation between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Comparison of the intensity of suicide ideation between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Comparison of the intensity of suicide ideation between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the intensity of suicidal intent between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the intensity of suicidal intent between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the intensity of suicidal intent between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the intensity of suicidal intent between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Comparison of the intensity of suicidal intent between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Comparison of the pharmacological adherence between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Comparison of the pharmacological adherence between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Comparison of the pharmalogical adherence between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Comparison of the pharmacological adherence between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation)
Measured: At 18 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Comparison of the pharmacological adherence between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Comparison of the number of missed consultations between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Comparison of the number of missed consultations between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Comparison of the number of missed consultations between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Comparison of the number of missed consultations between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Comparison of the number of missed consultations between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Comparison of the intensity of depression between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Comparison of the intensity of depression between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Comparison of the intensity of depression between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Comparison of the intensity of depression between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Comparison of the intensity of depression between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Comparison of the state of anxiety between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Comparison of the state of anxiety between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Comparison of the state of anxiety between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Comparison of the state of anxiety between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Comparison of the state of anxiety between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
Comparison of the psychological pain between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
Comparison of the psychological pain between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
Comparison of the psychological pain between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
Comparison of the psychological pain between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Psychological pain using the Likert scales from 0 (none) to 10 (maximum possible pain)
Comparison of the psychological pain between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
Comparison of the hopelessness between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
Comparison of the hopelessness between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
Comparison of the hopelessness between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
Comparison of the hopelessness between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
Comparison of the hopelessness between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Global functioning using the Functioning Assessment Short Test (FAST)
Comparison of the global functioning between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Global functioning using the Functioning Assessment Short Test (FAST)
Comparison of the global functioning between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Global functioning using the Functioning Assessment Short Test (FAST)
Comparison of the global functioning between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Global functioning using the Functioning Assessment Short Test (FAST)
Comparison of the global functioning between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Global functioning using the Functioning Assessment Short Test (FAST)
Comparison of the global functioning between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
Comparison of the quality of life between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
Comparison of the quality of life between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
Comparison of the quality of life between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
Comparison of the quality of life between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Quality of life evaluated by the World Health Organization Quality Of Life measure (WHOQOL-BREF) instrument
Comparison of the quality of life between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
Comparison of the subjective social support between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
Comparison of the subjective social support between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
Comparison of the subjective social support between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
Comparison of the subjective social support between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Subjective social support using a Likert scale, from 0 (very poor quality) to 10 (excellent quality)
Comparison of the subjective social support between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
The need to emergency psychiatric consultation for suicidal ideation
Comparison of need to emergency psychiatric consultation between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
The need to emergency psychiatric hospitalisation for suicidal ideation
Comparison of need to emergency psychiatric hospitalisation between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
The need to emergency psychiatric consultation for suicidal ideation
Comparison of need to emergency psychiatric consultation between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
The need to emergency psychiatric hospitalisation for suicidal ideation
Comparison of need to emergency psychiatric hospitalisation between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
The need to emergency psychiatric consultation for suicidal ideation
Comparison of need to emergency psychiatric consultation between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
The need to emergency psychiatric hospitalisation for suicidal ideation
Comparison of need to emergency psychiatric hospitalisation between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
The need to emergency psychiatric consultation for suicidal ideation
Comparison of need to emergency psychiatric consultation between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
The need to emergency psychiatric hospitalisation for suicidal ideation
Comparison of need to emergency psychiatric hospitalisation between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
The need to emergency psychiatric consultation for suicidal ideation
Comparison of need to emergency psychiatric consultation between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
The need to emergency psychiatric hospitalisation for suicidal ideation
Comparison of need to emergency psychiatric hospitalisation between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
Comparison of the acceptance between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
Comparison of the acceptance between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
Comparison of the acceptance between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
Comparison of the acceptance between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Acceptance assessment using the acceptance and Action Questionnaire (AAQII)
Comparison of the acceptance between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Comparison of the contact with the present moment between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Comparison of the contact with the present moment between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Comparison of the contact with the present moment between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Comparison of the contact with the present moment between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Comparison of the contact with the present moment between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Meaning in life assessment using the Life Regard Index: (LRI)
Comparison of the meaning in life between pre-treatment and one week post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At one week after the intervention
Meaning in life assessment using the Life Regard Index: (LRI)
Comparison of the meaning in life between pre-treatment and 6 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 6 months after the intervention
Meaning in life assessment using the Life Regard Index: (LRI)
Comparison of the meaning in life between pre-treatment and 12 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 12 months after the intervention
Meaning in life assessment using the Life Regard Index: (LRI)
Comparison of the meaning in life between pre-treatment and 18 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 18 months after the intervention
Meaning in life assessment using the Life Regard Index: (LRI)
Comparison of the meaning in life between pre-treatment and 24 months post-intervention within the two groups (PEPSUI versus Relaxation).
Measured: At 24 months after the intervention
Satisfaction of the intervention using the Likert scales rating from 0 (not useful at all) to 10 (very useful)
Evaluation of the satisfaction about the intervention within the two groups (PEPSUI versus Relaxation).
Measured: One week after last session of the intervention within 15 days.
Adherence to the intervention (psychoeducational and relaxation ): number of sessions performed by the patient
Comparison of adherence to the intervention within the two groups (PEPSUI versus Relaxation) assessed by the number of sessions performed by patients
Measured: At one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start6 Sep 2017
- Primary completion6 May 2026 (estimated)
- Study completion6 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- CHU Marius Lacroix, Lille, FRANCE, CHU Gabriel Montpied, Clermont Ferrand, FRANCE, Centre Hospitalier Universitaire de Nice, Centre Psychothérapique de Nancy, CHU Le Vinatier, Bron, FRANCE, CHU Albert Michallon, La Tronche, FRANCE, CHU Tarnier, Paris, FRANCE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185026
- Sponsor's protocol ID
- 9808
- Other IDs
- 2017-A00571-52
- Acronym
- PEPSUI
- Status last verified
- Aug 2024
- First submitted
- 11 May 2017
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33884617Storebo 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.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the First French Psychoeducational Program for Suicidal Behavior : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03185026
- Acronym / sponsor ID
- PEPSUI / 9808
- Conditions
- Suicide, Attempted, Suicidal Behavior
- Keywords
- Psychiatry, Suicide, Psychoeducation, Randomized controlled trial, current suicidal behavior disorder, DSM-5
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- CHU Marius Lacroix, Lille, FRANCE, CHU Gabriel Montpied, Clermont Ferrand, FRANCE, Centre Hospitalier Universitaire de Nice, Centre Psychothérapique de Nancy, CHU Le Vinatier, Bron, FRANCE, CHU Albert Michallon, La Tronche, FRANCE, CHU Tarnier, Paris, FRANCE
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 6 May 2026 (estimated)
- Study completion
- 6 May 2026 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation group | Active comparator | Other: Relaxation groupParticipants will be included in a standardized relaxation program, consisting of 10 weekly sessions lasting 2 hours. There will be 2 therapists for each patients group. Abdominal and muscular relaxation skills will be experimented. |
| Psychoeducational group | Experimental | Behavioral: Interventional group : PEPSUI psychoeducational programThe patients will experiment the last innovating psychological skills in order to acquire the ability to engage in behaviors to manage their disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional group : PEPSUI psychoeducational programThe program includes 10 weekly, 2-hours sessions led by two trained animators (nurse, medical doctor/psychologist), each focusing on a specific theme or skill : 1. Education on suicidal behavior (clinic and epidemiology), and conceptualization of the phenomenon on a matrix 2. Education on the suicidal crisis, identification of important life areas and values for the patient, experimentation on the way to use the matrix as a decision-making tool. 3. and 4) Self-assessment of suicidal ideations, coping strategies based on suicide ideation intensity and emotional tension (acceptation, distress tolerance, personal aid kit, and emergency care) 5) Stress-diathesis model of suicidal behavior, innovating cognitive skills (defusion), and valued actions 6) Stress factors (psychiatric diseases and negative life events), resilience, and contact with present moment 7) Suicidal vulnerability, personal strengths 8) Social support, skills to create quality relationships | Behavioural | Psychoeducational group |
| Relaxation groupParticipants will be included in a standardized relaxation program, consisting of 10 weekly sessions lasting 2 hours. There will be 2 therapists for each patients group. Abdominal and muscular relaxation skills will be experimented. | Other | Relaxation group |
Primary outcome
Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At 2 years after the intervention
Comparison of suicide re-attempt rate reduction, at 2 years follow-up, between PEPSUI and relaxation groups.
94 secondary outcomes
Interrupted suicide attempt rate reduction using the C-SSRS
Time frame: At 2 years after the intervention
Aborted suicide attempt rate reduction using the C-SSRS
Time frame: At 2 years after the intervention
Severity of suicide ideation using the C-SSRS
Time frame: At one week after the intervention
Severity of suicide ideation using the C-SSRS
Time frame: At 6 months after the intervention
Severity of suicide ideation using the C-SSRS
Time frame: At 12 months after the intervention
Severity of suicide ideation using the C-SSRS
Time frame: At 18 months after the intervention
Severity of suicide ideation using the C-SSRS
Time frame: At 24 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At one week after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 6 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 12 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 18 months after the intervention
Severity of suicide ideation evaluated by the likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 24 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At one week after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At 6 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At 12 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At 18 months after the intervention
Intensity of suicide ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At 24 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At one week after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 6 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 12 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 18 months after the intervention
Intensity of suicide ideation using the likert scales, from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 24 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Time frame: At one week after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Time frame: At 6 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Time frame: At 12 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Time frame: At 18 months after the intervention
Adherence to treatment using the Medication Adherence Rating Scale (MARS)
Time frame: At 24 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Time frame: At one week after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Time frame: At 6 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Time frame: At 12 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Time frame: At 18 months after the intervention
Perceived utility of mental health services using the likert scales rating from 0 (not useful at all) to 10 (very useful)
Time frame: At 24 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Time frame: At one week after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Time frame: At 6 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Time frame: At 12 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Time frame: At 18 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Time frame: At 24 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Time frame: At one week after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Time frame: At 6 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Time frame: At 12 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 32368793Storebo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional group : PEPSUI psychoeducational program and Relaxation group in people with Suicide, Attempted and Suicidal Behavior, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Déborah DUCASSE, MD (00 33 4 67 33 82 89, d-ducasse@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: At 2 years after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.