Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients

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.

Study Overview

• Status: Recruiting
• Conditions: Personality Disorders; Bipolar Affective Disorder; Schizophrenia Disorders; Depression Disorders
• Intervention / Treatment: Other: Questionnaires, rating scales, & review of notes

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: David Hayward; Phone Number: 01506 523000; Email: david.hayward@nhslothian.scot.nhs.uk

Study Locations

• United Kingdom
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH16 4TJ
      • Recruiting
      • St John's Hospital
      • Contact: David Hayward; Phone Number: 01506523000; Email: d.a.hayward-1@sms.ed.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) consecutively admitted to NHS GAP inpatient wards in Scotland.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - Schizophrenia Group; Schizophrenia - 6A20; Schizoaffective disorder - 6A21; Delusional disorder - 6A24; Other primary psychotic disorders (psychosis NOS) - 6A2Z; Schizotypal disorder - 6A23	Other: Questionnaires, rating scales, & review of notes; Observational - questionnaires, rating scales, & review of notes
Group 2 - Bipolar Group; Bipolar type I disorder, current episode manic - 6A60 • without psychotic symptoms - 6A60.0 • with psychotic symptoms - 6A60.2; Bipolar type II disorder, current episode depressed, with psychotic symptoms - 6A60.6	Other: Questionnaires, rating scales, & review of notes; Observational - questionnaires, rating scales, & review of notes
Group 3 -Depression Group; Recurrent depressive disorder, current severe episode without psychotic symptoms - 6A71.3; Single episode depressive disorder, moderate with psychotic symptoms - 6A70.2; Recurrent depressive disorder (not otherwise specified) - 6A71; Mixed depressive and anxiety disorder - 6A73	Other: Questionnaires, rating scales, & review of notes; Observational - questionnaires, rating scales, & review of notes
Group 4 - Personality Group; Personality disorder - 6D10, 6D10.Z; Complex post-traumatic stress disorder - 6B41; Substance use disorders - 6C4* codes (e.g., 6C4G.1 alcohol, 6C45.6 sedative-hypnotic, 6C43.2 cannabis, 6C44.2 stimulants, 6C4Z unspecified)	Other: Questionnaires, rating scales, & review of notes; Observational - questionnaires, rating scales, & review of notes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; University of Dundee
• Investigators: Study Director: Douglas Steele, University of Dundee

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 8, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer; depression; mental health; schizophrenia; psychosis; respiratory disease; physical health; personality disorder; cardiometabolic disease; inpatients; NHS; treatment resistance; Bipolar affective disorder; General Adult Psychiatry
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Respiratory Tract Diseases; Mood Disorders; Behavior; Personal Satisfaction; Schizophrenia; Psychotic Disorders; Neoplasms; Depression; Bipolar Disorder; Respiration Disorders; Personality Disorders; Psychological Well-Being; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 337967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Access Criteria: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No