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About the Genetic Links to Anxiety and Depression (GLAD) Study
The aim of the Genetic Links to Anxiety and Depression (GLAD) Study is to facilitate research investigating both psychological and biological (genetic) risk factors associated with anxiety and depression, and predictors of outcomes. The ultimate goal is to inform better treatment guidelines and improve future care for patients.
The GLAD Study will achieve this aim by recruiting 40,000 people who have experienced depression or anxiety (including bipolar disorder, OCD, and OCD-related disorders) at any point in their lives. We also want to recruit 10,000 individuals without any history of mental disorders to help us explore why some people do and some people don’t become ill. Participants will be a part of the National Institute of Health and Care Research (NIHR) Mental Health BioResource, part of the NIHR BioResource, a re-contactable biobank of phenotypic as well as biological (genetic) data. The biological samples with the linked clinical data provided to the GLAD Study will act as a valuable resource to advance research in mental health and enable discovery.
Participant Recruitment
Individuals aged 16 years or above who have experienced anxiety or depression at any point in their lives (whether that be current or past) or those that have never experienced a mental health disorder will be able to sign up to the study online and become a member. Information about the GLAD Study will be distributed online through a social media campaign or through NHS Trusts and Services. People will be directed to this website to sign-up online.
After participants have registered on the site, they will be able to read through the information sheet, electronically sign the consent form, and complete core psychological screening questionnaires online. This will take approximately 30-60 minutes. They will then receive a saliva kit in the post so that a biological sample can be collected at home and sent back to the lab. Once their kit has been received, participants will be full members of the GLAD Study.
Members of the GLAD Study will have access to useful links and resources available on the website, be able to view ongoing research projects, and can sign up online for studies they are eligible for. They may also be contacted by the GLAD Study or NIHR BioResource teams about future research projects they may want to participate in. If at any point a member decides they do not want to be part of the GLAD Study or the NIHR BioResource, they can withdraw and can ask for their sample and questionnaire data to be destroyed.
Recruiting Sites
Recruiting sites will be involved in the active recruitment of participants to join the GLAD Study. Since the study is designed to be an online resource, involvement and support of the study by NHS Trusts and clinical services can be accomplished at varying levels of involvement. Recruitment methods for GLAD include:
- Advertising and access to data
- Mail-outs (letters, emails, SMS)
- In-person or over-the-phone recruitment of participants
- A local research team assists participants in reading through study information, consenting and completing the questionnaire
Participant Identification Centres (PICs)
Please note that PIC sites do not receive accruals for GLAD.
Advertising Sites
Advertising sites agree to display GLAD Study posters and leaflets in waiting rooms and clinical areas as appropriate. The study team would prefer that all advertising sites also be data sites (see below).
Data Sites
Data sites involve allowing the study team access to medical records. Members of the GLAD Study consent to the study team accessing their medical records, including hospital and GP records. The study team are planning to access clinical data centrally through NHS Digital to avoid burdening individual Trusts and services. If data needs to be collected at individual sites, the exact procedures for how this can be done as well as what funding and support may be needed can be discussed to ensure it is feasible for each site.
Individual sites can decide on their own level of involvement.
GLAD Study Team Responsibilities
The GLAD Study team is available to answer any questions or concerns from NHS sites. The team can be contacted directly at GLADadmin@kcl.ac.uk.
The GLAD Study team will provide training materials to teach local delivery teams about the study protocol and sign-up process. The GLAD team will also schedule phone calls or video conferences to discuss the study and answer any remaining questions.
How to Get Involved
Sites that are interested in getting involved with the GLAD Study, either as a recruiting, data, or advertising site, should contact the GLAD Study team at GLADadmin@kcl.ac.uk to express interest and get added to our waiting list.
Or click below to register and fill out your site’s information:
Once our team has the capacity to launch at your site, we can then begin discussions with your local R&D department regarding the feasibility of launching the GLAD Study and the details of patient recruitment, on-site staff involvement, and linkage with medical records.
Questions?
Please scroll below to find some FAQs we’ve received from sites. If you have other questions that aren’t covered, please email us at GLADadmin@kcl.ac.uk.
Frequently Asked Questions (FAQs)
General FAQs
- How is the study funded?
- The National Institute for Health and Care Research (NIHR) is the primary funder of the GLAD Study.
- What is the study end date?
- Our CRN portfolio eligibility ends on 30th November 2024, so Trusts should use that end date. However, our ethics end date is 09/01/2028 and we plan to renew our portfolio status and our ethics so the study is ongoing. Trust participation can continue as long as there is interest.
- Will study aims and procedures be made clear to participants?
The GLAD Study website, information sheet, consent form, and questionnaire underwent extensive user testing and were revised and checked by the NIHR and mental health charities to make sure they are written in a clear and accessible way.
However, we do understand that some people might still find it difficult to understand, so we have also included a video in the information sheet to explain things more clearly and in a different way. If people are still unsure, we are happy to individually clarify over the phone or by email any questions or doubts they may have.
Participant Eligibility
- What are the eligibility criteria for the study?
Eligibility criteria are as follows. Anyone who meets the below criteria is eligible to take part.
- Have ever experienced or are experiencing anxiety or depressive disorders (including bipolar, OCD, BDD, and OCD-related disorders) with or without a medical diagnosis
- Have never experienced any mental health disorder
- Are 16 or over
- Live in the United Kingdom
- Are there any exclusion criteria?
No. There are no exclusion criteria (beyond individuals who do not meet eligibility criteria or do not have the capacity to consent). However, due to the nature of the study, participants will need access to the Internet and to be proficient in English.
The one potential exception is that we would caution against recruiting patients with comorbid schizophrenia, as often symptoms of anxiety/depression are due to the schizophrenia diagnosis and not distinct disorders. If research teams/clinicians are identifying patients to approach about the study, we would therefore ask not to approach patients with schizophrenia. However, if someone with schizophrenia finds the study on their own and is interested, they are still welcome to sign up.
- Do participants with anxiety and depression need an ‘official’ diagnosis to take part?
- No. Individuals who have experienced anxiety and depression are eligible regardless of diagnosis or treatment. An official diagnosis is therefore not required. For individuals with anxiety and depression without a diagnosis, the sign-up questionnaire screens for eligibility by assessing current/lifetime symptoms of these disorders to provide a “likely” diagnosis.
- Are NHS sites involved in assessing the eligibility of participants based on their responses to the screening questionnaire?
- No. The eligibility of participants will be assessed centrally by the GLAD Study team based on responses to the questionnaire.
- Do participants have to sign up for the study online?
Yes. We cannot offer paper copies of the consent form or the survey. However, sites are welcome to print out the information sheet if there is a local team that will be recruiting.
Individuals who are computer illiterate can receive support in completing the sign-up process from friends, family, or from a local delivery team at participating NHS sites. Furthermore, NHS sites can offer individuals without access to the Internet to come on-site to sign up or recommend that they sign up at their local library.
- Is study information available in other languages?
- Unfortunately not. Many of the questionnaires that we use are only validated in English. As a result, we have written into our protocol that one of the eligibility requirements is to be able to complete the questionnaire in English.
- Can participants refuse consent to data linkage and still be involved in the study?
- No. This is a crucial item in our consent form as the aims of the study directly relate to combined analyses of the clinical, questionnaire, and genetic data.
Recruitment numbers and accruals
- For recruiting sites, is there a minimum site target?
- No. Sites can select their own recruitment targets.
- Are there any methods of recruitment that you recommend?
Sites are free to use a range of recruitment strategies. In addition to our suggestions above, recruitment strategies may include:
- Social media
- Reaching out to local universities or mental health radio stations
- Pairing up with pharmacies: adding leaflets to prescription bags and putting up posters on notice boards
- Advertising the study in staff rooms
Sites are welcome to contact us if they would like to have a further discussion about recruitment strategies, brainstorm ideas or discuss what our top recruiting sites have found to be successful methods.
Please email us at GLADadmin@kcl.ac.uk if you would like to discuss recruitment strategies further or to arrange a call to speak with us.
- How are accruals assigned?
- Accruals will be assigned based on participant completion, eligibility and submission of the questionnaire. At the beginning of the questionnaire, we will ask participants if they heard about our study through an NHS site/service and they will be required to respond yes/no. If they indicate yes, they will then be asked to select their practice or Trust from a dropdown list that will include all active sites (as well as an “other” option, in case).
- What would you recommend to ensure participants know which Trust/NHS site they have been referred from?
- We would recommend adding a sticker to GLAD leaflets/posters with your site name/logo to help participants. If you are doing social media posts or advertising, we would also recommend including the Trust’s name in the post. Local delivery teams approaching participants should always remind participants to indicate on the questionnaire that they found out about the study through your site.
- Who is responsible for uploading accrual/recruitment numbers to CPMS/LPMS?
According to the CRN, the GLAD Study is classed as an exception study, so our central GLAD study team will upload recruitment numbers to CPMS, and these numbers should then be populated into the site’s LPMS (e.g., EDGE). NHS sites will not need to do any uploads to their LPMS.
However, we are often informed that the CPMS uploads are not automatically being transferred to the LPMS. We, therefore, send out monthly updates with our latest recruits to all sites, so that local delivery teams can upload to their LPMS.
- Can sites receive updates on their recruitment numbers?
- Yes, our team sends out monthly updates of recruitment numbers to the staff member(s) of the site’s choosing.
Site Involvement
- Are there any specific requirements for sites to run the study?
- No. We have no requirements to be a site.
- Are NHS local delivery teams sending out the saliva kits or is this done centrally by the study team?
- Typically, kits are sent from the central study team to the participant’s listed address.
- Will NHS sites be involved in future study recontact?
- No. The GLAD Study team is responsible for inviting participants/research teams to collaborate in future research. Any access to data/sample information should be requested through the Manager of the NIHR BioResource Centre Maudsley. Information on how to submit a data/sample access request is in development and will be available on the website once prepared.
Site Set-up/Steps to launch
- Do you require confirmation of capacity?
- For recruiting sites: Yes.
For PIC sites: No. - Do you require a delegation log to be completed for this study?
- No. Sites are welcome to use one internally if helpful.
- Do you require any trust CVs/GCPs for your files?
- No
- Can you create localised versions of the participant information sheet/consent form?
- The PIS and consent form are administered to participants online through the website. We can create a localised version of the PIS for sites to print out to give to participants, but please note that the consent form must be administered online. However, if sites wish for a localised version of the consent form for site records, we can get that sent to you as well.
- Can you create localised versions of the poster/leaflet?
- We order large batches of posters/leaflets to be professionally printed at a single time, and therefore can’t print localised versions. If sites have stickers with the trust/practice logo, these can be added to the pre-printed versions. Otherwise, we can send sites editable versions of the poster/leaflet which sites are welcome to print locally.
Costs
- Is there any funding available for sites?
- The GLAD Study has been accepted onto the NIHR CRN Portfolio, which provides funding to the sites. However, due to the scale of the study and limitations of funding, we do not typically provide funding for research costs.
- Are there any Excess Treatment Costs (ETCs) associated with this study?
- No
Medical records
- How will you link to medical records?
- Accessing medical records is likely to be done centrally, and we will only access relevant sections of our participants’ medical records that will be helpful to our research. In some cases, we might require help from specific NHS trusts or local delivery teams. If we need to access medical records through sites, then we will collaborate with each site individually to find a way to do so which is feasible and can discuss support/funding requirements if needed.
- How are you planning to use medical records?
- We would combine this information with questionnaire data and DNA to provide a comprehensive overview to be used in a wide range of investigations looking into mental health disorders (e.g. risk factors, comorbidities) and treatment outcomes.