NCT04203966

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
662

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
Last Updated

March 11, 2021

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

December 10, 2019

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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.

Study Arms (2)

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)

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)

Interventions

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

Common mental disorders/ versus no common mental 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

Alcohol use disorders/ versus no alcohol use disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People seeking help from their MP over study collection period

You may qualify if:

  • 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

You may not qualify if:

  • \- Unable to complete questionnaires on their own/ unaided.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IoPPN, King's College London

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 18, 2019

Study Start

September 24, 2018

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

March 11, 2021

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations