Bipolar Affective Disorder, Depression Disorders, Personality Disorders, Schizophrenia Disorders
Conditions
Keywords
General Adult Psychiatry, mental health, physical health, inpatients, schizophrenia, NHS, Bipolar affective disorder, depression, psychosis, treatment resistance, personality disorder, cardiometabolic disease, cancer, respiratory disease
Brief summary
This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) "mental health" inpatient wards, providing the first detailed information on morbidity in this patient population.
Detailed description
It is often supposed that most patients who attend secondary care General Adult Psychiatry (GAP) services would be excluded from clinical trials because they have too many co-morbidities, they are 'treatment resistant' (have a condition that does not improve despite trying two or more standard treatments), and their conditions are too severe. Hence, it would be helpful to properly measure these variables in GAP patients using questionnaires and a review of the case notes to see how many GAP patients would indeed be excluded from clinical trials. It is anticipated that this will show that the participants in clinical trials are very different from 'real life' GAP patients, and that could explain why some promising results from clinical trials do not translate into useful new treatments. Also, this data could act as a benchmark or baseline against which to measure the efficacy of novel treatments and interventions. PRIMARY OBJECTIVE Using the most commonly employed diagnostic tools, severity rating scales, and a systematic review of the case notes, the typical characteristics of GAP patients will be described. SECONDARY OBJECTIVES The above data will be used to compared 'typical/real life' patients with the participants in impactful clinical trials. This is a cross sectional quantitative study. Participants will spend about an hour attending to the questionnaires and talking to their clinician. STUDY SETTING The study will take place in St John's Hospital, Livingston, West Lothian, on the acute psychiatric ward, and the outpatient department. STUDY POPULATION 100 patients who attend the West Lothian NHS GAP service will be consecutively recruited. These participants will be between 18 and 65 years old and suffering from mental disorders that their GP could not treat. IDENTIFYING PARTICIPANTS The usual clinical team will ask eligible patients if they would like to participate. CONSENTING PARTICIPANTS Consent will be thoroughly informed by an information leaflet and subsequent discussion with the involved clinician. Participants will take the information leaflet away with them and express their consent, or not, in their own time by using the contact details on the information leaflet, or when they next see their clinician. WITHDRAWAL OF STUDY PARTICIPANTS Participants will have the option of withdrawal from all aspects of the trial, but the data collected up to that point could be used. To safeguard rights, the minimum personally identifiable information possible will be collected. There are no stopping rules. Participants could withdraw at any time.
Interventions
OTHERQuestionnaires, rating scales, & review of notes
Observational - questionnaires, rating scales, \& review of notes
Sponsors
University of Edinburgh
University of Dundee
NHS Lothian
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: \- Adults aged between 18 and 65 years admitted to GAP wards during recruitment period Exclusion: \- Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of comorbid physical illnesses | At enrolment | As per medical note review and physical examination - BMI |
| Psychiatric diagnosis | At enrolment | ICD-11 codes |
| Severity of psychosis | At enrolment | Brief Psychiatric Rating Scale (BPRS) score; 18 to 126, higher scores indicate more severe symptoms |
| Depression of severity | At enrolment | Inventory of Depressive Symptomatology Self Report (IDS-SR); 0 to 84, higher scores indicate more severe symptoms |
| Severity of mania | At enrolment | Young Mania Rating Scale score; 0 to 60, higher scores indicate more severe symptoms |
| Severity of anxiety | At enrolment | General Anxiety Scale (GAD-7) score; 0 to 21, higher scores indicate more severe symptoms |
| Substance use | At enrolment | Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool score; tobacco 0 to 3, alcohol 0 to 4, others 0 to 21, higher scores indicate more risky use |
| Mental Health Act status | At enrolment | MHA detention status; informal or detained |
| Treatment resistance indicators | At enrolment | Clozapine for psychosis, and ECT treatment and Massachusetts General Hospital Staging (MGH-S) score for depression. MGH-S uses the number of failed trials with the intensity/optimization of each trial to produce a score where \>3.5 defines treatment resistant depression |
| Rates of abnormal findings on physical examination | At enrolment | When psychiatric patients are admitted to hospital, they are examined by a resident doctor, including inspection, auscultation, and palpation. Rates of abnormal findings on cardiovascular , respiratory, abdominal, and neurological examination will be noted.. |
| Abnormal laboratory values | At enrolment | When psychiatric patients are admitted to hospital, screening blood tests, including full blood count, urea and electrolytes (kidney), liver function tests, random glucose, cholesterol, triglycerides, and thyroid function tests. |
| Rates of comorbid physical illness | At enrolment | As per medical note review and physical examination - blood pressure mmHg |
Countries
United Kingdom
Contacts
CONTACTDavid Hayward
STUDY_DIRECTORDouglas Steele
University of Dundee
Outcome results
None listed