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| Name | Class |
|---|---|
| University of Dundee | OTHER |
| NHS Lothian | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Schizophrenia Group |
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| Group 2 - Bipolar Group |
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| Group 3 -Depression Group |
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| Group 4 - Personality Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires, rating scales, & review of notes | Other | Observational - questionnaires, rating scales, & review of notes |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of comorbid physical illnesses | As per medical note review and physical examination - BMI | At enrolment |
| Psychiatric diagnosis | ICD-11 codes | At enrolment |
| Severity of psychosis | Brief Psychiatric Rating Scale (BPRS) score; 18 to 126, higher scores indicate more severe symptoms | At enrolment |
| Depression of severity | Inventory of Depressive Symptomatology Self Report (IDS-SR); 0 to 84, higher scores indicate more severe symptoms | At enrolment |
| Severity of mania | Young Mania Rating Scale score; 0 to 60, higher scores indicate more severe symptoms | At enrolment |
| Severity of anxiety | General Anxiety Scale (GAD-7) score; 0 to 21, higher scores indicate more severe symptoms | At enrolment |
| Substance use | 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 | At enrolment |
| Mental Health Act status | MHA detention status; informal or detained |
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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)
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Adults (≥18 years) consecutively admitted to NHS GAP inpatient wards in Scotland.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Hayward | Contact | 01506 523000 | david.hayward@nhslothian.scot.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Douglas Steele | University of Dundee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St John's Hospital | Recruiting | Livingston | West Lothian | EH16 4TJ | United Kingdom |
Anonymous data only - diagnosis (ICD-11 codes), severity ratings (BPRS, IDS-SR, YMRS, Hamilton scales), MHA detention status, treatment resistance indicators (e.g., clozapine, ECT treatment, MGH-S), comorbid physical diagnoses, abnormal findings on physical examination, abnormal laboratory values, cardiometabolic measures
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Anonymous data available to co-investigators - diagnosis (ICD-11 codes), severity ratings (BPRS, IDS-SR, YMRS, Hamilton scales), MHA detention status, treatment resistance indicators (e.g., clozapine, ECT treatment, MGH-S), comorbid physical diagnoses, abnormal findings on physical examination, abnormal laboratory values, cardiometabolic measures
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| D010554 | Personality Disorders |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D011618 | Psychotic Disorders |
| D009369 | Neoplasms |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| At enrolment |
| Treatment resistance indicators | 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 | At enrolment |
| Rates of abnormal findings on physical examination | 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.. | At enrolment |
| Abnormal laboratory values | 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. | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - blood pressure mmHg | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - cardiometabolic disease | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - neurological disease. | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - musculoskeletal disease | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - respiratory disease | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - renal disease | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - hepatic disease | At enrolment |
| Rates of comorbid physical illness | As per medical note review and physical examination - haematological disease | At enrolment |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |