Condition category
Mental and Behavioural Disorders
Date applied
02/11/2016
Date assigned
16/11/2016
Last edited
05/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Ms Shireen Patel

ORCID ID

Contact details

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
+44 115 8231434
shireen.patel@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17959

Study information

Scientific title

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

Acronym

Study hypothesis

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

NRES Committee - London Riverside, 25/07/2014, ref: 14/LO/1102

Study design

Randomised; Both; Design type: Treatment, Psychological & Behavioural, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 144; UK Sample Size: 144

Participant 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

Recruitment start date

24/09/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Radford Medical Practice
Radford Health Centre Ilkeston Road
Nottingham
NG7 3GW
United Kingdom

Trial participating centre

The Valley Surgery
81 Bramcote Lane Chilwell
Nottingham
NG9 4ET
United Kingdom

Trial participating centre

Queens Medical Centre
DREEAM Emergency Department Nottingham University Hospitals NHS Trust Queens Medical Centre Campus Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

The Windmill Practice
Beaumont Street Sneinton
Nottingham
NG2 4PJ
United Kingdom

Trial participating centre

Sunrise Medical Practice
Clifton Campus Nottingham Trent University Clifton Lane
Nottingham
NG11 8NS
United Kingdom

Trial participating centre

Cripps Health Centre
The University of Nottingham University Park
Nottingham
NG7 2QW
United Kingdom

Trial participating centre

Hucknall Road Medical Centre
Kibworth Close
Nottingham
NG5 1NA
United Kingdom

Trial participating centre

Crown Medical Centre
21 First Ave
Mansfield
NG21 9DA
United Kingdom

Trial participating centre

The Family Medical Centre
171 Carlton Road
Nottingham
NG3 2FW
United Kingdom

Trial participating centre

Leen View Surgery
Bulwell Riverside Main Street
Bulwell
NG6 8QJ
United Kingdom

Trial participating centre

King's Mill Hospital
Endocrinology and Diabetes Sherwood Forest Hospitals NHS Foundation Trust Mansfield Road
Sutton in Ashfield
NG17 4JL
United Kingdom

Trial participating centre

Leicester Terrace Healthcare Centre
7-8 Leicester Terrace
Northampton
NN2 6AL
United Kingdom

Trial participating centre

Lakeside Surgery
Cottingham Road
Corby
NN17 2UR
United Kingdom

Trial participating centre

Nettleham Medical Practice
14 Lodge Lane Nettleham
Lincoln
LN2 2RS
United Kingdom

Trial participating centre

The Wolds Practice
West Road
Tetford
LN9 6QP
United Kingdom

Trial participating centre

St Mary's Medical Practice
Wharf Road
Stamford
PE9 2DH
United Kingdom

Trial participating centre

Welton Family Health Centre
4 Cliff Road Welton
Lincoln
LN2 3JH
United Kingdom

Trial participating centre

Birchwood Medical Practice
Jasmin Road Birchwood
Lincoln
LN6 0QQ
United Kingdom

Trial participating centre

Cliff House Medical Practice
82 Burton Road
Lincoln
LN1 3LJ
United Kingdom

Trial participating centre

Old Leake Medical Centre
The Medical Centre Old Leake
Boston
PE22 9LE
United Kingdom

Trial participating centre

Lindum Medical Practice
1 Cabourne Ct
Lincoln
LN2 2JP
United Kingdom

Trial participating centre

University Health Centre
Marina Building Brayford Pool
Lincoln
LN6 7GA
United Kingdom

Trial participating centre

The Sheepmarket Surgery
Ryhall Road
Stamford
PE9 1YA
United Kingdom

Trial participating centre

Derby Family Medical Centre
1 Hastings Street
Derby
DE23 6QQ
United Kingdom

Trial participating centre

Hockley Farm Medical Centre
Braunstone Health & Social Care Centre 39 Hockley Farm Road
Leicester
LE3 1HN
United Kingdom

Trial participating centre

The Forest Practice
Mary Potter Centre Gregory Boulevard
Nottingham
NG7 5HY
United Kingdom

Trial participating centre

Churchfields Medical Practice
Old Basford Health Centre 1 Bailey Street Old Basford
Nottingham
NG6 0HD
United Kingdom

Trial participating centre

Ashbourne Medical Practice
Clifton Road
Ashbourne
DE6 1DR
United Kingdom

Trial participating centre

Thurmaston Health Centre
573a Melton Road Thurmaston
Leicester
LE4 8EA
United Kingdom

Trial participating centre

Haywood Hospital Walk In Centre
High Lane
Burslem
ST6 7AG
United Kingdom

Trial participating centre

Somercotes Medical Centre
22 Nottingham Road Somecotes
Alfreton
DE55 4JJ
United Kingdom

Trial participating centre

Whitemoor Medical Centre
Whitemoor Lane
Belper
DE56 0JB
United Kingdom

Trial participating centre

Dronfield Medical Practice
High Street
Dronfield
S18 1PY
United Kingdom

Trial participating centre

The Deepings Health Centre
Godsey Lane Market Deeping
Peterborough
PE6 8DD
United Kingdom

Trial participating centre

Church Street Medical Practice
11b Church Street Eastwood
Nottingham
NG16 3BS
United Kingdom

Trial participating centre

Castle Healthcare Practice
Embankment Primary Care Centre 50-60 Wilford Lane West Bridgford
Nottingham
NG2 7SD
United Kingdom

Trial participating centre

East Bridgford Medical Centre
2 Butt Lane East Bridgford
Nottingham
NG13 8NY
United Kingdom

Trial participating centre

Bushloe Surgery
Two Steeples Medical Centre Abington Close
Wigston
LE18 2EW
United Kingdom

Trial participating centre

Castle Street Medical Centre
Castle Street Bolsover
Chesterfield,
S44 6PP
United Kingdom

Trial participating centre

Saffron Health
509 Saffron Lane
Leicester
LE2 6UL
United Kingdom

Trial participating centre

Dishley Grange Medical Practice
32 Maxwell Drive
Loughborough
LE11 4RZ
United Kingdom

Trial participating centre

Gosforth Medical Centre
Gorsey Brigg
Dronfield
S18 8UE
United Kingdom

Trial participating centre

Hollybrook Medical Centre
Hollybrrrok Way Heatherton
Derby
DE23 3TX
United Kingdom

Trial participating centre

Portland Medical Practice
60 Portland Street
Lincoln
LN5 7LB
United Kingdom

Trial participating centre

Castle Mead Medical Centre
Hill Street Hinckley
Leicester
LE10 1DS
United Kingdom

Trial participating centre

Charnwood Surgery
Mountsorrel Surgery 39 Linkfield Road
Mountsorrel
LE12 7DJ
United Kingdom

Trial participating centre

Limes Medical Centre
Limes Avenue
Alfreton
DE55 7DW
United Kingdom

Trial participating centre

Hannage Brook Medical Centre
Hannage Way Wirksworth
Matlock
DE4 4JG
United Kingdom

Trial participating centre

Heartwood Medical Practice
Civic Way
Swadlincote
DE11 0AE
United Kingdom

Trial participating centre

St Lawrence Road Surgery
19 St Lawrence Road
North Wingfield
S42 5LH
United Kingdom

Trial participating centre

Keyworth Medical Practice
Bunny Lane Keyworth
Nottingham
NG12 5JU
United Kingdom

Trial participating centre

Torkard Hill Medical Centre
Farleys Lane Hucknall
Nottingham
NG15 6DY
United Kingdom

Trial participating centre

Tong Medical Practice
Highfield Health Centre 2 Proctor Street
Bradford
BD4 9QA
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

Head of Research Governance
Research and Graduate Services
King’s Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
+44 115 9515679
sponsor@nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 plans:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/11/2017: 52 trial participating centres have been added.