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Helping urgent care users cope with distress about physical complaints

Helping urgent care users cope with distress about physical complaints: A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66142865
Enrollment
144
Registered
2016-11-16
Start date
2014-09-24
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Mental Health, Primary sub-specialty: Anxiety Mental and Behavioural Disorders Anxiety

Interventions

Following eligibility screening and baseline assessment the researcher will enter the service user participants details onto a web-based randomisation system (set up by University of Nottingham Clinic
CTU). Participants will be allocated with equal probability to each treatment arm with stratification by region. Service user participants will be randomly allocated to one of two tre
cognitive biases (e.g. misinterpretations of physical sensations due to selectively attending to potential threats)
physiological sensations (e.g. pain and discomfort from excessive checking), and affective symptoms (e.g. anxiety and depression). The CBT intervention will be delivered remotely via video calling or

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. = 2 consultations, referrals or hospital admissions with any provider of unscheduled or emergency care (including urgent same day appointment at their general practice) in last 12 months for symptoms such as cardiac, respiratory, neurological, gastrointestinal or genitourinary problems not attributed to identified pathology 2. Scores above the threshold for severe health anxiety of 18 or more on the 14 item short form of the Health Anxiety Inventory (HAI) 3. Age 18 years and over 4. Sufficient understanding of English (spoken and written) to enable full engagement in the intervention 5. Able and willing to give oral and written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Pathological medical condition requiring further assessment or acute management, or pregnancy 2. Other severe mental illness (schizophrenia, bipolar disorder, severe major depressive episode, eating disorder) ascertained by the Structured Clinical Interview for DSM­IV Disorders (SCID, Spitzer et al., 2002) or anyone at immediate risk of harm to themselves or other people through their mental state 3. Organic mental disorder (dementia, delirium, substance use disorder, organic mood disorder) 4. Those already receiving specialist mental health intervention, including psychological treatment as part of specialist medical care e.g. pain clinic

Design outcomes

Primary

MeasureTime frame
Health anxiety is measured using the short form 14 item Health Anxiety Inventory (HAI) at baseline and 6 months.

Secondary

MeasureTime frame
.1 Health anxiety is measured using the Short form 14 item Health Anxiety Inventory (HAI) at baseline 3, 6, 9 and 12 months 2. Generalised anxiety is measured using the 7 item Generalised Anxiety Disorder (GAD) at baseline 3, 6, 9 and 12 months 3. Somatic distress is measured using the 15 item Patient Health Questionnaire (PHQ-15) at baseline 3, 6, 9 and 12 months 4. Depression is measured using the 9 item Patient Health Questionnaire for depression (PHQ-9) at baseline 3, 6, 9 and 12 months 5. Social function is measured using the 8 item Work and Social Adjustment Scale (WSAS) at baseline 3, 6, 9 and 12 months 6. v5 item quality of life on the EQ5D-5L (EuroQol) at baseline 3,6,9 and 12 months 7. Physical and Mental health status is measured using the 36 item Short Form Health Survey (SF-36) at baseline, 6 and 12 months 8. Number of contacts with unscheduled or emergency care established through a totally adapted and stylised Client Service Receipt Inventory (CSRI) at baseline, 3, 6, 9 and 12 months

Countries

England, United Kingdom

Contacts

Public ContactShireen Patel
shireen.patel@nottingham.ac.uk+44 115 8231434

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026