Persons With High Suicide Ideation or AttemptsNCT06652815
Cognition, Metacognition, and Stigma in Patients With Suicidal Ideation
An observational study of Persons With High Suicide Ideation or Attempts, run by University of Pittsburgh.
Trial summary
Deficits of executive function, meta cognition and stigma is known in suicidal ideation; however, their relationship is unknown. Since many studies use a single indicator of executive function and, it was considered important to study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Persons With High Suicide Ideation or Attempts
- What is being tested?
- Suicide ideation or suicide attempt
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 31 Dec 2028
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The present study is a cross sectional study. For the purpose of this study, individuals with suicidal ideation and attempts who are seeking treatment at the outpatient department of Psychiatry, as well as medical emergency of Dr. RML Hospital or referred to Department of Clinical Psychology would be approached to participate in the study.
Who may be able to join
- Any gender
- Age between 18 to 60 years.
- Able to read and write in Hindi and English
- With a primary mental health diagnosis of anxiety, depression, acute stress reaction or adjustment disorder, or with no diagnosis at all
- Persons with high suicidal ideation (Score 2 or more in first five items of BSSI)
- Person who attempted suicide in last three months.
Who cannot join
- Any comorbid personality disorder diagnosis
- Diagnosis of a major mental disorder such as Schizophrenia or Bipolar Affective Disorder.
- Intellectual Disability and neurological disorder.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Deficits of executive function, meta cognition and stigma is known in suicidal ideation; however, their relationship is unknown. Since many studies use a single indicator of executive function and, it was considered important to study. Metacognition, executive functioning and stigma are the possible driving force behind the suicidal behavior in human being. With respect to research in the Indian context, there is paucity of studies exploring these factors. The purpose of the present study is to explore the relationships between executive functioning, metacognition, and stigma in suicidal ideation and suicide attempters in the Indian setup, where there is a lacuna in research regarding the same. Having a detailed understanding of these psychological parameters will be helpful in suicide prevention and management.
Read the detailed description
Worldwide 10 to 20 million individuals attempt suicide every year. The suicide rate in India is 10.3. In the last three decades, the suicide rate has increased by 43% but the male female ratio has been stable at 1.4: 1. Majority (71%) of suicide in India are by persons below the age of 44 years which imposes a huge social, emotional and economic burden. Those having suicide ideas, about one third of them act with a suicide attempt, and 60% of these transitions occur within the first year after onset of suicidal thoughts.
Executive functioning and Suicide Studies reported that deficits in some executive functions are correlated with an elevated risk for suicide attempts. Executive dysfunction may interfere with an individual's ability to understand that they are at risk for suicide as well as with their ability to cope with that risk. Although past studies have identified the role of cognitive factors in suicide, little has been done to explore the cognitive processes involved in suicidal thinking in adults (Ong et al. 2016). Neuropsychological alterations can lead to inaccurate perception, interpretation, and response to environmental information, which could be a risk factor for suicide (Fernández-Sevillano et al. 2021).
Metacognition is an essential process regarding decision making and coping with stressful life events. It describes the awareness of person's cognitions in relation to suicide (thoughts, beliefs and attributions). The suicidal person feels helpless and decides that death is only solution. The person has narrowed all his/her options solely to death. Knowing these patterns will give some guidance in talking to a suicidal person. It is significant for assessing to try to accept and understand feelings "meta-emotion" and thought/attributions "meta-cognition" the person is expressing (Abdulla et al. 2018).
Stigma is most often defined as a mark of disgrace or infamy; a stain or reproach, as on one's reputation. In suicide investigators talk about public and self-stigma. Both forms of stigma can separately cause social isolation, demoralization, hopelessness and other consequences that interfere with the previous functioning. Because of the high incidence of psychological changes after stigma it is crucial for the bereaved to have close mental health services. But stigma is a barrier to treatment seeking. After suicide attempt most survivors feel stigmatized but it is not yet known which factors modify the perception of stigma (Sabina et al. 2017).
The purpose of the present study is to explore the relationships between executive functioning metacognition, and stigma in suicidal ideation and suicide attempters in the Indian setup, where there is a lacuna in research regarding the same.
Research questions
- What is the executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts?
- Is there any relationship among executive functioning, metacognitive beliefs, and stigma in these individuals? Hypotheses There will be a relationship among executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts.
Objective To assess the executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts.
To study the relationship among executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts.
Methodology Samples size: Total number of sample for this study will be N=212. The sample size 212 was calculated on the basis of estimated population of 1000 using Epitools online sample size calculator (https://epitools.ausvet.com.au/oneproportion) , and Confidence level was 0.95, with Desired precision of estimate=0.05.
Sampling: Probability sampling (Simple random sampling (Every Individual with high suicide ideation or suicide attempts visiting to ABVIMS -Dr. RML Hospital for treatment will be screened for this study.
The present study is a cross sectional study. For the purpose of this study, individuals with suicidal ideation and attempts who are seeking treatment at the outpatient department of Psychiatry, as well as medical emergency of Dr. RML Hospital or referred to Department of Clinical Psychology would be approached to participate in the study.
After establishing the rapport, diagnostic clarifications (ICD-10) and screening for high suicide ideation using Beck Scale for Suicidal Ideation (BSSI), inclusion and exclusion criteria will be applied. Participant who fulfils inclusion criteria will be introduced to the study details, then they will be explained about the purpose of the study and its associated aspects and informed consent will be taken. Their socio- demographics details will also be gathered. Following this Depression, Anxiety and Stress Scale (DASS-21), Wisconsin Card Sorting Test (WCST), Metacognitions Scale (MCQ-30) and Stigma of Suicide Scale (SOSS) will be administered.
All the data will be kept confidential in lock and key and using password protected files. Once all the assessment will be completed data entry in excel sheets will be done and analysis of the data will be done using appropriate SPSS statistical package. After all the analysis completed result and discussion of the study will be prepared.
Detail of tools to be used:
- ICD-10 Research diagnostic criteria
- Socio-demographic and clinical data sheet
- Depression, Anxiety and Stress Scale-21 Items (DASS-21)
- Beck Scale for Suicidal Ideation (BSSI)
- Wisconsin Card Sorting Test (WCST)
- Metacognitions Scale (MCQ-3)
- Stigma of Suicide Scale (SOSS)
- Being tested
- Suicide ideation or suicide attempt
- Keywords
- Suicide attempt, Metacognition, suicide ideation, Executive function
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide ideation or suicide attemptBehavioural
Individuals with high suicide ideation or suicide attempts visiting ABVIMS -Dr. RML Hospital for treatment will be screened for this study. socio- demographics details will also be gathered. Following this Depression, Anxiety and Stress Scale (DASS-21), Wisconsin Card Sorting Test (WCST), Metacognitions Scale (MCQ-30) and Stigma of Suicide Scale (SOSS) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Persons with suicide attempt or suicide ideation | Individuals with high suicide ideation or suicide attempts visiting ABVIMS -Dr. RML Hospital for treatment will be screened for this study. Receives: Behavioral: Suicide ideation or suicide attempt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacognition measured by Metacognitions Questionnaire (MCQ-3) scores
The Metacognitions Questionnaire-30 (MCQ-30) is a self-report measure that assesses metacognitive beliefs. The MCQ-30 is comprised of five factors. Responses are required on a four-point scale ranging from 1 (do not agree) to 4 (agree very much), high scores reflect more reported problems with the item in question.
Measured: Within one week
Depression, Anxiety and Stress Scale-21 scores
Depression, Anxiety and Stress Scale-21 Items (DASS-21): The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Higher scores mean more anxiety or depression and low scores means low anxiety or depression.
Measured: Within one week
Stigma of Suicide Scale (SOSS) scores
The Stigma of Suicide Scale is designed to assess stigmatizing attitudes of general community members toward people who suicide. The short form consists of 16 items. Each item consists of a one-word descriptor of a person who dies by suicide. We will use the short form. Each item is to be rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree. Higher scores indicate higher levels of stigma towards people who suicide.
Measured: Within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jun 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persons With High Suicide Ideation or AttemptsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD, PhD, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652815
- Sponsor's protocol ID
- STUDY23010161
- Other IDs
- D43TW009114
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial as well as protocol will be shared on request at 1-2 years after article publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition, Metacognition, and Stigma in Patients With Suicidal Ideation
- ClinicalTrials.gov ID
- NCT06652815
- Acronym / sponsor ID
- STUDY23010161
- Keywords
- Suicide attempt, Metacognition, suicide ideation, Executive function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Oct 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.
Deficits of executive function, meta cognition and stigma is known in suicidal ideation; however, their relationship is unknown. Since many studies use a single indicator of executive function and, it was considered important to study. Metacognition, executive functioning and stigma are the possible driving force behind the suicidal behavior in human being. With respect to research in the Indian context, there is paucity of studies exploring these factors. The purpose of the present study is to explore the relationships between executive functioning, metacognition, and stigma in suicidal ideation and suicide attempters in the Indian setup, where there is a lacuna in research regarding the same. Having a detailed understanding of these psychological parameters will be helpful in suicide prevention and management.
Detailed description
Worldwide 10 to 20 million individuals attempt suicide every year. The suicide rate in India is 10.3. In the last three decades, the suicide rate has increased by 43% but the male female ratio has been stable at 1.4: 1. Majority (71%) of suicide in India are by persons below the age of 44 years which imposes a huge social, emotional and economic burden. Those having suicide ideas, about one third of them act with a suicide attempt, and 60% of these transitions occur within the first year after onset of suicidal thoughts.
Executive functioning and Suicide Studies reported that deficits in some executive functions are correlated with an elevated risk for suicide attempts. Executive dysfunction may interfere with an individual's ability to understand that they are at risk for suicide as well as with their ability to cope with that risk. Although past studies have identified the role of cognitive factors in suicide, little has been done to explore the cognitive processes involved in suicidal thinking in adults (Ong et al. 2016). Neuropsychological alterations can lead to inaccurate perception, interpretation, and response to environmental information, which could be a risk factor for suicide (Fernández-Sevillano et al. 2021).
Metacognition is an essential process regarding decision making and coping with stressful life events. It describes the awareness of person's cognitions in relation to suicide (thoughts, beliefs and attributions). The suicidal person feels helpless and decides that death is only solution. The person has narrowed all his/her options solely to death. Knowing these patterns will give some guidance in talking to a suicidal person. It is significant for assessing to try to accept and understand feelings "meta-emotion" and thought/attributions "meta-cognition" the person is expressing (Abdulla et al. 2018).
Stigma is most often defined as a mark of disgrace or infamy; a stain or reproach, as on one's reputation. In suicide investigators talk about public and self-stigma. Both forms of stigma can separately cause social isolation, demoralization, hopelessness and other consequences that interfere with the previous functioning. Because of the high incidence of psychological changes after stigma it is crucial for the bereaved to have close mental health services. But stigma is a barrier to treatment seeking. After suicide attempt most survivors feel stigmatized but it is not yet known which factors modify the perception of stigma (Sabina et al. 2017).
The purpose of the present study is to explore the relationships between executive functioning metacognition, and stigma in suicidal ideation and suicide attempters in the Indian setup, where there is a lacuna in research regarding the same.
Research questions
- What is the executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts?
- Is there any relationship among executive functioning, metacognitive beliefs, and stigma in these individuals? Hypotheses There will be a relationship among executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts.
Objective To assess the executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts.
To study the relationship among executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts.
Methodology Samples size: Total number of sample for this study will be N=212. The sample size 212 was calculated on the basis of estimated population of 1000 using Epitools online sample size calculator (https://epitools.ausvet.com.au/oneproportion) , and Confidence level was 0.95, with Desired precision of estimate=0.05.
Sampling: Probability sampling (Simple random sampling (Every Individual with high suicide ideation or suicide attempts visiting to ABVIMS -Dr. RML Hospital for treatment will be screened for this study.
The present study is a cross sectional study. For the purpose of this study, individuals with suicidal ideation and attempts who are seeking treatment at the outpatient department of Psychiatry, as well as medical emergency of Dr. RML Hospital or referred to Department of Clinical Psychology would be approached to participate in the study.
After establishing the rapport, diagnostic clarifications (ICD-10) and screening for high suicide ideation using Beck Scale for Suicidal Ideation (BSSI), inclusion and exclusion criteria will be applied. Participant who fulfils inclusion criteria will be introduced to the study details, then they will be explained about the purpose of the study and its associated aspects and informed consent will be taken. Their socio- demographics details will also be gathered. Following this Depression, Anxiety and Stress Scale (DASS-21), Wisconsin Card Sorting Test (WCST), Metacognitions Scale (MCQ-30) and Stigma of Suicide Scale (SOSS) will be administered.
All the data will be kept confidential in lock and key and using password protected files. Once all the assessment will be completed data entry in excel sheets will be done and analysis of the data will be done using appropriate SPSS statistical package. After all the analysis completed result and discussion of the study will be prepared.
Detail of tools to be used:
- ICD-10 Research diagnostic criteria
- Socio-demographic and clinical data sheet
- Depression, Anxiety and Stress Scale-21 Items (DASS-21)
- Beck Scale for Suicidal Ideation (BSSI)
- Wisconsin Card Sorting Test (WCST)
- Metacognitions Scale (MCQ-3)
- Stigma of Suicide Scale (SOSS)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with suicide attempt or suicide ideation | – | Behavioral: Suicide ideation or suicide attemptIndividuals with high suicide ideation or suicide attempts visiting ABVIMS -Dr. RML Hospital for treatment will be screened for this study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The present study is a cross sectional study. For the purpose of this study, individuals with suicidal ideation and attempts who are seeking treatment at the outpatient department of Psychiatry, as well as medical emergency of Dr. RML Hospital or referred to Department of Clinical Psychology would be approached to participate in the study.
Key inclusion criteria (6 listed)
- Any gender
- Age between 18 to 60 years.
- Able to read and write in Hindi and English
- With a primary mental health diagnosis of anxiety, depression, acute stress reaction or adjustment disorder, or with no diagnosis at all
- Persons with high suicidal ideation (Score 2 or more in first five items of BSSI)
Key exclusion criteria (3 listed)
- Any comorbid personality disorder diagnosis
- Diagnosis of a major mental disorder such as Schizophrenia or Bipolar Affective Disorder.
- Intellectual Disability and neurological disorder.
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 |
|---|---|---|
| Suicide ideation or suicide attemptIndividuals with high suicide ideation or suicide attempts visiting ABVIMS -Dr. RML Hospital for treatment will be screened for this study. socio- demographics details will also be gathered. Following this Depression, Anxiety and Stress Scale (DASS-21), Wisconsin Card Sorting Test (WCST), Metacognitions Scale (MCQ-30) and Stigma of Suicide Scale (SOSS) will be administered. | Behavioural | Persons with suicide attempt or suicide ideation |
Primary outcome
Metacognition measured by Metacognitions Questionnaire (MCQ-3) scores
Time frame: Within one week
The Metacognitions Questionnaire-30 (MCQ-30) is a self-report measure that assesses metacognitive beliefs. The MCQ-30 is comprised of five factors. Responses are required on a four-point scale ranging from 1 (do not agree) to 4 (agree very much), high scores reflect more reported problems with the item in question.
Depression, Anxiety and Stress Scale-21 scores
Time frame: Within one week
Depression, Anxiety and Stress Scale-21 Items (DASS-21): The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Higher scores mean more anxiety or depression and low scores means low anxiety or depression.
Stigma of Suicide Scale (SOSS) scores
Time frame: Within one week
The Stigma of Suicide Scale is designed to assess stigmatizing attitudes of general community members toward people who suicide. The short form consists of 16 items. Each item consists of a one-word descriptor of a person who dies by suicide. We will use the short form. Each item is to be rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree. Higher scores indicate higher levels of stigma towards people who suicide.
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 16 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial as well as protocol will be shared on request at 1-2 years after article publication.
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.
Vishwajit L Nimgaonkar, MD, PhD principal investigator
University of Pittburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Persons With High Suicide Ideation or Attempts, run by University of Pittsburgh.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Triptish Bhatia, PhD (09910107210, bhatiatriptish@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metacognition measured by Metacognitions Questionnaire (MCQ-3) scores (time frame: Within one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.