Transformative Mixed Evaluation of a Suicide Attempt Recovery Intervention

NCT06686498 | Active Not Recruiting

• 2 other identifiers: N°78/2024N° 21221222.
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicidal Ideation and Behaviors

Keywords

recovery; reattempters suicide; evaluation; mixed method; intervention; adults

Outcome Measures

Primary Outcomes (8)

• Number of suicide attempts in the last month

  Report clinical team

  From enrollment until 6 months after intervention is completed

• Severity of Suicidal Ideation

  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

  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

  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

  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

  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

  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

• Socio-structural contextual/

  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

Study Arms (2)

Usual treatment

NO INTERVENTION

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

Intervention and usual treatment

EXPERIMENTAL

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)

Interventions

Illness Management and Recovery adapted to suicidal behavior (IMR-ACS) BEHAVIORAL

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.

Intervention and usual treatment

Eligibility Criteria

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

You may qualify if:

• years of age.
• having made at least two suicide attempts in their lifetime,
• presenting suicidal ideation (active or passive)
• 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

You may not qualify if:

• 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
• to have participated in a group intervention related to mental health issues during the last year.

Sponsors & Collaborators

• Oriana Arellano Faúndez: lead

Study Sites (1)

Hospital Gral. Carlos Ibañez del Campo

Linares, Del Maule, 3580000, Chile

Location

Related Publications (10)

• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

  PMID: 22193671 BACKGROUND

• Mueser, K. (2013). Illness Management and Recovery. SAMSHA´S GAINS Center for Behavioral Health and Justice Transformation https://www.usf.edu/cbcs/mhlp/tac/documents/behavioral-healthcare/samh/illness-management-and-recovery.pdf

  BACKGROUND

• Mueser KT, Meyer PS, Penn DL, Clancy R, Clancy DM, Salyers MP. The Illness Management and Recovery program: rationale, development, and preliminary findings. Schizophr Bull. 2006 Oct;32 Suppl 1(Suppl 1):S32-43. doi: 10.1093/schbul/sbl022. Epub 2006 Aug 9.

  PMID: 16899534 BACKGROUND

• Mueser KT, Corrigan PW, Hilton DW, Tanzman B, Schaub A, Gingerich S, Essock SM, Tarrier N, Morey B, Vogel-Scibilia S, Herz MI. Illness management and recovery: a review of the research. Psychiatr Serv. 2002 Oct;53(10):1272-84. doi: 10.1176/appi.ps.53.10.1272.

  PMID: 12364675 BACKGROUND

• Mertens, D. M. (2021). Transformative research methods to increase social impact for vulnerable groups and cultural minorities. International Journal of Qualitative Methods, 20. https://doi.org/10.1177/16094069211051563

  BACKGROUND

• Asociación Española de Enfermería de Salud Mental (2020). Manejo y Recuperación de un problema de salud mental grave (IMR). Adaptación al español de Substance Abuse and Mental Health Services Administration (2009). Illness Management and Recovery: Practitioner Guides and Handouts. HHS Pub. No. SMA-09-4462, Rockville, MD: Center for Mental Health Services, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services.

  BACKGROUND

• Ropaj E, Haddock G, Pratt D. Developing a consensus of recovery from suicidal ideations and behaviours: A Delphi study with experts by experience. PLoS One. 2023 Sep 20;18(9):e0291377. doi: 10.1371/journal.pone.0291377. eCollection 2023.

  PMID: 37729121 BACKGROUND

• Karadzhov D. Personal recovery and socio-structural disadvantage: A critical conceptual review. Health (London). 2023 Mar;27(2):201-225. doi: 10.1177/13634593211014250. Epub 2021 May 7.

  PMID: 33962518 BACKGROUND

• Sokol Y, Levin C, Linzer M, Rosensweig C, Hubner S, Gromatsky M, Walsh S, Dixon L, Goodman M. Theoretical model of recovery following a suicidal episode (COURAGE): scoping review and narrative synthesis. BJPsych Open. 2022 Nov 17;8(6):e200. doi: 10.1192/bjo.2022.599.

  PMID: 36384945 BACKGROUND

• Espeland K, Loa Knizek B, Hjelmeland H. Lifesaving turning points: First-person accounts of recovery after suicide attempt(s). Death Stud. 2023;47(5):550-558. doi: 10.1080/07481187.2022.2108941. Epub 2022 Aug 8.

  PMID: 35939504 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Behavior

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Study Officials

• Pablo I Méndez-Bustos, PhD

  Universidad Católica del Maule

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: September 30, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)