Suicide, Attempted Clinical Trial
— PEPSUIOfficial 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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | March 6, 2024 |
Est. primary completion date | March 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Uh Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Centre Psychothérapique de Nancy, FRANCE, CHU Albert Michallon, La Tronche, FRANCE, CHU Gabriel Montpied, Clermont Ferrand, FRANCE, CHU Le Vinatier, Bron, FRANCE, CHU Marius Lacroix, Lille, FRANCE, CHU Pasteur, Nice, FRANCE, CHU Tarnier, Paris, FRANCE |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At 2 years after the intervention | |
Secondary | 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. | At 2 years after the intervention | |
Secondary | 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. | At 2 years after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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) | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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) | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | At one week after the intervention | |
Secondary | 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). | At 6 months after the intervention | |
Secondary | 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). | At 12 months after the intervention | |
Secondary | 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). | At 18 months after the intervention | |
Secondary | 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). | At 24 months after the intervention | |
Secondary | 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). | One week after last session of the intervention within 15 days. | |
Secondary | 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 | At one week after the intervention |
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