Suicidal IdeationNCT06686498
Transformative Mixed Evaluation of a Suicide Attempt Recovery Intervention
A study testing Illness Management and Recovery adapted to suicidal behavior (IMR-ACS) in people with Suicidal Ideation and Suicidal Ideation and Behaviors, run by Oriana Arellano Faúndez at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicidal Ideation and Behaviors
- What is being tested?
- Illness Management and Recovery adapted to suicidal behavior (IMR-ACS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 30 Sep 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicidal Ideation, Suicidal Ideation and Behaviors
- Being tested
- Illness Management and Recovery adapted to suicidal behavior (IMR-ACS)
- Keywords
- recovery, reattempters suicide, evaluation, mixed method, intervention, adults
- Medical subject headings
- Suicidal Ideation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illness Management and Recovery adapted to suicidal behavior (IMR-ACS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Illness Management and Recovery adapted to suicidal behavior (IMR-ACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of suicide attempts in the last month
Report clinical team
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment until 6 months after intervention is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start30 Sep 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oriana Arellano Faúndez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oriana Arellano Faúndez, Universidad Católica del Maule
- Investigators
- Pablo I Méndez-Bustos, PhD, Study director, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686498
- Sponsor's protocol ID
- N°78/2024
- Other IDs
- N° 21221222.
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For ethical safeguards, the information that will be shared will be unaggregated and anonymized.
Publications
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.
PubMed 22193671Mueser, 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
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.
PubMed 16899534Mueser 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.
PubMed 12364675Mertens, 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
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.
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.
PubMed 37729121Karadzhov 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.
PubMed 33962518Sokol 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.
PubMed 36384945Espeland 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.
PubMed 35939504
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Recovery Model-based Intervention Targeting Adult Repeat Suicide Attempters: a Transformative Mixed Evaluation
- ClinicalTrials.gov ID
- NCT06686498
- Acronym / sponsor ID
- N°78/2024
- Conditions
- Suicidal Ideation, Suicidal Ideation and Behaviors
- Keywords
- recovery, reattempters suicide, evaluation, mixed method, intervention, adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oriana Arellano FaúndezUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Illness Management and Recovery adapted to suicidal behavior (IMR-ACS)An experimental group called Group B, will receive both the usual treatment (TAU) and the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention and usual treatment |
Primary outcome
Number of suicide attempts in the last month
Time frame: From enrollment until 6 months after intervention is completed
Report clinical team
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 22193671Posner 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.
- BackgroundMueser, 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: PubMed 16899534Mueser 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.
- Background: PubMed 12364675Mueser 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.
- BackgroundMertens, 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
- BackgroundAsociación 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: PubMed 37729121Ropaj 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.
- Background: PubMed 33962518Karadzhov 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.
- Background: PubMed 36384945Sokol 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.
- Background: PubMed 35939504Espeland 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.
- Individual participant dataSharing planned: No. For ethical safeguards, the information that will be shared will be unaggregated and anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo I Méndez-Bustos, PhD study director
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Illness Management and Recovery adapted to suicidal behavior (IMR-ACS) in people with Suicidal Ideation and Suicidal Ideation and Behaviors, run by Oriana Arellano Faúndez at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of suicide attempts in the last month (time frame: From enrollment until 6 months after intervention is completed). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06686498, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.