Clinical trial NCT06686498: Transformative Mixed Evaluation of a Suicide Attempt Recovery Intervention
Official title: Impact of a Recovery Model-based Intervention Targeting Adult Repeat Suicide Attempters: a Transformative Mixed Evaluation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicidal Ideation and Behaviors
Keywords: recovery
reattempters suicide
evaluation
mixed method
intervention
adults
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In coherence with the recovery model and from a transformative paradigm, to meet the objectives, a mixed research study will be conducted, with a concurrent design constituted by two collection threads "QUAN (quantitative) and QUAL (qualitative)". This design is characterized by collecting, analyzing, and merging quantitative and qualitative data and results simultaneously, opting for one paradigm at the base rather than mixing paradigms.

The longitudinal-type quantitative strand comprises a single-blind Randomized Clinical Trial (RCT) with two arms in parallel, in which two groups are compared: a waiting group that will function as a control group, which will receive its treatment as usual (TAU) called Group A. Furthermore, an experimental group called Group B, will receive both the usual treatment (TAU) and the IMR-ACS intervention. For ethical considerations, Group A will receive the
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the impact of a brief clinical group intervention based on the recovery model aimed at adult repeat suicide attempters attending an outpatient unit belonging to a public hospital in the Maule region, comparing two groups, one experimental and one wait group, considering indicators of clinical recovery (suicidal ideation, repetition of suicide attempt, functional disability, depressive symptoms), life satisfaction, social support, user satisfaction and personal recovery experiences lived by adult repeat suicide attempters.

Detailed description: Suicide is a highly prevalent social and public health problem globally, nationally, and regionally. Globally, between 2000 and 2019, the suicide rate has decreased, except in the Americas, where rates increased by 17%. In Chile, according to World Bank data, the rate for the period 2000 to 2019 was nine deaths per 100,000 population, increasing to 10.3 after the COVID-19 pandemic. At the local level, there was a 51% increase in suicide attempts between 2019 and 2022. Additionally, self-inflicted injuries exhibited a 167% surge between 2018 and 2022, thereby elevating the risk of suicide, Despite this, suicide prevention interventions are characterized by being of an individual nature, based on risk and clinical indicators, and with an unproven impact, with even scarcer evidence on intervention models in suicide attempt repeaters. Although, a suicide attempt is the most critical predictor of lethal reattempts or death, especially in people presenting mood disorders.

Traditionally, both research and intervention on suicidal behavior have been approached mainly from the notion of risk, which has not brought, as in the Chilean case, favorable results in reducing suicide rates. This requires incorporating promotional, alternative, and complementary approaches that not only focus on reducing the variables that lead to suicide but also on the recovery of people after a suicidal episode. A positive life trajectory after a suicide attempt is extremely limited in research despite its advantage in helping to obtain favorable outcomes The recovery model implies a change in the view on mental health intervention, as it recognizes people's strengths and capabilities and transforms their role from that of the patient to that of the citizen. The model is closely related to social justice and places the person at the center.

In the field of suicidal behavior, adopting a recovery model constitutes a relevant strategy for suicide prevention, which does not imply leaving aside models focused on risk factors, but complementing it with an approach that takes into account the person in his or her family, social and cultural context.

Recovering after an attempt involves taking control of one's life and establishing a new daily life. It is a process that can be facilitated and constrained by a socio-structural context and can be referred both to clinical recovery, understood as a change in scores from a clinical to a non-clinical range on a series of measures capturing suicidal ideation and likelihood of suicide attempt, as to personal recovery, understood as a process of reconnecting with oneself while struggling with the death wish, which involves achieving a sense of agency, overcoming stigma, gaining social support, and developing social roles.

The present study aims to evaluate the impact of a recovery-based intervention considering indicators of clinical recovery (suicidal ideation, suicide attempt, functional disability), life satisfaction, user satisfaction, social support, and personal recovery experiences lived by adults' repeaters of suicide attempts, attended in an outpatient mental health center in the Maule region recognizing their socio-structural context.

Based on a transformative paradigm, the "QUAN + QUAL" concurrent mixed design integrates two data collection threads. A quantitative thread characterized by a single-blind randomized clinical trial with two parallel arms and a qualitative thread with a descriptive phenomenological design.

The proposed impact evaluation, by focusing on both clinical and personal recovery and the socio-structural context in which it is framed, allows us to address a notion of impact that recognizes the complex and processual nature of recovery for people with a history of suicide attempts.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age.
2. having made at least two suicide attempts in their lifetime,
3. presenting suicidal ideation (active or passive)
4. receiving individual outpatient treatment for a diagnosis of depression in a specialized mental health center, belonging to a Chilean Public Hospital, with a moderate-severe to severe level according to references from the clinical team

Exclusion Criteria:

1. to present dual pathology, active psychosis, cognitive or physical impairment, or other problems that impede the ability to understand the study procedures and give informed consent
2. to have participated in a group intervention related to mental health issues during the last year.

Primary outcomes:
measure: Number of suicide attempts in the last month
timeFrame: From enrollment until 6 months after intervention is completed
measure: Severity of Suicidal Ideation
timeFrame: From enrollment until 6 months after intervention is completed
measure: Level of Functional Disability
timeFrame: From enrollment until 6 months after intervention is completed
measure: Satisfaction with life
timeFrame: From enrollment until 6 months after intervention is completed
measure: Social Support
timeFrame: From enrollment until 6 months after intervention is completed
measure: User satisfaction
timeFrame: From registration and at the end of the intervention
measure: Depression
timeFrame: From enrollment until 6 months after intervention is completed
measure: Socio-structural contextual/
timeFrame: From enrollment until 6 months after intervention is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Linares
country: Chile
facility: Hospital Gral. Carlos Ibañez del Campo
state: Del Maule
Study officials:
affiliation: Universidad Católica del Maule
name: Pablo I Méndez-Bustos, PhD
role: STUDY_DIRECTOR
References:
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