Helping urgent care users cope with distress about physical complaints
ISRCTN | ISRCTN66142865 |
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DOI | https://doi.org/10.1186/ISRCTN66142865 |
Secondary identifying numbers | 17959 |
- Submission date
- 02/11/2016
- Registration date
- 16/11/2016
- Last edited
- 05/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Each year many people make use of Accident & Emergency departments, walk in centres or make an urgent same day appointment with their GP. This is "unscheduled care". Doctors may be unable to tell these patients what exactly is causing their symptoms, which can be painful and cause distress if they are not able to be treated. Six percent of the population have excessive anxiety or worry about their health. Health anxiety costs the NHS in England an estimated £3 billion per year in unnecessary costs. Health anxiety is persistent worry about health and can have a severe detrimental and debilitating impact on overall health. Despite the availability of effective treatment for health anxiety, few people take it up. Psychological therapy delivered remotely (over the telephone or the internet) has been found to help patients where anxiety or stigma may cause reluctance to access mental health services face-to-face. Remotely delivered psychological therapy has equivalent rates of recovery and patient satisfaction to face-to-face delivery. Given the accessibility and cost benefits, remotely delivered therapy may be a suitable delivery option for this patient group. In this study, a remotely delivered cognitive behavioural therapy (a type of taking therapy which aims to change the way a person thinks and behaves) to people with high health anxiety that access unscheduled/urgent care. The aim of this study is to investigate the effectiveness of this program.
Who can participate?
Adults who have had at least two consultations, referrals or hospital admissions in the last 12 months who experience health anxiety.
What does the study involve?
A member of staff from the hospital, GP Practice or out of hours service introduces the study to potential participants. If the patient agrees to be contacted by a researcher then they are called to see if the study is suitable for them. If eligible the member of the research team will arrange to meet with them or ask to carry out an interview over the phone, whichever approach is most convenient. The researcher then answers any questions and asks for written consent to take part in the study. The participants are asked some questions about physical and mental health and use of health services. The interview is expected to last around one and a half hours. Participants would only need to meet with once for this. After this, participants are randomly allocated to one of two study groups. Those in the first group continue to receive usual care only for the duration of the study. Those in the second group are offered the remotely delivered cognitive behavioural therapy (CBT) program. This involves 6-12 sessions of CBT either via video calling (similar to skype) or over the telephone. CBT sessions aim to identify how thoughts, feelings and actions affect the symptoms experienced. All participants are also asked to complete a set of questionnaires three, six, nine and twelve months after they have been interviewed.
What are the possible benefits and risks of participating?
By taking part participants may receive treatment which helps with their symptoms. The questionnaires and interview completed as part of the research enables reflection on symptoms and emotions and how these have changed over the research period. The study may also help patients in the future to get treatment that helps them manage their difficulties, and cope better with their pain or associated symptoms. Some of the questions asked enquires about symptoms including emotions such as feeling anxious or low. Whilst most people do not mind answering these questions, some people may feel upset. It is important that we ask these questions and find out if treatment can improve these symptoms. Many people find talking about or sharing concerns in a safe and confidential way can be helpful.
Where is the study run from?
Radford Medical Practice (lead site) and 52 other medical practices (UK)
When is the study starting and how long is it expected to run for?
January 2014 to December 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Shireen Patel
shireen.patel@nottingham.ac.uk
Contact information
Public
NIHR Collaboration for Leadership in Applied Health Research and Care
(CLAHRC) East Midlands
C Floor
Institute of Mental Health Building
University of Nottingham
Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
Phone | +44 115 8231434 |
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shireen.patel@nottingham.ac.uk |
Study information
Study design | Randomised; Both; Design type: Treatment, Psychological & Behavioural, Qualitative |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Helping urgent care users cope with distress about physical complaints: A randomised controlled trial |
Study objectives | The aim of this study is to: 1. Determine the clinical and cost effectiveness of remotely delivered cognitive behaviour therapy for health anxiety in repeated users of unscheduled/urgent primary or secondary care for physical symptoms without an underlying physical health cause# 2. Determine what aspects might facilitate and hinder the delivery of remote CBT and how such treatment might fit into a wider care pathway to enhance patient experience of care |
Ethics approval(s) | NRES Committee - London Riverside, 25/07/2014, ref: 14/LO/1102 |
Health condition(s) or problem(s) studied | Specialty: Mental Health, Primary sub-specialty: Anxiety |
Intervention | 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 Clinical trial Unit; 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 treatment arms: remote CBT intervention (in addition to usual treatment) or treatment as usual only. Remotely delivered CBT intervention: A team of experienced CBT practitioners will deliver CBT for health anxiety remotely using a treatment manual developed from the CHAMP study (Tyrer, 2013). Six to twelve sessions will be offered. The intervention will address the symptoms of health anxiety from a cognitive-behavioural perspective. This will include safety- seeking behaviours (e.g. reassurance seeking or phobic avoidance); 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 over the telephone depending on the participant’s preference. Upon completion of the remote treatment intervention participants from the remote intervention treatment arm of the study will be continue to access their usual care services. A summary of the finalised treatment action plan will then be distributed to the participant and their GP or other healthcare providers with the participant’s consent. Treatment as usual: Treatment as usual will be that decided by the service user with their general practitioner and other clinicians they consult for unscheduled care. Treatment as usual will be unconstrained other than it will not be provided by the treatment intervention therapists. Follow up questionnaires will be completed by participants in both arms at 3, 6, 9 and 12 months. All outcome data will be collected single blind at 3, 6, 9 and 12 months from randomisation except for the SF-36 which will be collected at 6 and 12 months only. |
Intervention type | Behavioural |
Primary outcome measure | Health anxiety is measured using the short form 14 item Health Anxiety Inventory (HAI) at baseline and 6 months. |
Secondary outcome measures | .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 |
Overall study start date | 01/01/2014 |
Completion date | 31/12/2017 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 144; UK Sample Size: 144 |
Key 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 |
Key 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 |
Date of first enrolment | 24/09/2014 |
Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Ilkeston Road
Nottingham
NG7 3GW
United Kingdom
Chilwell
Nottingham
NG9 4ET
United Kingdom
Emergency Department
Nottingham University Hospitals NHS Trust
Queens Medical Centre Campus
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sneinton
Nottingham
NG2 4PJ
United Kingdom
Nottingham Trent University
Clifton Lane
Nottingham
NG11 8NS
United Kingdom
University Park
Nottingham
NG7 2QW
United Kingdom
Nottingham
NG5 1NA
United Kingdom
Mansfield
NG21 9DA
United Kingdom
Nottingham
NG3 2FW
United Kingdom
Main Street
Bulwell
NG6 8QJ
United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield Road
Sutton in Ashfield
NG17 4JL
United Kingdom
Northampton
NN2 6AL
United Kingdom
Corby
NN17 2UR
United Kingdom
Nettleham
Lincoln
LN2 2RS
United Kingdom
Tetford
LN9 6QP
United Kingdom
Stamford
PE9 2DH
United Kingdom
Welton
Lincoln
LN2 3JH
United Kingdom
Birchwood
Lincoln
LN6 0QQ
United Kingdom
Lincoln
LN1 3LJ
United Kingdom
Old Leake
Boston
PE22 9LE
United Kingdom
Lincoln
LN2 2JP
United Kingdom
Brayford Pool
Lincoln
LN6 7GA
United Kingdom
Stamford
PE9 1YA
United Kingdom
Derby
DE23 6QQ
United Kingdom
39 Hockley Farm Road
Leicester
LE3 1HN
United Kingdom
Gregory Boulevard
Nottingham
NG7 5HY
United Kingdom
1 Bailey Street
Old Basford
Nottingham
NG6 0HD
United Kingdom
Ashbourne
DE6 1DR
United Kingdom
Thurmaston
Leicester
LE4 8EA
United Kingdom
Burslem
ST6 7AG
United Kingdom
Somecotes
Alfreton
DE55 4JJ
United Kingdom
Belper
DE56 0JB
United Kingdom
Dronfield
S18 1PY
United Kingdom
Market Deeping
Peterborough
PE6 8DD
United Kingdom
Eastwood
Nottingham
NG16 3BS
United Kingdom
50-60 Wilford Lane
West Bridgford
Nottingham
NG2 7SD
United Kingdom
East Bridgford
Nottingham
NG13 8NY
United Kingdom
Abington Close
Wigston
LE18 2EW
United Kingdom
Bolsover
Chesterfield
S44 6PP
United Kingdom
Leicester
LE2 6UL
United Kingdom
Loughborough
LE11 4RZ
United Kingdom
Dronfield
S18 8UE
United Kingdom
Heatherton
Derby
DE23 3TX
United Kingdom
Lincoln
LN5 7LB
United Kingdom
Hinckley
Leicester
LE10 1DS
United Kingdom
39 Linkfield Road
Mountsorrel
LE12 7DJ
United Kingdom
Alfreton
DE55 7DW
United Kingdom
Wirksworth
Matlock
DE4 4JG
United Kingdom
Swadlincote
DE11 0AE
United Kingdom
North Wingfield
S42 5LH
United Kingdom
Keyworth
Nottingham
NG12 5JU
United Kingdom
Hucknall
Nottingham
NG15 6DY
United Kingdom
2 Proctor Street
Bradford
BD4 9QA
United Kingdom
Sponsor information
University/education
Head of Research Governance
Research and Graduate Services
King’s Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
Phone | +44 115 9515679 |
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sponsor@nottingham.ac.uk | |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | 31/12/2018 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Data sharing statement to be made available at a later date |
Publication and dissemination plan | A multi-faceted educational approach such as workshops, brief academic papers and electronic and paper disseminated information such as BITEs and video clips will be used appropriately for both internal and external communication. The results will be publicised through the extensive arrangements for dissemination locally within the CLAHRC (through road shows, website and annual conferences) as well as publications in peer reviewed journals, alongside local, national and international scientific conferences. |
IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Basic results | 29/01/2019 | 29/01/2019 | No | No | |
Protocol article | 25/02/2016 | 05/10/2022 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN66142865 _BasicResults_29Jan19.pdf
- Uploaded 29/01/2019
Editorial Notes
05/10/2022: Publication reference added.
29/01/2019: The basic results of this trial has been uploaded as an additional file
05/11/2017: 52 trial participating centres have been added.