Mental Health and Well-being of People Who Seek Help From Their Member of Parliament

March 9, 2021 updated by: King's College London
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
662

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • IoPPN, King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People seeking help from their MP over study collection period

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Unable to complete questionnaires on their own/ unaided.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Diagnostic test: 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
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
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR-16/17-3220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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