Psychoeducation for Suicidal Behavior

NCT03185026 | Recruiting

• 2 other identifiers: 98082017-A00571-52
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the recent World Health Organization report, highlighting that every 40 seconds a person dies from suicide somewhere in the world, are to increase awareness on the public health significance of suicide and make suicide prevention a greater priority within the global public health agenda. Across age groups, less than half of individuals at elevated suicide risk interface with some form of mental health services. Several barriers to help-seeking have been identified (maladaptive coping, lack of perceived need, beliefs about treatment effectiveness, fear of hospitalization or mistrust of providers, stigma...), which are key targets in knowledge-based interventions on suicide. Psychoeducational programs have shown effectiveness in prevention relapse for several mental disorders such as schizophrenia, bipolar disorder or recurrent depressive disorder, improving treatment adherence and self-confidence in coping with symptoms of the disease. They are highly recommended for addressing adherence problems in patients with serious and persistent mental illness. Only one team has published a study protocol for a controlled trial assessing a 10 group sessions psychoeducational program for prevention in patients having a suicide history, in a one-year follow-up. Interestingly, diagnosis-mixed group psychoeducation have shown superiority than an unspecific intervention add-on routine care, on the suicide prevention and compliance for severe psychiatric disorders. Those psychoeducational-specific elements are namely the interactive transfer of illness and treatment-related knowledge and management/coping - cognitive/behavioral - strategies, as defined by the National Institute for Health and Care Excellence)-Guidelines (NICE). Notably, as several psychiatric diagnoses are associated with suicidal behavior (SB), coping strategies have to target processes that overlap among these psychiatric disease, as well as suicidal vulnerability. Acceptance and Commitment Therapy (ACT), a "third wave" behavioral therapy, targets experiential avoidance and psychological flexibility, at the core of psychiatric disorders. Interestingly, in patients with a history of suicidal depression, training in mindfulness can help to weaken suicidal thinking associated with depressive symptoms , and thus reduce an important vulnerability for relapse to suicidal depression. ACT would also increase intrinsic motivation for daily life action (i.e. reasons for living and acting). Then, the functional analysis (matrix) used in ACT seems to be an useful tool to help patient in decision making, a neuropsychological factor impaired in suicidal patients. Finally, acceptance and commitment group therapy has suggested effectiveness in reducing intensity and frequency of suicidal thoughts, through improvement in acceptance, in high risk suicidal patients. As compared with ACT, Dialectical behavior therapy (DBT) teaches added distress tolerance in view of survive the crisis. DBT is the most validated therapy for borderline personality disorder, the mental disorder the most associated with SB . Notably, group skills training is the most effective component in DBT for preventing suicidal behavior in borderline patients with high suicidal risk. Furthermore, interventions based on positive psychology have suggested efficacy in reducing depressive symptoms and suicidal ideation. Notably, in a recent pilot study, positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains improvement in optimism and hopelessness. Finally, as altered social link and sense of belonging have been widely involved in SB, relationship skills are an interesting positive psychology area for suicide prevention program. Psychoeducational program integrating knowledge as well the last innovating cognitive-behavioral coping strategies for SB is of major interest in suicide prevention. Investigators developed the first French program of suicide psychoeducation called "PEPSUI". The aim of this innovating program is to teach patients the more recent knowledge about suicidal behaviour (SB) and effective treatments, through didactic and interactive sessions. Thus, the objective is to conduct the patients to become experts and actors of their disease, increasing adherence to treatment. Besides, the patients will experiment the last innovating psychological skills to cope with unpleasant emotions and thoughts (including suicidal thoughts), distress tolerance skills and crisis strategies, and identify personal purpose in life and learn positive psychological skills in order to anchor with meaningful and pleasant components in life. Thus, this program will include skills from ACT, DBT and positive psychology. Finally, this primary care research is about a program which aim at improving accessibility to mental health services, care adherence and continuity for suicidal patients.

Conditions

Suicide, Attempted; Suicidal Behavior

Keywords

Psychiatry; Suicide; Psychoeducation; Randomized controlled trial; current suicidal behavior disorder; DSM-5

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (94)

• Interrupted suicide attempt rate reduction using the C-SSRS

  At 2 years after the intervention

• Aborted suicide attempt rate reduction using the C-SSRS

  At 2 years after the intervention

• Severity of suicide ideation using the C-SSRS

  At one week after the intervention

• Severity of suicide ideation using the C-SSRS

  At 6 months after the intervention

• Severity of suicide ideation using the C-SSRS

  At 12 months after the intervention

Study Arms (2)

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.

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.

Behavioral: Interventional group : PEPSUI psychoeducational program

Interventions

Interventional group : PEPSUI psychoeducational program BEHAVIORAL

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 : 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

Psychoeducational group

Relaxation group OTHER

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.

Relaxation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• CHU Marius Lacroix, Lille, FRANCE: collaborator
• CHU Gabriel Montpied, Clermont Ferrand, FRANCE: collaborator
• CHU Pasteur, Nice, FRANCE: collaborator
• Centre Psychothérapique de Nancy: collaborator
• CHU Le Vinatier, Bron, FRANCE: collaborator
• CHU Albert Michallon, La Tronche, FRANCE: collaborator
• CHU Tarnier, Paris, FRANCE: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 33884617 DERIVED

• Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

  PMID: 32368793 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Déborah DUCASSE, MD

CONTACT

00 33 4 67 33 82 89; d-ducasse@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: June 14, 2017
• Study Start: September 6, 2017
• Primary Completion: May 6, 2026
• Study Completion: May 6, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)