Common Mental DisordersNCT04203966
Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
An observational study of Common Mental Disorders and Alcohol Use Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
This is an observational study to assess the prevalence of common mental disorders and alcohol use disorders in a population of individuals seeking help from their Member of Parliament (MP) in the UK. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Mental Disorders, Alcohol Use Disorder
- What is being tested?
- 12-item General Health Questionnaire (GHQ-12) and WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool)
- How many people
- 662 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2018to 18 Sep 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People seeking help from their MP over study collection period
Who may be able to join
- Attending selected MP surgeries (e.g. in Central Suffolk \& North Ipswich)
- Over the age of 18
- Must be able to complete paper or online questionnaires.
- Have consented to take part in the study
Who cannot join
- Unable to complete questionnaires on their own/ unaided.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study to assess the prevalence of common mental disorders and alcohol use disorders in a population of individuals seeking help from their Member of Parliament (MP) in the UK.
Read the detailed description
Members of Parliament (MP) in the United Kingdom (UK) represent the interests of their constituents. Constituents may contact their MP for assistance if they feel that they have been treated unfairly by a government department or agency, have concerns relating to their local area, or are wanting support from their MP for a campaign they are involved in. In order to fulfil their duty to constituents, MPs hold regular surgeries which allow anyone with a concern to meet with them to discuss the issue in question further. Given the role of the MP in representing people who may be in the midst of stressful events, such as a dispute, it is possible that mental health problems may be more prevalent in this population. However, at present MPs are not given any additional training in recognising mental distress, and may not know how to appropriately sign-post people to appropriate supportive services, nor do MPs receive advice in supporting such individuals. To the best of the investigator's knowledge, there have been no prior studies in this area. The findings of this study will inform initiatives to improve MP working practices, to and raise awareness of the mental health challenges faced by their constituents, with the aim of better meeting the mental health needs of constituents who attend MP surgeries in the future.
- Conditions
- Common Mental Disorders, Alcohol Use Disorder
- Being tested
- 12-item General Health Questionnaire (GHQ-12), WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-item General Health Questionnaire (GHQ-12)Diagnostic test
Structured validated screening tools to assess for the presence of CMDs, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them
WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool)Diagnostic test
Structured validated screening tools to assess for the presence of alcohol use disorders, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them
| Study group | Role | What they receive |
|---|---|---|
| Common mental disorders/ versus no common mental disorders | No intervention This is a prevalence study- presence of common mental disorders (CMDs) will be assessed using the 12-item general Health Questionnaire, with responses above validated cut-points taken to indicate presence of CMDs Receives: Diagnostic Test: 12-item General Health Questionnaire (GHQ-12) | |
| Alcohol use disorders/ versus no alcohol use disorders | No intervention This is a prevalence study- presence of alcohol use disorders will be assessed using the World Health Organization (WHO) AUDIT, with responses above validated cutpoints taken to indicate presence of alcohol use disorders Receives: Diagnostic Test: WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of common mental disorders indicated by scores above validated cutpoints on the GHQ-12
The 12-item General Health Questionnaire (GHQ-12) is a structured validated screening tool to assess for the presence of CMDs, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them. We will use validated cut points, individuals scoring above these (for example 4 or more on the GHQ-12) will be determined as having a common mental disorder
Measured: Cross-sectional analysis, data was collected from September 2018, with exposures and outcomes collected at the same time points (ie. when people fill out the questionnaire). Time frame for analysis will be through to study completion.
Secondary outcomes (1)
Presence of alcohol use disorders, indicated by scores above validated cutpoints on the WHO AUDIT tool
The World Health Organization (WHO) AUDIT is a structured validated screening tool to assess for the presence of alcohol use disorders, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them. We will use validated cutpoints to assess for the presence of harmful and hazardous alcohol use disorders.
Measured: Cross-sectional analysis, data was collected from September 2018, with exposures and outcomes collected at the same time points (ie. when people fill out the questionnaire). Time frame for analysis will be through to study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start24 Sep 2018
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Mental DisordersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203966
- Sponsor's protocol ID
- HR-16/17-3220
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
- ClinicalTrials.gov ID
- NCT04203966
- Acronym / sponsor ID
- HR-16/17-3220
- Conditions
- Common Mental Disorders, Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 18 Dec 2019 (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 is an observational study to assess the prevalence of common mental disorders and alcohol use disorders in a population of individuals seeking help from their Member of Parliament (MP) in the UK.
Detailed description
Members of Parliament (MP) in the United Kingdom (UK) represent the interests of their constituents. Constituents may contact their MP for assistance if they feel that they have been treated unfairly by a government department or agency, have concerns relating to their local area, or are wanting support from their MP for a campaign they are involved in. In order to fulfil their duty to constituents, MPs hold regular surgeries which allow anyone with a concern to meet with them to discuss the issue in question further. Given the role of the MP in representing people who may be in the midst of stressful events, such as a dispute, it is possible that mental health problems may be more prevalent in this population. However, at present MPs are not given any additional training in recognising mental distress, and may not know how to appropriately sign-post people to appropriate supportive services, nor do MPs receive advice in supporting such individuals. To the best of the investigator's knowledge, there have been no prior studies in this area. The findings of this study will inform initiatives to improve MP working practices, to and raise awareness of the mental health challenges faced by their constituents, with the aim of better meeting the mental health needs of constituents who attend MP surgeries in the future.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common mental disorders/ versus no common mental disorders | – | Diagnostic Test: 12-item General Health Questionnaire (GHQ-12)No intervention This is a prevalence study- presence of common mental disorders (CMDs) will be assessed using the 12-item general Health Questionnaire, with responses above validated cut-points taken to indicate presence of CMDs |
| Alcohol use disorders/ versus no alcohol use disorders | – | Diagnostic Test: WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool)No intervention This is a prevalence study- presence of alcohol use disorders will be assessed using the World Health Organization (WHO) AUDIT, with responses above validated cutpoints taken to indicate presence of alcohol use disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People seeking help from their MP over study collection period
Key inclusion criteria (4 listed)
- Attending selected MP surgeries (e.g. in Central Suffolk \& North Ipswich)
- Over the age of 18
- Must be able to complete paper or online questionnaires.
- Have consented to take part in the study
Key exclusion criteria (1 listed)
- Unable to complete questionnaires on their own/ unaided.
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 |
|---|---|---|
| 12-item General Health Questionnaire (GHQ-12)Structured validated screening tools to assess for the presence of CMDs, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them | Diagnostic test | Common mental disorders/ versus no common mental disorders |
| WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool)Structured validated screening tools to assess for the presence of alcohol use disorders, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them | Diagnostic test | Alcohol use disorders/ versus no alcohol use disorders |
Primary outcome
Presence of common mental disorders indicated by scores above validated cutpoints on the GHQ-12
Time frame: Cross-sectional analysis, data was collected from September 2018, with exposures and outcomes collected at the same time points (ie. when people fill out the questionnaire). Time frame for analysis will be through to study completion.
The 12-item General Health Questionnaire (GHQ-12) is a structured validated screening tool to assess for the presence of CMDs, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them. We will use validated cut points, individuals scoring above these (for example 4 or more on the GHQ-12) will be determined as having a common mental disorder
1 secondary outcome
Presence of alcohol use disorders, indicated by scores above validated cutpoints on the WHO AUDIT tool
Time frame: Cross-sectional analysis, data was collected from September 2018, with exposures and outcomes collected at the same time points (ie. when people fill out the questionnaire). Time frame for analysis will be through to study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Common Mental Disorders and Alcohol Use Disorder, run by King's College London 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of common mental disorders indicated by scores above validated cutpoints on the GHQ-12 (time frame: Cross-sectional analysis, data was collected from September 2018, with exposures and outcomes collected at the same time points (ie. when people fill out the questionnaire). Time frame for analysis will be through to study completion.). 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 11 Mar 2021.