Suicide, AttemptedMSMNCT04796116
Male Suicide and Metacognition
An observational study of Suicide, Attempted, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Suicide is the act of killing oneself and accounts for one death every 40 seconds around the world. In the UK, over 75% of suicides are completed by men. Suicidal ideation is a symptom of depression and is assessed when diagnosing depressive disorder. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Suicide, Attempted
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males aged 16+ who are receiving care from the Home Based Treatment Team following suicidal ideation or behaviour and have capacity to provide informed consent to take part.
Who may be able to join
- Men aged 16+ who are currently receiving care from the Home Based Treatment Team and are experiencing suicidal thoughts and behaviours
- Men with a primary mental health diagnosis of anxiety, depression, acute stress reaction or adjustment disorder, or men with no diagnosis at all
- Men who are able to provide written, informed consent
Who cannot join
- Women will not be eligible as the aim of this study is to investigate masculinity and its impact on suicidality and help-seeking
- Diagnosis of a severe and enduring mental illness such as Schizophrenia or Bipolar Affective Disorder will be excluded, as their suicidality may be secondary to their diagnosis and more suitable to research within that context
- Non-English-speaking as interviews and assessments will be completed in the English language and are not validated in other languages.
- Unable to provide written, informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M2553BL
Sarah Leo, 01612710084, researchoffice@gmmh.nhs.uk
About this study
Official title: An Exploration of the Role of Metacognition and Masculinity in Men Experiencing Suicidality
Suicide is the act of killing oneself and accounts for one death every 40 seconds around the world. In the UK, over 75% of suicides are completed by men. Suicidal ideation is a symptom of depression and is assessed when diagnosing depressive disorder. Men are three times more likely to complete suicide than women but half as likely to be diagnosed with depression, and therefore risk missing out on potentially lifesaving treatments.
Men experiencing depression and associated suicidality are less likely to demonstrate traditional symptoms such as hopelessness and sadness, and more likely to engage in unhelpful coping strategies such as avoidance through over-working, substance misuse, or risk-taking behaviours, and may feel that they have lost control. Previous research has shown a link between rumination and increased suicidal intent.
Read more
Unhelpful coping strategies, distorted beliefs about uncontrollability, and thinking processes such as rumination, are central to the metacognitive model of psychological distress and are targeted in Metacognitive Therapy (MCT).
The aim of this project is to identify if any aspects of the thinking styles described above are present in a sample of men who are suicidal. The project will also explore beliefs about masculinity and how these beliefs might impact help-seeking.
In order to achieve these aims, 15 male service-users without a severe and enduring mental illness, who are receiving care from the Home Based Treatment Team following suicidal thoughts or actions, will be invited to take complete some questionnaires and partake in an interview.
Read the detailed description
The reduction of suicide is a priority for the Department of Health and Social Care which recommends focusing research and interventions on high-risk groups, such as men. 75% of suicides in the UK are completed by men, it is the biggest killer of men under 45, and 12 men die by suicide each day.
Previous research shows that men may be more likely to mask their symptoms and avoid seeking help from friends, family and professionals. Literature suggests this could be due to the social stigma attached to mental ill health and society's traditional expectations of how men should behave. Evidence also suggests that men may be less likely to present with typical symptoms of depression, such as sadness or hopelessness, and be more likely to engage in activities like overworking, substance misuse, promiscuity and gambling. Studies exploring suicidality in adults have found that increased rumination is linked with higher suicidal intent, and that men in particular may experience accepting antidepressant medication as proof that they have 'lost control'.
Rumination, avoidance, maladaptive coping strategies, and beliefs about uncontrollability are known as 'metacognitions' and are targeted in Metacognitive Therapy (MCT). MCT has a growing evidence base for a range of psychological disorders, including anxiety and depression, and aims to reduce rumination, avoidance, worry, and maladaptive coping strategies, whilst supporting the individual to discover control.
There is a lack of research into how the thinking processes described above present in men who are at risk of suicide. This project aims to contribute to this knowledge base in order to discover whether Metacognitive Therapy (or brief metacognitive interventions) may be a viable treatment option for this population, and worthy of further research. This aim will be achieve by determining which, if any, metacognitions are present in a population of men who are suicidal.
Additionally, the project seeks to explore men's beliefs about masculinity and suicide; and how these beliefs along with the thinking styles previously described, may impact on help-seeking. This could inform future planning of engagement and interventions for this population.
Justification for this research can be found in national reports such as 'The Five Year Forward View' and the 'NHS Long Term Plan', both of which highlight suicide prevention, particularly in high-risk groups such as men, as a priority for clinicians and researchers; more locally, Greater Manchester Mental Health's NHS Foundation Trust's 'Research \& Innovation Strategy' commits to conducting research into suicide prevention and improving patient safety.
- Conditions
- Suicide, Attempted
- Medical subject headings
- Suicide, Attempted
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Attentional Syndrome Scale (CAS-1)
Self-report questionnaire, measuring time spent engaging in metacognitive strategies and conviction in metacognitive beliefs. E.g. First section asks individuals how much time they have spent 'dwelling' on their problems on a scale of 0-8, 0 being none of the time and 8 being all of the time. The latter section asks people to rate beliefs about worry, e.g. 'worrying too much could harm me', on a scale of 0-100 ('0' meaning, 'I do not believe this at all' and '100' meaning, 'I am completely convinced this is true'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Measured: 2 minutes
Metacognitions Questionnaire - 30 (MCQ-30)
A self-report questionnaire designed to measure an individual's metacognitive beliefs. The individual rates their agreement with statements such as, 'my worrying is dangerous for me', on a scale of 1-4, 1 meaning 'do not agree' and 4 meaning, 'agree very much'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Measured: 5 minutes
Cognitions Concerning Suicide Scale (CCSS)
Self-report questionnaire, where individuals rate how much they agree with beliefs about suicide, such as, 'everyone has the right to commit suicide'; individuals tick whether they 'strongly disagree, disagree, neutral, agree, or strongly agree'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Measured: 5 minutes
Masculine Behaviour Scale (MBS)
Self-report questionnaire exploring beliefs about masculinity. Individuals rate their agreement with statements about masculinity, such as, 'I don't usually discuss my feelings or emotions with others' by ticking, 'agree, slightly agree, neither agree nor disagree, slightly disagree, disagree'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Measured: 1 minute
Qualitative Interview
Interview conducted using the Metacognitive Profiling Interview Schedule
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonothan Orson, Greater Manchester Mental Health NHS Foundation Trust
- Investigators
- Jonothan Orson, MA Nursing, Principal investigator, Greater Manchester Mental Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796116
- Sponsor's protocol ID
- F485s
- Acronym
- MSM
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared. Records will be accessed by the Principal Investigator and other regulatory bodies only for the purpose of audit or investigation.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Role of Metacognition and Masculinity in Men Experiencing Suicidality
- ClinicalTrials.gov ID
- NCT04796116
- Acronym / sponsor ID
- MSM / F485s
- Conditions
- Suicide, Attempted
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 Mar 2021 (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.
Suicide is the act of killing oneself and accounts for one death every 40 seconds around the world. In the UK, over 75% of suicides are completed by men. Suicidal ideation is a symptom of depression and is assessed when diagnosing depressive disorder. Men are three times more likely to complete suicide than women but half as likely to be diagnosed with depression, and therefore risk missing out on potentially lifesaving treatments.
Men experiencing depression and associated suicidality are less likely to demonstrate traditional symptoms such as hopelessness and sadness, and more likely to engage in unhelpful coping strategies such as avoidance through over-working, substance misuse, or risk-taking behaviours, and may feel that they have lost control. Previous research has shown a link between rumination and increased suicidal intent.
Unhelpful coping strategies, distorted beliefs about uncontrollability, and thinking processes such as rumination, are central to the metacognitive model of psychological distress and are targeted in Metacognitive Therapy (MCT).
The aim of this project is to identify if any aspects of the thinking styles described above are present in a sample of men who are suicidal. The project will also explore beliefs about masculinity and how these beliefs might impact help-seeking.
In order to achieve these aims, 15 male service-users without a severe and enduring mental illness, who are receiving care from the Home Based Treatment Team following suicidal thoughts or actions, will be invited to take complete some questionnaires and partake in an interview.
Detailed description
The reduction of suicide is a priority for the Department of Health and Social Care which recommends focusing research and interventions on high-risk groups, such as men. 75% of suicides in the UK are completed by men, it is the biggest killer of men under 45, and 12 men die by suicide each day.
Previous research shows that men may be more likely to mask their symptoms and avoid seeking help from friends, family and professionals. Literature suggests this could be due to the social stigma attached to mental ill health and society's traditional expectations of how men should behave. Evidence also suggests that men may be less likely to present with typical symptoms of depression, such as sadness or hopelessness, and be more likely to engage in activities like overworking, substance misuse, promiscuity and gambling. Studies exploring suicidality in adults have found that increased rumination is linked with higher suicidal intent, and that men in particular may experience accepting antidepressant medication as proof that they have 'lost control'.
Rumination, avoidance, maladaptive coping strategies, and beliefs about uncontrollability are known as 'metacognitions' and are targeted in Metacognitive Therapy (MCT). MCT has a growing evidence base for a range of psychological disorders, including anxiety and depression, and aims to reduce rumination, avoidance, worry, and maladaptive coping strategies, whilst supporting the individual to discover control.
There is a lack of research into how the thinking processes described above present in men who are at risk of suicide. This project aims to contribute to this knowledge base in order to discover whether Metacognitive Therapy (or brief metacognitive interventions) may be a viable treatment option for this population, and worthy of further research. This aim will be achieve by determining which, if any, metacognitions are present in a population of men who are suicidal.
Additionally, the project seeks to explore men's beliefs about masculinity and suicide; and how these beliefs along with the thinking styles previously described, may impact on help-seeking. This could inform future planning of engagement and interventions for this population.
Justification for this research can be found in national reports such as 'The Five Year Forward View' and the 'NHS Long Term Plan', both of which highlight suicide prevention, particularly in high-risk groups such as men, as a priority for clinicians and researchers; more locally, Greater Manchester Mental Health's NHS Foundation Trust's 'Research \& Innovation Strategy' commits to conducting research into suicide prevention and improving patient safety.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males aged 16+ who are receiving care from the Home Based Treatment Team following suicidal ideation or behaviour and have capacity to provide informed consent to take part.
Key inclusion criteria (3 listed)
- Men aged 16+ who are currently receiving care from the Home Based Treatment Team and are experiencing suicidal thoughts and behaviours
- Men with a primary mental health diagnosis of anxiety, depression, acute stress reaction or adjustment disorder, or men with no diagnosis at all
- Men who are able to provide written, informed consent
Key exclusion criteria (4 listed)
- Women will not be eligible as the aim of this study is to investigate masculinity and its impact on suicidality and help-seeking
- Diagnosis of a severe and enduring mental illness such as Schizophrenia or Bipolar Affective Disorder will be excluded, as their suicidality may be secondary to their diagnosis and more suitable to research within that context
- Non-English-speaking as interviews and assessments will be completed in the English language and are not validated in other languages.
- Unable to provide written, informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Attentional Syndrome Scale (CAS-1)
Time frame: 2 minutes
Self-report questionnaire, measuring time spent engaging in metacognitive strategies and conviction in metacognitive beliefs. E.g. First section asks individuals how much time they have spent 'dwelling' on their problems on a scale of 0-8, 0 being none of the time and 8 being all of the time. The latter section asks people to rate beliefs about worry, e.g. 'worrying too much could harm me', on a scale of 0-100 ('0' meaning, 'I do not believe this at all' and '100' meaning, 'I am completely convinced this is true'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Metacognitions Questionnaire - 30 (MCQ-30)
Time frame: 5 minutes
A self-report questionnaire designed to measure an individual's metacognitive beliefs. The individual rates their agreement with statements such as, 'my worrying is dangerous for me', on a scale of 1-4, 1 meaning 'do not agree' and 4 meaning, 'agree very much'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Cognitions Concerning Suicide Scale (CCSS)
Time frame: 5 minutes
Self-report questionnaire, where individuals rate how much they agree with beliefs about suicide, such as, 'everyone has the right to commit suicide'; individuals tick whether they 'strongly disagree, disagree, neutral, agree, or strongly agree'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Masculine Behaviour Scale (MBS)
Time frame: 1 minute
Self-report questionnaire exploring beliefs about masculinity. Individuals rate their agreement with statements about masculinity, such as, 'I don't usually discuss my feelings or emotions with others' by ticking, 'agree, slightly agree, neither agree nor disagree, slightly disagree, disagree'. There is no 'better' or 'worse' outcome, measure is simply used to describe the population of participants and any common features of the sample.
Qualitative Interview
Time frame: 45 minutes
Interview conducted using the Metacognitive Profiling Interview Schedule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No. IPD will not be shared. Records will be accessed by the Principal Investigator and other regulatory bodies only for the purpose of audit or investigation.
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Suicide
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.
Jonothan Orson, MA Nursing principal investigator
Greater Manchester Mental Health NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, Attempted, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Mar 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonothan Orson, MA Nursing (07990344790, jonothan.orson@gmmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Attentional Syndrome Scale (CAS-1) (time frame: 2 minutes). The study lists 5 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 12 Mar 2021.