Morriss et al. BMC Medicine(2019) 17:16
https://doi.org/10.1186/s12916-019-1253-5

RESEARCH ARTICLE

Open Access

Clinical and economic outcomes ofremotely delivered cognitive behaviour
therapy versus treatment as usual for
repeat unscheduled care users with severe
health anxiety: a multicentre randomised
controlled trial
Richard Morriss1* , Shireen Patel1, Sam Malins1, Boliang Guo1, Fred Higton1, Marilyn James2, Mengjun Wu2,
Paula Brown3, Naomi Boycott3, Catherine Kaylor-Hughes1, Martin Morris4, Emma Rowley5, Jayne Simpson3,
David Smart6, Michelle Stubley1, Joe Kai7 and Helen Tyrer8

Abstract
Background: It is challenging to engage repeat users of unscheduled healthcare with severe health anxiety inpsychological help and high service costs are incurred. We investigated whether clinical and economic outcomes
were improved by offering remote cognitive behaviour therapy (RCBT) using videoconferencing or telephonecompared to treatment as usual (TAU).
Methods: A single-blind, parallel group, multicentre randomised controlled trial was undertaken in primary andgeneral hospital care. Participants were aged ≥18 years with ≥2 unscheduled healthcare contacts within 12 months
and scored >18 on the Health Anxiety Inventory. Randomisation to RCBT or TAU was stratified by site, withallocation conveyed to a trial administrator, research assessors masked to outcome. Data were collected at baseline,
3, 6, 9 and 12 months. The primary outcome was change in HAI score from baseline to six months on an intentionto-treat basis. Secondary outcomes were generalised anxiety, depression, physical symptoms, function and overall
health. Health economics analysis was conducted from a health service and societal perspective.
Results: Of the 524 patients who were referred and assessed for trial eligibility, 470 were eligible and 156 (33%)
were recruited; 78 were randomised to TAU and 78 to RCBT. Compared to TAU, RCBT significantly reduced healthanxiety at six months, maintained to 9 and 12 months (mean change difference HAI –2.81; 95% CI –5.11 to –0.50; P= 0.017). Generalised anxiety, depression and overall health was significantly improved at 12 months, but there wasno significant change in physical symptoms or function. RCBT was strictly dominant with a net monetary benefit of£3,164 per participant at a willingness to pay threshold of £30,000. No treatment-related adverse events werereported in either group.
(Continued on next page)* Correspondence: richard.morriss@nottingham.ac.uk
1
Division of Psychiatry and Applied Psychology, Institute of Mental Health,
University of Nottingham, Triumph Road, Nottingham NG7 2TU, UK
Full list of author information is available at the end of the article© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Morriss et al. BMC Medicine(2019) 17:16

Page 2 of 13(Continued from previous page)

Conclusions: RCBT may reduce health anxiety, general anxiety and depression and improve overall health, withconsiderable reductions in health and informal care costs in repeat users of unscheduled care with severe healthanxiety who have previously been difficult to engage in psychological treatment. RCBT may be an easy-toimplement intervention to improve clinical outcome and save costs in one group of repeat users of unscheduledcare.
Trial registration: The trial was registered at ClinicalTrials.gov on 19 Nov 2014 with reference number NCT02298036
Keywords: Illness anxiety disorder, Hypochondriasis, Depression, High care costs, Urgent care, Family care, Cognitive
behaviour therapy, Digital, Videoconferencing, Remote therapy

Introduction
In health services, unscheduled same-day care is defined as
any unplanned contact with a health service by a person requiring or seeking help, care or advice [1]. Globally, unscheduled same-day care is increasing across primary andhospital care settings, presenting a burgeoning challenge
for health systems [2–4]. Severe health anxiety, which is defined as a preoccupation with health worries or a belief that
one might have a serious physical illness [5], is one possible
reason for repeated use of unscheduled care. Severe healthanxiety is a common feature of healthcare, with a lifetime
prevalence of 8.5% in primary care and 24% in hospital
clinics [6, 7]. Severe health anxiety can lead to increasedunscheduled care use for reassurance and increased medical investigations, or delayed healthcare attendance
followed by catastrophic emergency presentation becauseof anxiety-related healthcare avoidance. It may increase
people’s functional impairment, sickness absence, risk ofcardiovascular disease and other chronic physical or mental
health problems and increase healthcare costs [8–10].
Cognitive behaviour therapy (CBT) is a well-evidenced
treatment for severe health anxiety, with benefits lastingat least five years [11–13]. Despite the effectiveness of
CBT for health anxiety, uptake is typically low becauseof stigma and negative experiences of mental health services [14, 15]. Remotely delivered CBT (RCBT), whereby
patients talk directly to a CBT therapist using
internet-based videoconferencing and/or the telephone,
may enhance accessibility, acceptability and service capacity for patients with severe health anxiety. For anxiety
and somatic disorders, RCBT can achieve comparable
outcomes to face-to-face treatment [16, 17]. Digitally delivered psychological therapies are generally more effective when supported by a therapist, as opposed to being
unguided or self-guided [18, 19]. Therefore, use of atherapist via the phone or online might maintain the efficacy of CBT for health anxiety. Furthermore, remotedelivery may improve access for those who are concerned about using mental health services, live in rural
areas with reduced access to services, travel frequently
or are restricted by comorbid health conditions, familycare or work commitments.

The rationale for this study was that if repeat users ofunscheduled care with severe health anxiety could be easily identified in routine healthcare settings by health professionals with whom they already have an establishedrelationship, then an acceptable explanation of their problems might be facilitated through a trusted source. Offering RCBT in an accessible format, via videoconferencing
or telephone, may then enable participants to become engaged with treatment more easily. We used a model of
CBT that previously showed sustained reductions inhealth anxiety over five years [11], but delivered it remotely to a targeted high service-use population. For
health anxiety, CBT promotes self-management techniques that may sustainably improve health anxiety. This
may reduce the need to seek reassurance from health professionals and informal carers, or more timely care for serious health problems may be sought, reducing the needfor emergency in-patient care. In turn, health and informalcare costs might be reduced.
The primary aim of this study was to assess the clinicaland economic outcomes of RCBT via videoconferencing
or telephone to repeat users of unscheduled care withsevere health anxiety compared to usual care.

Methods
Study design and participants

We conducted a single-blind, patient-level, parallel group,
multicentre randomised controlled trial (RCT) in primaryand secondary care centres across the East Midlands and at
two other English sites. Participants were recruited fromemergency departments, walk-in centres, hospital outpatient clinics and GP practices offering same-day appointments. Participants were approached if they were aged 18
years and over; had two or more unscheduled consultations
with any healthcare provider in the last 12 months, not attributed to identified pathology; met criteria for clinical severity of health anxiety (a score of 18 or above on the
14-item Short Health Anxiety Inventory, SHAI [20, 21])and had sufficient understanding of English to engage with
the intervention. A SHAI score ≥18 is the clinical cut-off
used by Improving Access to Psychological Therapies in
the UK to identify patients who meet the diagnostic criteria

Morriss et al. BMC Medicine(2019) 17:16

for hypochondriasis/severe health anxiety. Patients were excluded if they were at immediate risk of harm to themselves
or others; had moderate to severe learning disability; a serious mental or physical illness, including substance use disorder, to the extent that engagement in the intervention
would not be possible, e.g. communication difficulties; werereceiving ongoing investigations for a pathological medical
condition; or had received specialist mental health intervention within the previous six months. We intentionally included those diagnosed with chronic physical conditions orcommon mental health problems. The trial protocol is published [22].
Randomisation and masking

Randomisation was determined by a computer-generated
pseudo-random code using random permuted blocks of 2,
4 or 6, created by the Nottingham Clinical Trials Unit inaccordance with their standard operating procedure andheld on a secure server. Participants were allocated withequal probability (1:1) to each treatment arm, with stratification by site. The administration officer relayed treatment allocation information to CBT therapists andparticipants. Only the trial manager and the administration support officer had password access to theun-blinded randomisation data. The researchers responsible for collecting the baseline and outcome data wereblind to randomisation until collection of all data wascomplete. Any instances of un-blinding were recorded.
Procedures

The principles of user-design and co-production were
utilised by developing a network of patient and public
involvement (PPI) members, health practitioners and researchers contributing at all stages of the study including
study design, recruitment, RCBT delivery methods andinterpretation of results [23]. In particular, iterative feedback with this network of practice and the experience of
PPI members meant we could develop and use engaging,
non-stigmatising explanations in study procedures andmaterials and adopt simple, flexible procedures to identify, recruit and retain patients.
Referring clinicians approached patients meeting eligibility criteria and sought consent for them to be contacted
by study researchers. Referrers explained to patients thatthe aim of the study was to find out whether talking to ahealth professional via videoconferencing or telephonemight help them to cope better with distress linked totheir bodily symptoms. Most practitioners approached patients opportunistically during usual care consultations,based on their clinical knowledge of the patient. They also
used electronic administrative prompts on patient medical
notes, which highlighted repeat users of urgent ‘same-day’appointments. Some practitioners posted study invitation
letters to patients who might meet the study criteria after

Page 3 of 13

electronically searching patient records. One primary care
centre sent out text messages to such patients.
A researcher telephoned potential participants who
provided written or verbal consent. The researcher explained they had been referred to the study because they
had been experiencing physical symptoms and associated distress and that talking therapy via videoconferencing or telephone may help to manage distress.
Participants were informed they had a 1 in 2 chance ofreceiving the RCBT intervention and that the study was
being offered as an additional source of support, rather
than replacing or restricting their current healthcare use.
No participant was told that an aim of the study was toreduce service use. Further study information was
posted to all participants prior to a baseline assessment
interview, which was arranged at a time and place suitable for the patient. Verbal and written consent was received at this baseline assessment interview. Following
assessment and confirmation of eligibility, participants
were randomly allocated to one of two treatment arms:
RCBT in addition to usual treatment, or treatment as
usual (TAU).
Remote cognitive behaviour therapy (RCBT)

Participants allocated to the RCBT arm were provided
with a detailed information sheet about RCBT, an RCBT
guide, a manual to help set up the videoconferencing system (where used) and a contingency management plan forwhen connection was poor or not possible. A CBT therapist contacted participants within 10 days of randomisation.
A team of four experienced CBT therapists remotely delivered CBT for health anxiety using a treatment manualdeveloped from the Cognitive Behavioural Therapy for
Health Anxiety in Medical Patients (CHAMP) study [15].
Between six and 12 sessions of CBT were offered, with up
to three booster sessions if required. This included an initial ‘setup’ session, during which the methods used toadapt CBT to remote delivery were discussed and any
concerns about this method were addressed. The numberof sessions offered depended on treatment response: moresessions were offered when treatment response wasslower. Treatment used CBT principles to assess and test
beliefs about health, illness and associated issues that werelikely to be causing distress. Behavioural strategies known
to maintain health anxiety were identified and collaboratively reduced or stopped (Additional file 1: Table S1). Participants also received text messages/email reminders
about their CBT sessions. Participants were free to continue to consult their usual healthcare providers otherthan the CBT therapist throughout the intervention andafter treatment completion.
RCBT was delivered via a videoconferencing systemcalled WebEx or by telephone, depending on the participant’s preference. WebEx was selected because of

Morriss et al. BMC Medicine(2019) 17:16

connection security and interactive utilities enabling anexperience close to face-to-face CBT. At the time of assessment, compared to nine other piloted systems, WebEx
was also comparatively cheaper. Permission was sought torecord audio/video during treatment sessions. These wereaccessible to participants as a means of consolidating
learning from each session.
Recordings were also used for assessment and improvement of therapeutic quality in the clinical supervision of CBT therapists. Group clinical supervision was
conducted monthly via WebEx. Audio/video recordingsof the most recent sessions with patients who were notresponding to treatment were reviewed and appropriate
treatment approaches were discussed. The lead therapist
from the CHAMP trial (HT) conducted clinical oversight [11]. A version of the Cognitive Therapy Rating
Scale Revised (CTSR) [24], adapted to health anxiety,
was used for two randomly selected sessions given byeach therapist at four time points to assess, maintainand improve therapist competence and treatment fidelity. In this way, remote delivery meant that a few therapists could be used to consistently deliver theintervention over a large geographical area.
Treatment as usual (TAU)

Usual care included informing the participant, their GP
and any other healthcare referrer of the participant’s involvement in the study. For participants whose baseline
assessment scores suggested risk of harm to themselves
or others, or if they required a referral to a different service, a phone call was made and a letter sent to referrers
including to deliver information regarding the patient’s
severity of health anxiety, risk of harm, other comorbidities and their quality of life. Treatment as usual was
unconstrained.
Outcomes

The primary clinical outcome was change in SHAI scorefrom baseline to six months. Secondary outcomes werechange in the following self-reported measures frombaseline to 12 months:
 SHAI [21].
 7-item Generalised Anxiety Disorder for anxiety(GAD-7) [25].
15-item Patient Health Questionnaire for somatic
distress (PHQ-15) [26].
9-item Patient Health Questionnaire for depression(PHQ-9) [27].
8-item Work and Social Adjustment Scale for social
function (WSAS) [28].
5-item quality of life on the EQ5D-5L including the
Visual Analogue Scale (VAS) [29].

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 36-item Short Form Health Survey (SF-36) [30].
 Change in health care service utilisation establishedthrough an adapted Client Service Receipt Inventory(CSRI) [31].
At the baseline assessment only, participants were interviewed using a standardised psychiatric interview [32] to
identify mental disorders. All baseline assessments wereconducted by te study researchers, either face-to-face or bytelephone, dependent on the participant’s preference. All
measures were selected because they have a history of routine use in settings within the UK National Health Service(NHS), should RCBT be implemented into NHS practice.
Follow-up assessments were carried out at three, six, nineand 12 months by telephone, email, videoconferencing,
post, or face-to-face, dependent on participant preference.
Health economics

Health economic analysis was conducted from a healthservice and societal perspective. Resource use data werecollected at baseline, three, six, nine and 12 months
using the adapted CSRI, which included sections on outpatient hospital appointments, inpatient stays, primaryand community care services, medicines and informalcare visits. For each type of health and social care services use, an appropriate unit cost was identified andvalued using NHS reference costs from the reference
year 2017 [33] for both the RCBT intervention and TAU
groups. The intervention cost of using the technology
was further determined. Outcome was obtained in thesame periods using the EQ5D-5L [29] to calculatequality-adjusted life-years (QALYs).
The incremental cost-effectiveness ratio (ICER) was
calculated for the RCBT intervention versus treatment
as usual:
ICER ¼ ðCostCBT −CostTAU Þ=ðQALYCBT −QALYTAU Þ
The threshold of £30,000 per QALY, set by the National Institute for Health and Care Excellence (NICE)[34] to assess the cost-effectiveness of RCBT. The RCBT
intervention is deemed to be cost-effective if ICERs fall
below this value.
Statistical analysis

The analysis was conducted on an intention-to-treat
basis. Multilevel modelling was performed to quantify
the treatment effects, with patient as a level 2 unit.
Time, treatment status and treatment × time interactions and baseline measurements were included as covariates. Secondary outcomes were analysed in a similar
way. Missing values were explored and imputed under
the Missing At Random assumption [35]. Sensitivity
analysis was conducted with the same multilevel modelMorriss et al. BMC Medicine(2019) 17:16

on observed data to check the result’s robustness to
missingness. Stata 15 (StataCorp LLC, USA) and
Realcom-impute (University of Bristol, UK) software
were used for data analysis. More details can be foundon the trial statistical analysis plan [36].
Sample size and calculation

The results of the CHAMP study [15] showed thatthe mean SHAI scores for CBT and TAU groups
were 24.9 (SD 4.2) and 25.1 (SD 4.5), respectively, atbaseline and 17.7 (SD 8.0) and 22.6 (SD 6.8), respectively, at six months. Therefore, 114 participants
were required to detect such a difference in SHAI
score at six months to achieve 90% power at a
two-tailed significance level of 0.05, assuming equal
SD (8.0) for both groups and null correlation between baseline and follow-up measures for the purpose of being conservative. After taking into accounta 20% loss to follow-up rate, a required sample size

Page 5 of 13

of 144 was calculated. Stata 14 (StataCorp LLC,
USA) was used to run the power analysis. In September 2016, we observed that our follow-up rate
for the primary outcome measure was 75%. Thus, todetect a difference, the sample size was increased to152. Approval was obtained from the study sponsor,
an independent scientific committee and ethics committee to recruit additional participants, resulting ina sample size of 156 participants.

Results
Of the 524 patients referred to the study and assessed
for eligibility between 19 November 2014 and 31 December 2016, 470 were eligible and 156 (33%) participants were recruited. Seventy-eight participants wereallocated to RCBT and 78 to TAU (Fig. 1). Researchers
were inadvertently un-blinded to 17 participants in the
RCBT group and one participant in the TAU group. No

Fig. 1 Consort diagram: participant flow into randomised controlled trial. *There was one randomization protocol violation. One participant who
was allocated into TAU by the randomisation system was accidentally sent the incorrect treatment allocation letter, resulting in them receiving
the RCBT therapy. This error was identified following the completion of treatment. The participant completed outcome data only at threemonths. **There was an enrolment protocol violation. Two participants in the RCBT group did not meet the criteria of ≥18 on the SHAI. This error
was not identified until final analysis and as such both participants were included in the analysis

Morriss et al. BMC Medicine(2019) 17:16

treatment-related adverse events were reported in eithergroup.
Baseline characteristics for the two groups were similar (Table 1 and Additional file 1: Table S2). At baseline,
RCBT and TAU groups had median unscheduled
face-to-face healthcare consultations of 6.5 (IQR 3-12)
and 5 (IQR 3-10), respectively, in the preceding 12months. Most participants (80%) were referred from primary care by their GP. Two-thirds were female and half
were under 35 years of age, although there was a wide
age range. At baseline, mean (SD) SHAI scores for the
RCBT and TAU arms were 27.31 (5.38) and 26.41 (5.13),
respectively. Table 1 shows that the mean (SD) scores atbaseline on the GAD-7 and the PHQ-9 were above clinical cut-offs ( >8 and>10, respectively) for both groups[21], indicating that clinically important comorbid generalised anxiety and depression were typically present
alongside severe health anxiety. There were no clinicallyimportant differences at baseline for any demographic or
clinical characteristic between the two treatment arms.
RCBT participants received a median of eight sessions(range: 0–16) with 55 (71%) participants completingtherapy or attending ≥5 sessions. Forty-seven (60%) received sessions via WebEx, 20 (25%) had sessions bytelephone and 11 (14%) received no sessions. Therapist
competency assessments using the CTSR indicated CBTskill levels between the ‘competent’ and ‘proficient’ range
for all therapists, with an overall trend of improved skill
over time. Follow-up completion rates were similar between the two groups. In TAU and RCBT arms, 8(10.2%) and 2 (2.6%, 7–12 months) participants, respectively, received ≥2 sessions of any additional psychological treatment.
Table 2 and Fig. 2 show that participants in both arms
experienced a reduction in health anxiety, with participantsin the RCBT arm showing significantly greater reduction at
six months (mean change difference at six months –2.81
95% CI –5.11 to –0.50; P = 0.017), 9 and 12 months. Analysis confined only to participants with complete data atbaseline and six months showed nearly identical results(Additional file 1: Figure S1 and Table 3). Recovery rates
on the SHAI are shown in Additional file 1: Table S4. Participants in the RCBT arm also showed significantly greater
reductions in generalised anxiety (GAD-7) at six and 12
months, depression (PHQ-9) at 12 months and overall
health (VAS) at 12 months. No significant differences were
found on the PHQ-15 or WSAS between the two groups
at any time point. SF-36 results confirm improvements ingeneral health, with no differences in any other domain(Additional file 1: Table S5).
Table 3 shows the total costs per patient over the
12-month follow-up. While there was no evidence of asignificant difference in cost per patient between the
RCBT intervention and TAU groups, there was aPage 6 of 13

significant reduction in the mean cost of inpatient hospital use (P = 0.031).
Including the cost of providing RCBT, the mean overall cost saving per patient over 12 months with RCBT,
healthcare, medication, travel and informal care costs
was £1,064 (95% CI –£845–£2973, P = 0.269). The mean
cost of providing RCBT was calculated at £531.80 (95%CI £466.80–£597.80).
QALYs were 0.66 and 0.59 for the intervention groupand the control group, respectively; this difference at 12
months was not significant (Table 2). However, the ICER
for QALYs was –£15,200 (the difference in cost, –£1,064, divided by the difference in QALYs, 0·07), whichhighlights additional expenditure to gain additional
QALYs. It is clear to see that the RCBT intervention represents lower cost and more QALYs; that is, the RCBT
intervention is in a position of strict dominance.
ΔCost
Cost CBT −Cost TAU¼
ΔQALY QALY CBT −QALY TAUÁÁÁÁ
E2197−E3261 −E1; 064¼¼¼ −E15; 200
0:66−0:59
0:07

ICER ¼

The uncertainty around the ICER was explored, giventhat the ICER is based on sample means (Additional file 1:
Table S6). A negative ICER is nevertheless not easily interpretable. Therefore, the net monetary benefit (NMB) was
calculated as:ðincremental benefit  willingness‐to‐pay ðWTPÞ thresholdÞ
incremental cost

A positive NMB indicates that the intervention iscost-effective compared to the alternative and vice versa.
We chose a WTP of £30,000, as recommended by NICE
guidelines [34]; the NMB at £30,000 is £3,164 with observed values. Positive NMBs were generated using a
range of WTPs from £5,000 to £35,000, i.e. bothcost-saving and the cost-effectiveness are achieved by the
RCBT intervention compared to TAU (Table 4). Overall,the RCBT intervention is in a position of strict dominance, which means delivering the RCBT intervention
could reduce costs and demonstrate cost-effectivenesscompared to TAU using both the observed and multiple
imputation values.
Figure 3 illustrates a cost-effectiveness plane (CEP),
where the scatter of points is based on the results of anon-parametric bootstrap analysis (5,000 replications)on total costs and QALYs. The scatter of points ismainly based in the southeast quadrant. In the southeast
quadrant, the CBT intervention is more effective andless costly for health anxiety and thus dominates TAU.
For a given threshold of £30,000 by NICE, all points
below this threshold are deemed to be cost-effectiveMorriss et al. BMC Medicine(2019) 17:16

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Table 1 Baseline characteristics of participants
RCBT (n = 78)

TAU (n = 78)

Age, median (range) years

31.12 (18.36–79.10)

33.28 (18.69–82.71)

Female, n (%)

56 (72)52 (67)

Employed, n (%)

32 (41)29 (37)

Student/training, n (%)

27 (35)24 (31)

Homemaker, n (%)

0

2 (3)

Occupational status

Retired, n (%)

7 (9)10 (13)

Unemployed, n (%)

12 (15)13 (17)First degree or higher, n (%)

24 (31)25 (32)

A-Level or other higher qualification, n (%)

28 (36)30 (38)

O-Level/GCSE or other qualification, n (%)

19 (24)20 (26)No qualifications, n (%)

7 (9)

3 (4)

Married/partner, n (%)

32 (41)39 (50)Single, n (%)

34 (45)32 (41)

Divorced/widowed, n (%)

10 (13)7 (9)58 (74)58 (74)GP, n (%)

63 (81)62 (79)

Medical specialties, n (%)

9 (12)7 (9)Emergency department, n (%)

4 (5)

6 (8)

Walk-in centre, n (%)

2 (3)

3 (4)

SHAI, mean (SD)27.31 (5.38)

26.41 (5.13)

GAD7, mean (SD)12.94 (5.49)

12.68 (6.13)

PHQ9, mean (SD)13.35 (6.50)

13.12 (6.71)

PHQ15, mean (SD)14.16 (5.63)

13.90 (6.45)

EQ5D-5L Utility Value, mean (SD)0.61 (0.28)

0.60 (0.29)

Highest qualification

Marital status

Ethnicity
White British, n (%)aReferral type

Baseline scores

VAS, mean (SD)54.76 (21.72)

56.97 (22.58)

WSAS, mean (SD)19.33 (11.40)

20.35 (10.54)

SF36 Physical functioning, mean (SD)67.29 (30.39)

64.18 (32.04)

Role limitations – physical health, mean (SD)29.81 (39.08)

28.90 (40.77)

Role limitations – emotional problems, mean (SD)35.47 (42.07)

27.35 (41.17)

Energy/fatigue, mean (SD)25.73 (20.39)

27.05 (22.48)

Emotional well-being, mean (SD)40.92 (19.88)

42.54 (24.83)

Social functioning, mean (SD)45.83 (29.10)

46.31 (30.82)

Pain, mean (SD)47.47 (24.83)

41.38 (26.96)

General health, mean (SD)28.27 (19.29)

36.25 (22.89)

Unscheduled care attendances in last 12 months, median (range)

6.5 (2.0–125.0)

5.0 (2.0–34.0)

afurther detail provided in Additional file 1

Morriss et al. BMC Medicine(2019) 17:16

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Table 2 Multilevel modelling of changes in score from baseline to 12 month follow-up for remote cognitive behavioural therapy(RCBT) intervention versus treatment as usual (TAU)
RCBT

TAU

Comparison

N

Mean change from baseline (95% CI)

N

Mean change from baseline (95% CI)

Difference (95% CI)

P-value

3 months

53–6.08(–7.90 to –4.26)

48–5.97(–7.97 to –3.97)–0.11(–2.82 to 2.60)

0.936

6 months

56–9.48(–11.20 to –7.75)

56–6.67(–8.30 to –5.04)–2.81(–5.11 to –0.50)

0.017

9 months

46–9.58(–11.33 to –7.84)

50–6.78(–8.43 to –5.12)–2.81(–5.11 to –0.50)

0.017

12 months

47–10.60(–12.31 to –8.89)

47–7.79(–9.43 to –6.16)–2.81(–5.11 to –0.50)

0.017

3 months

52–3.69(–5.09 to –2.28)

48–4.79(–6.17 to –3.41)

1.10(–0.84 to 3.05)

0.265

6 months

53–6.22(–7.62 to –4.82)

55–3.83(–5.21 to –2.44)–2.39(–4.40 to –0.39)

0.020

9 months

43–5.37(–7.05 to –3.69)

48–4.48(–5.97 to –2.99)–0.89(–3.00 to 1.23)

0.408

12 months

45–6.68(–8.14 to –5.21)

46–3.92(–5.40 to –2.45)–2.75(–4.82 to –0.68)

0.009

3 months

52–3.24(–4.69 to –1.80)

47–3.01(–4.38 to –1.64)–0.23(–2.15 to 1.68)

0.812

6 months

53–4.67(–6.02 to –3.33)

55–3.11(–4.46 to –1.76)

1.56(–3.45 to 0.33)

0.105

9 months

43–4.41(–6.06 to –2.76)

48–3.24(–4.78 to –1.69)–1.17(–3.18 to 0.83)

0.250

12 months

45–5.05(–6.37 to –3.72

45–2.69(–4.06 to –1.31)–2.36(–4.22 to –0.50)

0.013

3 months

52–0.35(–1.58 to 0.88)

48–1.68(–3.16 to –0.19)

1.33(–0.52 to 3.17)

0.157

6 months

54–2.95(–4.11 to –1.78)

55–1.62(–2.90 to –0.34)–1.33(–3.09 to 0.42)

0.137

9 months

45–2.62(–4.19 to –1.04)

49–2.20(–3.47 to –0.92)–0.42(–2.38 to 1.53)

0.669

12 months

46–3.33(–4.62 to –2.04)

47–1.77(–2.99 to –0.55)–1.57(–3.37 to 0.24)

0.089

3 months

52

8.74 (3.70 to 13.79)

47

2.80(–2.35 to 7.96)

5.94(–1.22 to 13.11)

0.103

6 months

54

13.66 (8.97 to 18.34)

55

11.10 (6.32 to 15.89)

2.56(–4.03 to 9.14)

0.446

9 months

45

10.24 (5.28 to 15.21)

49

2.92 (–2.06 to 7.90)

7.33(–0.02 to 14.67)

0.051

12 months

46

13.80 (8.90 to 18.71)

47

4.25 (–0.87 to 9.37)

9.56 (2.73 to 16.39)

0.006

3 months

51–4.45(–6.63 to –2.27)

48–3.36(–5.61 to –1.10)–1.10(–4.07 to 1.87)

0.468

6 months

53–7.52(–9.85 to –5.19)

55–4.89(–7.03 to –2.75)–2.63(–5.72 to 0.45)

0.094

9 months

44–7.31(–9.81 to –4.81)

56–5.77(–8.15 to –3.39)–1.54(–4.99 to 1.90)

0.377

12 months

45–7.89(–10.22 to –5.56)

56–5.40(–7.79 to –3.01)–2.49(–5.73 to 0.75)

0.131

SHAI

GAD 7

PHQ9

PHQ15

EQ5D–5L (VAS)

WSAS

RCBT
a

QALYs at 12 months

TAU

Unadjusted difference in changeN

Mean (SD)nMean (SD)

Mean (95% CI) (P-value)31

0.66 (0.22)

25

0.59 (0.31)

0.07 (0.07 to 0.21) (0.332)

a

QALYs at 12 months is based on the complete dataset over the 12-month follow-ups

because the CBT intervention is dominant in the southeast quadrant.

Discussion
This study is the first to apply targeted, real-time, remotely
delivered CBT to address the clinical needs of repeat usersof unscheduled care with severe health anxiety and the related costs to health services. Results suggest that RCBT iseffective in reducing severe health anxiety at six months,
sustained to at least 12 months, while also reducing comorbid generalised anxiety and depression and improving
overall health in patients recruited from primary and secondary care services. The benefits are similar to thoseachieved when offering face-to-face CBT for health anxiety with more selected groups such as hospital clinic attenders [11, 13]. No differences were found between

Morriss et al. BMC Medicine(2019) 17:16

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Fig. 2 Mean (95% CI) change in 14-item Short Health Anxiety Inventory over 12 months remote cognitive behaviour therapy versus treatment
as usualparticipants in the RCBT or TAU groups in terms of either somatic symptoms or work and social adjustment.
The RCBT intervention showed a position of strict economic dominance, with a net monetary benefit of £3,164
per participant at a NICE-determined WTP threshold of£30,000. Higher rates of recruitment (33% of those eligible) than previous trials of psychological interventions infrequently attending patients with health anxiety [11, 37]
suggest that the recruitment methods involving
non-stigmatising explanation and RCBT were acceptable.
Overall, our results suggest that targeted remote deliveryof CBT is a feasible, clinically effective and cost-saving
method of improving self-management in repeat users ofunscheduled care with severe health anxiety, with whom
health systems have previously struggled to engage.
Strengths

The study successfully recruited participants with highlevels of unscheduled healthcare use and severe healthanxiety; and those with clinical levels of comorbid depression, generalised anxiety, other bodily symptoms and poor
quality of life. The use of telephone and videoconferencing
interviews allowed participants of all backgrounds to beengaged and recruited, particularly those who may havebeen resistant or unable to access traditional mental
health services. Most participants were recruited throughTable 3 Costs (£) per participant over 12-month follow-up period remote cognitive behaviour therapy versus treatment as usual
RCBT

TAU

Unadjusted difference in changenMean (SD)nMean (SD)

Mean (95% CI) (P-value)

CBT sessions

78

496 (294)

78

0 (0)

496 (431 to 562) (0.000)

Technology

7835.8 (0)

78

0 (0)

35.8 (35.8 to 35.8) (N/A.)

Outpatient hospital visits35

608 (871)34

728 (706)–120 (–502 to 261) (0.531)

Inpatient hospital visits38

22 (87)37258 (656)–236 (–450 to –23) (0.031)

Primary and community care38

798 (838)

35

2066 (5224)–1,268 (–2,981 to 444) (0.144)

Travel33

36 (46)35

50 (109)–14 (–55 to 27) (0.495)

Medication37

219 (402)34

436 (1082)–217 (–597 to 163) (0.259)

Informal care36

162 (536)34

293 (1253)–130 (–586 to 325) (0.569)

Total cost

292197 (1048)

26

3261 (5010)–1064 (–2973 to 845) (0.269)

Morriss et al. BMC Medicine(2019) 17:16

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Table 4 The net monetary benefit of remote cognitive behaviour therapy versus treatment as usual at various willingness to pay(WTP) thresholds using EQ-5D-5L utilities
Net monetary benefit
WTP threshold£5,000£10,000£15,000£20,000£25,000£30,000£35,000

Observed values£1,414£1,764£2,114£2,464£2,814£3,164£3,514usual care clinical encounters, particularly in primary care,rather than large-scale screening procedures in general
hospital outpatient departments or direct public adverts
used in previous studies [9, 38–40]. The methods used
may be more easily incorporated into routine health system procedures than has been typical.
This study confirms previous findings that similar
treatment effects achieved with face-to-face CBT canalso be realised using remotely delivered CBT [11–13].
Furthermore, the pragmatic, applied methods used inthis trial mean the results are potentially generalisable toroutine clinical practice in UK and other similar healthservices.
The study further provides evidence that the user-designand co-production approach we applied through networks
of practice [23] may have improved both engagement andrecruitment to the study as a whole and to RCBT in particular. A non-stigmatising explanation of health anxiety
and its effects, coupled with the delivery of RCBT, might beutilised as a promising means of engaging repeat users ofunscheduled care with severe health anxiety into effective
treatment. Furthermore, the higher rates of recruitment
might also be attributed to the accessibility andconvenience of the RCBT intervention for each participant. The delivery methods also helped provide a complex intervention over a large area, with acomparatively small staff team, in terms of both conducting the research and the RCBT.
Limitations

The requirement for only two unscheduled care appointments in the previous 12 months may appear arbitrary intriaging patients at high risk of anxiety-related service use.
By not setting different thresholds for males and females,
we may have recruited a greater proportion of females
than males [41]. However, we recruited participants withmuch higher baseline use of repeat unscheduled care in
the preceding year using this easily applied cut-off, suggesting an appropriate set of inclusion criteria for clinicaluse and that the gender composition of the sample would
not have been different if we had applied a higher cut-off
score.
We recognise that using digital technology in theintervention group may have led to the selection ofyounger participants, although participants up to the ageof 79 years utilised RCBT. However, use of the internet

Fig. 3 Plot of bootstrapped samples on the cost-effectiveness plan using EQ-5D-5L utilities

Morriss et al. BMC Medicine(2019) 17:16

does not necessarily mean that older participants could
not be recruited, nor that RCBT is ineffective in older
adults [38–40].
One of the main limitations of the trial was reduced
retention in follow-up. However, achieving 72% at six
months for our primary outcome is considerable, given
the complexities of this patient group, within routine
care across sectors. Lower rates of follow-up might be
expected in studies of harder-to-engage patients [42].
Similar results were obtained using only participants
who provided six months of follow-up data as whenusing imputed data in the intention-to-treat analysis,suggesting that the results are robust. A further limitation is that lower follow-up rates at three, nine and 12
months than at six months mean there is less precision
concerning the treatment effects at these time points
than at six months. Further independent replication in alarger sample would be desirable to test the robustnessof our findings. We did not inspect patients’ primarycare and general hospital records because self-report
may be more accurate in patients who frequently utilise
multiple sources of unscheduled care from different
agencies [37, 43].
Unlike some other internet and face-to-face delivered
CBT for health anxiety [15, 38–40], there was no difference in outcome at three months in our RCT. In thecurrent RCT, participants had previously received nodiagnosis or explanation for health anxiety, until, that is,health anxiety was explained to all participants as part ofthe informed consent process. As a result, there was asubstantial mean drop in the SHAI score of 6 points
from baseline in both treatment groups at three months,
with no benefit of RCBT over TAU emerging until six
months. Participants commented on the value of receiving an explanation of health anxiety to make sense of
their symptoms and, furthermore, around 10% of TAU
participants sought psychological treatment over 12months. In contrast, participants in most previous RCTs
already had a diagnosis or understood they might have
health anxiety before participation.
Implications

Further research should explore whether the benefits of
RCBT in repeat users of unscheduled care with severe
health anxiety are maintained beyond 12 months [11]. Further research is also required to directly compare the parityof effectiveness of RCBT, face-to-face delivery and blended
approaches utilising both face-to-face and remote therapies, according to participant and therapist preference.
At a time of financial restraint within health services,
this study presents a promising intervention that canboth improve the health of a hard-to-reach population
and reduce the cost to health services. We will separately report further qualitative data on the acceptability

Page 11 of 13

of the intervention. The pragmatic design of this RCTmeans procedures could be used in routine NHS care tofacilitate low-cost implementation. Such an approach requires integration of care: participants are engaged
through primary care and some hospital departmentsthat provide continuing care, RCBT is delivered by psychological treatment providers and the benefits to thehealthcare system are to the participant, their personal
support network (informal care), primary care and hospital services.
For those who are unwilling or unable to engage inface-to-face CBT for health anxiety in existing psychological treatment services, our methods of explanation
and remote delivery may provide a cheap, effective andimplementable method of delivering CBT to repeat usersof unscheduled care with high health anxiety, instead of
costly collusion of clinicians in a cycle of repeat investigation, inter-specialist referral, additional medicationand clinician perpetuated follow-up [8, 10, 44].

Conclusion
Compared to usual care, RCBT may reduce health anxiety at six, nine and 12 months, and improve generalanxiety, depression and overall health at 12 months. It
may also reduce health and informal care costs in theorder of £1,000 per patient over 12 months in repeat
users of unscheduled care with severe health anxiety.
These patients have previously been difficult to engage
in psychological treatment, but in this trial, about
one-third were successfully engaged.
Additional file
Additional file 1: Table S1. Essentials of specific elements of cognitive
behaviour therapy for health anxiety. Table S2. Diagnostic anddemographic features of participants (N=156). Figure S1. Observed
mean (95% CI) change in Short Health Anxiety Inventory over 12 months
remote cognitive behaviour therapy versus treatment as usual. Table S3.
Change in SHAI scores over 12 months (observed value). Table S4.
Recovery and remission rates on 14-item Health Anxiety Inventory in remotecognitive behaviour therapy and treatment as usual groups. Table S5.
Changes from baseline on SF36 domains in remote cognitive behaviour
therapy (RCBT) and treatment as usual (TAU). Table S6. Incremental costeffectiveness ratios (ICERS) for remote cognitive behaviour therapy (RCBT)
and treatment as usual (TAU). (DOCX 50 kb)
Abbreviations
CBT: Cognitive behaviour therapy; CHAMP: Cognitive Behavioural Therapy for
Health Anxiety in Medical Patients; CSRI: Client Service Receipt Inventory;
CTSR: Cognitive Therapy Rating Scale Revised; EQ5D-5L: Euroqol health utility
measure; GAD-7: 7-item Generalised Anxiety Disorder scale; ICER: Incremental
cost effectiveness ratio; IQR: Interquartile range; NHS: UK National HealthService; NICE: National Institute for Health and Care Excellence; NMB: Net
monetary benefit; PHQ-9: 9-item Personal Health Questionnaire; PHQ-15: 15item Personal Health Questionnaire; PPI: Patient and public involvement;
QALY: Quality adjusted life year; RCBT: Remotely delivered cognitive
behaviour therapy; RCT: Randomised controlled trial; SF-36: Short Form
Health Survey, 36 item version; SHAI: 14-item Short Health Anxiety Inventory;
TAU: Treatment as usual; VAS: Visual analogue scale; WASAS: Work and Social
Adjustment Scale; WTP: Willingness to pay threshold

Morriss et al. BMC Medicine(2019) 17:16

Acknowledgements
This research drew on the expertise of the NIHR MindTech HealthTechnology Co-operative and Nottingham NIHR Biomedical Research Centre
Mental Health and Technology Theme, especially in relation to the testing
and application of the technology used in the trial. The authors would liketo thank all participants and clinicians who recruited participants to the trial.
Special thanks to Public Involvement representatives David Waldram andFred Higton for all their advice and continuing support. We acknowledge
the help and support of the NIHR Clinical Research Network in the East
Midlands and Staffordshire and Stoke on Trent Partnership NHS Trust. We
would like to thank Julie Moss for providing administrative support throughout
the trial. We would also like to thank the University of Nottingham for providing
sponsorship and the Nottingham Clinical Trials Unit support for this trial
Funding
This study was funded by the National Institute for Health Research (NIHR)
Collaboration for Leadership in Applied Health Research and Care East
Midlands, with matched funding from NHS Trust sites and the University of
Nottingham. The funders had no role in the study design, data collection,
analysis, interpretation of results or write-up. The views expressed in thispublication are those of the authors and not necessarily those of the NHS,
the NIHR or the Department of Health and Social Care.
Availability of data and materials
The datasets analysed during the current study are available from thecorresponding author on reasonable request.
Authors’ contributions
All authors contributed to writing the manuscript. RM was the chief
investigator, obtained funding, designed the study and interpreted the data
and as the corresponding author was the data custodian, had full access tothe data and overall responsibility for the submission of the paper. SM andHT designed the study, supervised and delivered the therapy and interpreted
the data. PB, NB and MM co-designed and delivered the digital therapy. SP
designed the study, co-ordinated the trial, monitored the recruitment strategy,
supervised research assessments and interpreted the data. MS designed thestudy and carried out research assessments. BG devised the statistical plan andconducted the statistical analysis and interpretation. MJ designed the study,
supervised the economic analysis and its interpretation. MW conducted theeconomic analysis and its interpretation. CK-H was the trial manager andsupervised data entry and analysis. JK and DS co-produced the design of thestudy from a primary care perspective and JK substantially amended themanuscript from a primary care perspective. FH designed the study, interpreted
the data and provided PPI input. All authors read and approved the final
manuscript
Ethics approval and consent to participate
Ethical approval was obtained from the National Research Ethics Service
London – Riverside Committee (reference 14/LO/1102). All participants gave
written informed and oral consent to the study, directly to a member of theresearch team.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.

Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.
Author details
1
Division of Psychiatry and Applied Psychology, Institute of Mental Health,
University of Nottingham, Triumph Road, Nottingham NG7 2TU, UK. 2Divisionof Rehabilitation and Ageing, University of Nottingham, School of Medicine,
Nottingham NG7 2UH, UK. 3Nottinghamshire Healthcare NHS Foundation
Trust, Duncan MacMillan House, Porchester Road, Nottingham NG3 6AA, UK.
4
Leicestershire Partnership NHS Trust, Plaza, Riverside House Bridge Park,
Bridge Park Road, Thurmaston, Leicester LE4 8PQ, UK. 5Business School,
University of Nottingham, Wollaton Road, Nottingham NG8 1BB, UK.

Page 12 of 13

6

Leicester Terrace Health Centre, Adelaide St, Northampton NN2 6AL, UK.
Division of Primary Care, University of Nottingham, School of Medicine,
Nottingham NG7 2UH, UK. 8Department of Psychiatry, Imperial College,
South Kensington Campus, London SW7 2AZ, UK.

7

Received: 2 October 2018 Accepted: 7 January 2019

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