Transformative Mixed Evaluation of a Suicide Attempt Recovery Intervention

November 12, 2024 updated by: Oriana Arellano Faúndez

Impact of a Recovery Model-based Intervention Targeting Adult Repeat Suicide Attempters: a Transformative Mixed Evaluation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Del Maule
      • Linares, Del Maule, Chile, 3580000
        • Hospital Gral. Carlos Ibañez del Campo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual treatment
A waiting group that will function as a control group, which will receive its treatment as usual (TAU) called Group A. For ethical considerations, Group A will receive intervention once its impact has been proven through the present study
Experimental: Intervention and usual treatment
An experimental group called Group B, will receive both the usual treatment (TAU) and the intervention.
Behavioral: Illness Management and Recovery adapted to suicidal behavior (IMR-ACS)

Illness Management and Recovery adapted to suicidal behavior (IMR-ACS) is a protocolized clinical intervention in a brief group format aimed at people at risk of suicide. Specifically, people who have had more than two attempts in their lifetime are called repeaters. For its construction, we relied on the Spanish version of the Illness Management and Recovery IMR, developed by the Spanish Nursing Association, adapted to the field of suicidal behavior, taking as a reference the model of personal recovery from suicide attempt proposed by Sokol et al.

The goals of IMR-ACS are to 1) know the warning signs of a suicidal crisis, 2) implement strategies to manage the suicidal crisis, 3) foster social support among peers, 4) formulate goals for recovery from a suicidal crisis, and 5) seek help and make informed decisions in the event of a suicidal crisis.

IMR-ACS is a complementary intervention to the usual treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of suicide attempts in the last month
Time Frame: From enrollment until 6 months after intervention is completed
Report clinical team
From enrollment until 6 months after intervention is completed
Socio-structural contextual/
Time Frame: From enrollment until 6 months after intervention is completed
Sociodemographic questionnaire: sex/gender, socioeconomic status, educational level, ethnicity, employment and housing status, etc. Variables measured ordinally, dichotomously, and nominally.
From enrollment until 6 months after intervention is completed
Severity of Suicidal Ideation
Time Frame: From enrollment until 6 months after intervention is completed
Columbia University Assessment of Suicidal Ideation Intensity Scale, C-SSRS Chile/Spanish 5.1 It includes six items with four Likert-type response options. Scoring: Minimum 0 points - Maximum 6 points. A higher score indicates greater severity of suicidal ideation.
From enrollment until 6 months after intervention is completed
Level of Functional Disability
Time Frame: From enrollment until 6 months after intervention is completed

Questionnaire for the Assessment of Functional Disability self-administered version, WHODAS 2.0.

The WHODAS 2.0 is a 12-item questionnaire that assesses six domains of functioning across physical and mental health disorders in clinical and non-clinical populations: cognition, mobility, self-care, getting along, life activities, and participation. Items are scored on a 5-point Likert scale ranging from 1 (None) to 5 (Extreme or cannot do) and are summed to create total and domain scores. Scores: Minimum 12 points - Maximum 60 points. A higher score indicates a higher level of total and domain disability.
From enrollment until 6 months after intervention is completed
Satisfaction with life
Time Frame: From enrollment until 6 months after intervention is completed
Satisfaction with Life Scale. The SWLS, a measure of global cognitive judgments of life satisfaction, will be used to measure life satisfaction. Individuals provide a self-report response to five items on a 7-point Likert scale. Items are summed for a total score that can range from 5 to 35, with increasing scores indicating increased satisfaction with life. The SWLS has demonstrated good reliability and validity.
From enrollment until 6 months after intervention is completed
Social Support
Time Frame: From enrollment until 6 months after intervention is completed
Perceived Social Support Scale, MOS. The scale consists of 19 items with a 5-point Likert-type response format. The first item measures the size of the social network, and the remaining items measure 4 dimensions of perceived social support: positive social interaction, affective, instrumental and emotional/informational support. Scores: Minimum 19 points - Maximum 60 points. A higher score indicates a higher level of social support overall and by dimension.
From enrollment until 6 months after intervention is completed
User satisfaction
Time Frame: From registration and at the end of the intervention
Customer Satisfaction Questionnaire, CSQ-8. It includes eight items with four Likert-type response options. Scores: Minimum 8 points - Maximum 32 points. A higher score indicates a higher level of user satisfaction.
From registration and at the end of the intervention
Depression
Time Frame: From enrollment until 6 months after intervention is completed
Patient Health Questionnaire, PHQ9. The PHQ-9 is a screening scale that measures the presence and severity of depressive symptoms, and consists of 9 items with a 3-point Likert-type response format. Scores: Minimum 0 points - Maximum 27 points. A higher score indicates greater severity of depressive symptoms.
From enrollment until 6 months after intervention is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oriana Arellano Faúndez

Investigators

  • Study Director: Pablo I Méndez-Bustos, PhD, Universidad Católica del Maule

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N°78/2024
  • N° 21221222. (Other Identifier: National Research and Development Agency (ANID))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For ethical safeguards, the information that will be shared will be unaggregated and anonymized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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