NCT04796116

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 5, 2021

Last Update Submit

March 11, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    1 minute

  • Qualitative Interview

    Interview conducted using the Metacognitive Profiling Interview Schedule

    45 minutes

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Manchester Mental Health NHS Foundation Trust

Manchester, M2553BL, United Kingdom

Location

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Jonothan Orson, MA Nursing

    Greater Manchester Mental Health NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonothan Orson, MA Nursing

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Mental Health Nurse

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 12, 2021

Study Start

April 1, 2021

Primary Completion

August 1, 2021

Study Completion

January 1, 2022

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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.

Locations