- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203966
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
-
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London, United Kingdom, SE5 8AF
- IoPPN, King's College London
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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
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 |
Intervention / Treatment |
---|---|
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
|
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
|
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
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
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
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)
September 24, 2018
Primary Completion (ACTUAL)
September 18, 2019
Study Completion (ACTUAL)
September 18, 2019
Study Registration Dates
First Submitted
December 10, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (ACTUAL)
December 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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