INCLUDE: Using Lived Experience to Improve Mental Health Diagnosis v1 (NCT03131505) | Clinical Trial Compass
CompletedNot Applicable
INCLUDE: Using Lived Experience to Improve Mental Health Diagnosis v1
United Kingdom59 participantsStarted 2017-02-22
Plain-language summary
The focus of this study is not about what it is like to have a mental disorder, but instead the diagnostic experience.
Some people find diagnoses helpful, but some find them upsetting and harmful. Research is therefore needed to improve diagnostic processes. It has been suggested that patient experiences and outcomes may be affected by the diagnostic tools used, including diagnostic criteria, labels and language. In the NHS, the tool used by doctors to help diagnose people is a guidebook called the International Classification of Diseases (ICD). A new version of this guide is due to be released in 2018.
This project will use focus groups to ask people who use mental health services and diagnosing doctors in those services what they think about the labels and language in the new guide. The investigators can then suggest changes before the guide is published. The investigators hope that this research will improve mental health diagnosis. The research will take place in Norfolk and Suffolk and span eight months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult service users will have formally received one of the five diagnoses under investigation: Unipolar Depression, Schizophrenia, Bipolar Disorder, Generalised Anxiety Disorder or Personality Disorder.
. Clinicians will have had experience working with mental health, either as a GP or psychiatrist, where diagnosing any of the above diagnoses is part of their role.
. Carers will have had experience looking after someone with the above diagnoses.
. Service users with multiple diagnoses will be allowed to participate, and choose which one of the relevant focus groups they would like to attend.
. Service users will be under the care of an NSFT service.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Qualitative evaluation of the impact of new ICD-11 diagnostic criteria via focus groups with people living with mental health conditions and clinicians.
. Individuals who do not have capacity to give consent.
. Individuals who lose capacity during the study.
. Individuals who do not speak English.
. Individuals will be excluded if their participation is deemed unsafe to themselves or others by their lead clinician or clinicians on the research team.
. Individuals who have taken part in another group or part of the study.