To view this information in PDF format, please download the site information sheet by clicking the button below. Please note that the FAQs at the bottom of this page are not included in the PDF document.

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 to join the National Institute of Health Research (NIHR) Mental Health 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 that have experienced anxiety or depression at any point in their lives (whether that be current or past) 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 patients have registered to the site, they will be able to read through the information sheet, electronically sign the consent form, and complete core psychological screening questionnaires online. 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, patients will be full members of the GLAD Study.

Members of the GLAD Study will have access to useful links and resources available to the website, be able to view ongoing research projects, and can sign up online to 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.

NHS Involvement

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 access to 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.

Recruiting Sites

Recruiting sites will be involved in active recruitment of patients 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 which assists patients in reading through study information, consenting, completing the questionnaire, and perhaps also in providing a saliva sample

Individual sites can decide on their own level of involvement.

Improving Access to Psychological Therapies (IAPT) Services

The GLAD Study is also recruiting through IAPT services and has specific recruitment procedures tailored for IAPT. If your trust has an IAPT site, please let us know and we can share more information about IAPT recruitment methods for GLAD. Please note that recruitment for GLAD is not limited to IAPT services, and trusts can use more than one method or site of recruitment. Trusts with IAPT services can also recruit through other clinics.

For more information, please click the button below to download the IAPT site information sheet.

GLAD Study Team Responsibilities

The GLAD Study team are also available to answer any patient questions or concerns, therefore all patients who want more information can be directed to contact the GLAD Study team directly. Our contact details are available on this website at www.gladstudy.org.uk/contact/.

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 data, advertising, or recruiting site, should contact the GLAD Study team at GLADadmin@kcl.ac.uk to express interest and get added to our waiting list.

Once our team has capacity to launch in your site, we can then begin discussions with the 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.

Does your trust have an IAPT service?

We have dedicated personnel within our team focused on IAPT recruitment. If your IAPT service would like to get involved in GLAD, then we will be able to move you up the waiting list. When emailing us, please mention IAPT recruitment in the subject line and we can begin discussing the steps to launch.

Questions?

Below please 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 Questions

How is the study funded?

The National Institute of Health Research (NIHR) is the primary funder of the GLAD Study.

What is the study end date?

Our CRN portfolio eligibility ends on 31/03/2022, 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.

Is the study offering any incentives to participants?

Due to the large scale of the study, there are no financial incentive for taking part. Participants are asked to join the study to help other people in the future. We send newsletters with updates on our research and have a resources page of helpful links. In addition, because they will be part of our database, participants may be invited to take part in other similar studies in which incentives may be offered.

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 other 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 emails 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 are eligible to take part.

  • Over 16
  • Experienced depression and/or anxiety (including bipolar, OCD, BDD, and OCD-related disorders) at any point in their life
  • Has capacity to consent

Are there any exclusion criteria?

No. There are no exclusion criteria (beyond individuals who do not meet eligibility criteria).

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 about the study on their own and is interested, they are still welcome to sign up.

Do patients need an ‘official’ diagnosis to take part?

No. Individuals are eligible regardless of diagnosis or treatment. An official diagnosis is therefore not required. For individuals 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. Eligibility of participants will be assessed centrally by the GLAD Study team based on responses to the questionnaire. It’s worth noting that all participants who have received an ‘official’ diagnosis will automatically be eligible, so this is a simple way for sites to verify if someone is assuredly eligible.

Do participants have to sign up to 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.

Participants 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.

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 trial?

No. This is a crucial item in our consent form as the aims of the study directly relate to combined analyses of 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.

How are accruals assigned?

Accruals will be assigned based on responses to the questionnaire. At the beginning of the questionnaire, we will ask participants if they heard about the 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 which 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 patients. If you are doing social media posts or advertising, we would also recommend including the trust name in the post. Local delivery teams approaching patients should always remind patients to indicate on the questionniare that they found out about the study through the site.

Who is responsible for uploading accrual/recruitment numbers to CPMS/EDGE?

According to the CRN, the GLAD Study is classed as an exception study. After 01/04/2019, our central GLAD study team will upload recruitment numbers to CPMS, and these numbers will then be populated into EDGE. NHS sites will not need to do any uploads to EDGE.

Will local sites need to backfill recruitment numbers to EDGE?

The CRN has confirmed that this won’t be necessary.

Can sites receive updates of their recruitment numbers?

Yes, our team aims to send out monthly updates of recruitment numbers. However, we have a small team here and a large number of sites to manage, so we apologise if these updates come less frequently. Please feel free to email us here at GLADadmin@kcl.ac.uk to request updated numbers, and we will send those to you as soon as we can.

Site Involvement

Are there any specific requirements for sites to run the study?

No. We have no requirements to be a site.

How can Primary Care get involved?

Primary Care can be added as recruiting sites or as PICs. Primary care recruiting sites will be able to take part in any of the recruiting activities listed above, same as the trusts. This can range from advertising, having clinicians mention the study to their patients, up to having a local research nurse consent/support participants signing up. Please note that Primary Care sites wishing to be recruiting sites will have to go through the full governance procedure to issue confirmation of capacity and capability in order to begin recruiting.

PIC sites will be asked to display posters and leaflets in waiting areas and to provide access to medical records for consented participants.

As mentioned above, Improving Access to Psychological Therapies (IAPT) services are also encouraged to get involved. The GLAD Study has tailored recruitment strategies for IAPT.

What are you doing about mail-out packs for GP practices?

We are currently trialing using text messages and mail-outs in a select number of GP practices. Practices interested in utilising these methods of recruitment should email our team to be kept up-to-date on the trial.

Can pharmacy care get involved?

Yes. Pharmacies are welcome to get involved as PICs or as recruiting sites. To be a recruiting sites, pharmacies will have to go through governance procedures to issue confirmation of capacity and capability before launching.

Are NHS local delivery teams sending out the saliva kits or is this done centrally by the study team?

NHS teams are welcome to collect saliva kits in the clinic, although this is optional. Typically, kits are sent from the central study team. If you would like your site to collect samples for the study, please contact our team.

Will NHS sites be involved in future study recall?

No. The GLAD team is responsible for inviting participants/research teams to collaborate in future researches. 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 CV’s/GCP’s for your files?

No.

Can you create localised versions of the participant information sheet/consent form?

The PIS and consent form are administered to patients online through the website. We can create a localised version of the PIS for sites to print out to give to patients, 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.

Are you happy with electronic site files?

Yes. Please keep electronic site files and send all site-related documents over email.

Costs

Is there any funding available to 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, co-morbidities) and treatment outcomes.