Behavioural and Cognitive Psychotherapy, 2018, 46, 129–147

First published online 29 August 2017 doi:10.1017/S1352465817000492

Is Cognitive Behavioural Therapy focusing on Depression and

Anxiety Effective for People with Long-Term Physical Health
Conditions? A Controlled Trial in the Context of Type 2
Diabetes Mellitus

Abigail L. Wroe

Department of Psychology, Royal Holloway University of London, Egham, UK and Clinical Health
Psychology Service, Berkshire Healthcare NHS Foundation Trust, Reading, Berkshire, UK

Edward W. Rennie

Talking Therapies, Berkshire Healthcare NHS Foundation Trust, Reading, Berkshire, UK

S. Sollesse

Talking Therapies, Berkshire Healthcare NHS Foundation Trust, Reading, Berkshire, UK

J. Chapman

Talking Therapies, Berkshire Healthcare NHS Foundation Trust, Reading, Berkshire, UK

A. Hassy

Talking Therapies, Berkshire Healthcare NHS Foundation Trust, Reading, Berkshire, UK and Theale
Medical Surgery, North West Reading CCG, Berkshire, UK

Background: It is unclear as to the extent to which psychological interventions focusing

specifically on depression and anxiety are helpful for people with physical health conditions,
with respect to mood and condition management. Aims: To evaluate the effectiveness of a
modified evidence-based psychological intervention focusing on depression and anxiety for
people with type 2 diabetes mellitus (T2DM), compared with a control intervention. Method:
Clients (n = 140) who experienced mild to moderate depression and/or anxiety and had a
diagnosis of T2DM were allocated to either diabetes specific treatment condition (n = 52) or

Correspondence to Dr Abigail L Wroe, Department of Psychology, Royal Holloway University of London, Holloway
Hill, Egham, Surrey TW20 0EX, UK. E-mail: abigail.wroe@rhul.ac.uk

© British Association for Behavioural and Cognitive Psychotherapies 2017

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 130 A. L. Wroe et al.

standard intervention (control condition, n = 63), which were run in parallel. Each condition
received a group intervention offering evidence-based psychological interventions for people
with depression and anxiety. Those running the diabetes specific treatment group received
additional training and supervision on working with people with T2DM from a clinical health
psychologist and a general practitioner. The diabetes specific treatment intervention helped
patients to link mood with management of T2DM. Results: Both conditions demonstrated
improvements in primary outcomes of mood and secondary outcome of adjustment [95%
confidence interval (CI) between 0.25 and 5.06; p < 0.05 in all cases]. The diabetes specific
treatment condition also demonstrated improvements in secondary outcomes of self-report
management of T2DM for diet, checking blood and checking feet, compared with the control
condition (95% CIs between 0.04 and 2.05; p < 0.05 in all cases) and in glycaemic control (95%
CI: 0.67 to 8.22). The findings also suggested a non-significant reduction in NHS resources
in the diabetes specific treatment condition. These changes appeared to be maintained in the
diabetes specific treatment condition. Conclusions: It is concluded that a modified intervention,
with input from specialist services, may offer additional benefits in terms of improved diabetic
self-management and tighter glycaemic control.

Keywords: CBT, depression, self-care, diabetes, long-term physical health conditions

Introduction
Type 2 diabetes mellitus (T2DM) is a condition characterized by high blood sugars due
to increasing insulin resistance and insufficient insulin production to match the digested
carbohydrate load. Management of the condition requires control of blood sugars (glycaemic
control) through behaviour change, medication or the use of insulin injections. Poor glycaemic
control results in vascular damage that in turn leads to a range of end organ damage
that either accelerates natural ageing processes prematurely or the development of diabetes
specific complications most commonly, but not exclusively, ophthalmic, renal, cardio- and
cerebrovascular, and peripheral nerve damage (Tidy and Kenny, 2013). This can result in
disability, early reduction of working life, and reduced quality of life (Lin, 2010; Egede
and Ellis, 2010). T2DM is rapidly escalating in prevalence and is predicted to do so further
according to Diabetes UK. Recent figures suggest that 3.2 million people in the UK have been
diagnosed with T2DM, with an estimated further 0.5 million currently undiagnosed (Diabetes
UK, 2014). An additional aspect to consider is the economic cost of T2DM. As a result of the
prevalence, as well as complications associated with the condition, research has shown that
T2DM consumes approximately 10% of the NHS budget (Hex et al., 2012).
The fundamental principle of holistic diabetic care is that lifestyle behaviour underpins the
effectiveness of all other medical treatments. The first intervention before oral hypoglycaemic
agents is to adopt a low sugar diet, adopt a low fat diet for people who are overweight and engage
in regular activity as necessary for weight loss, and reduce or stop unhealthy behaviours such
as tobacco smoking (NICE, 2014). Patients are also encouraged to check their feet regularly.
This is because patients with diabetes are more susceptible to infection generally, the feet
and ankles are more susceptible to delayed healing due to general poorer circulation, and
people with progressive diabetes often lack the ability to sense when they damage their feet,
meaning foot ulcers are likely to be missed. Assuming healthy medical lifestyle behaviours
is also important, including taking regular medication, most commonly as either tablets or
injectables (including insulin). Such interventions are generally offered in primary care settings,

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by GPs and/or diabetes nurses, sometimes in the form of a group education programme such
as X-Pert Diabetes Programme (Deakin et al., 2006). Patient focused care and supporting
self-management remains the central founding principle of optimizing diabetic control with a
current focus on markers of physical health and continual annual screening for early detection
of complications.
Anxiety and depression are common in people with T2DM, and can act as a barrier to
self-care and management. Research has suggested that the rate of depression in people with
T2DM is about twice that of the background rate (Ali et al., 2006; Anderson et al., 2001) and
a third of people with T2DM experience ‘mild to severe’ anxiety (Collins et al., 2009). It is
recognized that dealing with common mental health issues such as depression and anxiety are
important in supporting people with T2DM (Diabetes UK, 2010; Snoek et al., 2000; PCDS,
2011). Furthermore, it is proposed that treating depression and anxiety in people with long-
term physical illness has an economic benefit in reducing physical healthcare usage (Layard
and Clark, 2014). A systematic review by Molosankwe et al. (2012) concluded that there is an
association between co-morbid diabetes and depression/anxiety, and increasing health service
utilization and cost.
There is debate as to whether interventions should focus on depression and anxiety in
isolation to self-management or focus also on self-management itself, with Lustman’s group
concluding that ‘depression in diabetes cannot be managed as if it is an entity isolated from
the medical illness’ (Lustman and Clouse, 2002). It has been suggested that psychological
interventions that are effective in improving blood markers, as well as psychological distress,
not only focus specifically on depression and anxiety, but include a range of approaches such
as motivational interviewing, couple therapy, attitudes around diabetes, and often with other
disciplines such as behaviour modification by a nutritionist/clinical nurse specialist, and input
from an exercise psychologist (Alam et al., 2009; Ismail et al., 2004; van der Feltz-Cornelis
et al., 2010). Lustman’s position is further strengthened by the fact that there is little research
evidence supporting the argument that psychological work focusing specifically on depression
and anxiety is effective in the management of T2DM. In a systematic review, Markowitz
et al. (2011) demonstrated that whilst showing improvements in depression, the efficacy of
interventions focusing on depression (including cognitive behavioural therapy) in improving
glycaemic control was mixed. It is possible therefore that, as part of holistic care in supporting
behaviour change, interventions are required to focus not only on depression and anxiety, but
on other barriers to behaviour change, such as illness beliefs, which are key elements of health
psychology models (Leventhal et al., 1997). It is likely then that inclusion of a clinical health
psychology approach is necessary for psychological interventions to be effective in terms of
behaviour change around management of the condition.
The Department of Health, UK proposed a four-year plan to integrate the treatment of
people with long-term physical illness into the national primary care psychology programme
known as ‘IAPT’ (‘Increasing Access to Psychological Therapies’) (Department of Health,
2011). IAPT services offer stepped care evidence-based therapies for people with anxiety
and depression (with or without co-morbidity of long-term health conditions), with the least
intensive intervention at step 2, such as guided self-help or 6-session wellbeing groups; and
more intensive intervention (up to 16 individual sessions), including group interventions, at
step 3. This stepped care model has shown success in delivering efficient and cost-effective
psychological services on a large scale nationally. Given the debate around the efficacy of
interventions focusing on depression and anxiety for people with T2DM, it is fundamental

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 132 A. L. Wroe et al.

to understand whether evidence-based interventions such as cognitive behavioural therapies

for depression and anxiety are effective for people with long-term health conditions such
asT2DM in terms of depression and anxiety; as well as in terms of the management of the
long-term physical illness, adjustment and healthcare cost. A previous paper suggested that
provision of a standard IAPT group intervention on depression and anxiety did not impact
on glycaemic control (Wroe et al., 2015). Furthermore, this service development pilot work
which preceded the current research (Wroe et al., 2015) found that attendance rates were
low, outcome measures suggested no improvements in anxiety and depression, and that there
was no change in management of T2DM when applying the standard group inervention to
patients with T2DM. The paper reports a series of adaptations that were made, using additional
psychological competences, to develop an intervention that was effective in terms of both mood
and management of T2DM, yet still boundaried in evidence-based, low-intensity (step 2)
interventions (NICE, 2009a,b; NICE, 2011a,b). Furthermore, the modified group intervention
potentially demonstrated some improvement in glycaemic control. It was concluded that the
psychological intervention is effective only when practitioners were ‘upskilled’ in competences
in working with people with T2DM through clinical skills training and clinical supervision
(offered by a GP and a clinical health psychologist), and when the intervention was specifically
tailored to issues around living with T2DM. The standard intervention, focusing only on
depression and anxiety, was effective neither in terms of mood nor management of T2DM.
However, the findings are limited due to small numbers of participants. The aim of this
current study is to evaluate systematically the effectiveness of this modified group intervention
as reported by Wroe et al. (2015), compared with the standard group intervention, among
adults with T2DM, in terms of primary outcomes of symptoms of anxiety and depression,
and secondary outcomes of management of diabetes [as measured by self-report scale, and
glycaemic control (HbA1c)], adjustment and subsequent healthcare utilization.

Method
Procedure and participants
Forty-six per cent (n = 8113) of the Berkshire West GP patient population (Jamie, 2013) who
had T2DM, from 21 Berkshire surgeries, were sent a letter inviting them to take part in research
in managing low mood and worry (from March 2012 to June 2013), being run across Berkshire
West. In the letter, individuals were informed that if they took part in the research, they would
be allocated to either a group who received an intervention that had been modified, or to a
standard group (control condition). 199 individuals contacted the IAPT service by telephone
and were booked for a telephone triage with a practitioner who had been specifically trained in
helping clients to think about links between low mood and worry, and difficulties with managing
T2DM. In order to be eligible to take part in the research, individuals were required to have
diagnosis of T2DM, presenting with symptoms consistent with depression or anxiety, or both,
as indicated by either PHQ-9 score of 10 or above, or GAD-7 score of 8 or above, and a clinical
assessment that indicated a presentation of depression or anxiety. Potential participants were
excluded if their goals for therapy were not related to an improvement in depression or anxiety,
e.g. those looking for more information on management of diabetes. Potential participants were
excluded if their presentation was not suitable for primary care mental health services, e.g.
those in receipt of secondary care mental health services. Out of the 199 people who attended

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 CBT and physical health conditions 133

Figure 1. (Colour online) Flowchart indicating method of recruitment

the telephone triage, 140 people were invited to take part in the research, with the remaining
59 people presenting with specific reasons for not taking part (see Fig. 1).
After triage and opting to take part in the research, participants were allocated to control
condition (n = 67) or diabetes specific treatment condition (n = 73). The project was divided
into five cohorts over a period of 10 months, with each cohort consisting of both a control group
and diabetes specific treatment group that were run in parallel, and matched overall by location
and time of day. After the triage, once participants had opted to take part in the research and

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 134 A. L. Wroe et al.

Figure 2. (Colour online) Graphs to show changes in self-management of diabetes in the control condition
and diabetes specific treatment condition (of individuals who completed both pre- and post-measures)

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 CBT and physical health conditions 135

gave verbal consent, they were asked to note the days, times of day and locations that they
could attend sessions. The dates of the intervention and control groups had been pre-arranged,
and the practitioner offering triage was aware of these dates and locations, but not aware which
groups were the experimental condition and which were control condition. The participant’s
name was added to the group that suited them. When there was more than one group that
suited their needs, the allocation was determined by block size such that individuals were
allocated to the group with fewer people. The allocation procedure included randomization at
this point such that if there was no difference, the name is randomly allocated to either group
on a random 1 in 2 basis. The participants were not informed as to whether they had been
allocated to intervention or control group.
Following verbal consent before allocation of the group course, participants gave written
consent to take part in the research after the group was allocated (participants were not aware of
the condition at this point). A proportion of the participants were invited, but did not attend any
sessions of the groups (15 in the control group and 10 in the intervention group), leaving a total
of 52 who attended control group sessions and 63 who attended sessions in diabetes specific
treatment condition group (ratio 1:1.2). Based on previous research (Wroe et al., 2015), which
found a change in depression and anxiety with an effect size of 0.69 and 0.84 respectively, a
sample size of 35 per group would provide a significant effect in terms of primary outcome of
depression and anxiety. Based on findings of that study around glycaemic control, with an effect
size of 0.63, a sample size of 50 participants would be required to obtain significant change
from pre- to post-intervention. Participants were sent questionnaires 3 months after their group
was completed. Follow-up data were obtained for 56 individuals (24 in the condition and 32
in the diabetes specific treatment condition). The remaining 60 participants who attended the
groups either did not return follow-up questionnaires or declined providing further feedback.

Measures
Primary outcome measures were around depression and anxiety. The PHQ-9 (Kroenke et al.,
2001) was selected to measure symptoms of depression, and GAD-7 (Spitzer et al., 2006) was
used to measures symptoms of anxiety. Both measures were obtained every session as is routine
practice in the service, in order to have a minimum of outcome measures for individuals who
did not attend every session. Reliable improvement was assessed using Jacobson and Truax’s
(1991) reliable change criteria. The measure of reliability used for the PHQ-9 and the GAD-7
was Cronbach’s α, taken from the validation studies of the measures (Kroenke et al., 2001;
Spitzer et al., 2006). To be considered reliable, pre–post change on the PHQ-9 needed to exceed
5.55, and on the GAD-7 the comparable value was 4.02.
Secondary outcomes included measures of management of T2DM, firstly using a self-report
scale, ‘Disinhibited Eating, and Summary of Diabetes Self-Care Activities’ questionnaire
(SDSCA) (Toobert et al., 2000). This asks about that person’s recommended regimens, and
then measures the numbers of days per week that the person adheres to a range of aspects of
potential regimen, if that aspect has been recommended for that individual person: general diet
(a healthy eating plan), specific diet (a diet high in fruit and vegetables and low in high-fat
foods), exercise, blood sugar testing, medication and foot care. This measure was obtained
only in the first and last session, as it was deemed too time consuming to complete every
session, raising concerns about potential burden on participants. It is therefore only available
as an outcome measure for individuals who attended the first and the last session of the groups.

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 136 A. L. Wroe et al.

As objective measures of T2DM management, secondary outcome measures included

physiological measures such as glycosylated haemoglobin (HbA1c) measured by international
federation of clinical chemistry standard (IFCC) measures of mmol/mol. HbA1C is the
indicator for the last three months glycaemic control and the main predictor of diabetic
complications. The reporting method was standardized and adopted during this study in 2012
and as such the latest international standard was used throughout converting old previous
measures. As patients are sometimes tested only every 6–12 months by their GP, and due to
the mandatory 3-month time lag between making any changes to diabetes management and
changes in HbA1c measures, any readings obtained between 3 and 9 months after the end
of the group were used. If there was more than one reading within this time frame, the first
measure was used.
Secondary outcome included adjustment, which was measured by the Work and Social
Adjustment Scale (WSAS) (Mundt et al., 2002). This was used every session as a measure
of the adjustment in relation to work, home management, social leisure, private leisure and
personal/family relationships.
Finally, secondary outcome measures included healthcare utilization, which was recorded
as standard for every patient treated by the NHS, and includes planned hospital admissions,
planned hospital out-patient appointments, unplanned emergency admissions, and Accident
and Emergency attendance. The database was accessed via the health informatics department
to obtain costs 0–6 months pre-group, and 6–12 months post-group.
The measures (PHQ, GAD, SDSCA and WSAS) were repeated 3 months after the end of
the group.

Statistical analyses
The data were analysed using SPSS (version 13.0) with an a priori alpha level of 0.05 used
for all statistical tests. Missing data were imputed using expected means, if data were found to
be missing at random [using MCAR (missing completely at random) test]. Repeated measures
analyses of variance were conducted for measures that met the criteria for parametric tests
(normal distribution which was not skewed), to test the difference between the modified group
and control group. Any interaction was further analysed using t-tests and paired t-tests. All
measures met the test for normality apart from SDSCA frequency of taking medication, in
which case non-parametric tests were conducted (Wilcoxon signed rank test). Due to the
skewness of the post-groupHbA1c measures, these scores were transformed using a log
transformation, which resulted in a normal distribution that was not skewed. These data were
then analysed using paired t-tests.

Intervention
Individuals with T2DM were invited to attend a ‘Wellbeing Group’ focusing on low mood
and worries. The groups ran weekly for 6 weeks (1.5 hours per session), with the number
of people invited to each group ranging from 6 to 12. All groups were run by Step 2 IAPT
practitioners who were skilled in running standard Wellbeing Groups that have shown to be
effective regarding mood (PHQ and GAD) and adjustment (WSAS). The modifications in the
diabetes specific treatment condition were based on the findings from the pilot study (Wroe
et al., 2015), and remained within the boundaries of IAPT Step 2 interventions, focusing on goal

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 CBT and physical health conditions 137

setting, behavioural activation, problem solving, cognitive restructuring, exposure therapy and
sleep hygiene. The practitioners running the diabetes specific treatment group had training from
a specialist clinical health psychologist and GP on working with T2DM, and received weekly
clinical health psychology supervision. In total, 10 therapists delivered the interventions, with
four therapists delivering the control groups and six therapists delivering the experimental
groups. The reason for six therapists delivering the experimental group was because of therapist
availability, with one of the therapists working part time. All six therapists were Psychological
Wellbeing Practitioners (PWPs) with similarities in level of experience in both the experimental
and control group. Each group had two PWPs with significant experience post-qualification
(more than 2 years). The main adaptations were in the areas of engagement and the ‘language’
of the work. Practitioners who ran the diabetes specific treatment groups were trained in health
psychology models (Leventhal et al., 1997) in order to help them think about illness beliefs,
and were also trained in using socratic questioning as opposed to didactic teaching, as is more
commonly used in the standard wellbeing groups. This was selected as an additional technique
necessary in this intervention, based on findings from the service development phase of this
work (Wroe et al., 2015). It was suggested that this technique supported clients in moving
from exploring their experiences of living with T2DM to identifying thoughts, feelings and
behaviours that are relevant to their maintaining cycles of low mood or anxiety, and therefore
to help participants develop their own idiosyncratic understanding of the link between their
mood and T2DM management.
The research followed the procedure approved by The National Research Ethics Service
(NRES) Southampton A 12SC0103 initially for one year and granted a further year’s extension
for follow-up. Potential harm of the intervention was not assessed systematically. However,
risk issues were monitored as a standard part of the service. As is standard in the service,
individuals were contacted between sessions if they scored 2 or more on item 9 of the PHQ-9
(which asks about thoughts of harming oneself) to assess and monitor risk. The research was
funded by the Department of Health, executed through the National IAPT Team.

Results
There were no significant differences in age or in scores. Pre-group measures also showed no
differences between conditions (see Table 1).
In the control condition, 37 people (71.2%) attended at least four sessions. This was
comparable to the diabetes specific treatment condition in which 42 people (66.7%) attended at
least four sessions. As PHQ, GAD and WSAS are obtained every session, these are available
for all clients; all participants who attended any sessions were therefore included in these
analyses. For clients who did not attend sessions 1or 6, pre- or post-group measures of the
SDSCA are not available.

Measures of mood. There were no significant interactions between time point and
conditions regarding scores on PHQ (F [1,113] = 0.94, p = 0.787) or scores on the GAD
(F [1,113] = 0.39, p = 0.533) (see Table 1). Both measures showed significant main effect of
time (PHQ F [1,113] = 55.32, p < 0.001; GAD F [1,113] = 58.82, p < 0.001), demonstrating
improvements from pre- to post-intervention in both conditions. There was also a main
effect of condition (F [1,113] = 8.66, p = 0.004) for PHQ such that the intervention
condition had higher scores than the control group, and no main effect of condition for GAD

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Table 1. Pre-group measures and condition comparisons include post and follow-up data

138
Diabetes specific condition (n = 63) Comparison, with 95%
Measure Control condition (n = 52) mean [SD] mean [SD] confidence intervals
Age 63.63 [10.71] 63.48 [11.04] t [113] = 0.41, p = 0.681
(n = 52) (n = 63)
Gender 25 male; 27 female 28 male; 35 female Kruskal–Wallis test, p = 0.621
Anti-depressants
Pre-intervention 24 (48%) taking; 26 not taking 34 (57%) taking; 26 not taking χ 2 [1] = 8.22, p = 0.365
Post-intervention 18 (44%) taking; 23 not taking 27 (60%) taking; 18 not taking χ 2 [1] = 2.229, p = 0.135
PHQ (0–36) n = 52 n = 63 Mean difference (95% CI)
Pre-intervention 10.08 [5.86] 12.86 [5.53] 2.78 (0.67,4.89)
t [113]=2.61, p = 0.010
Post-intervention 6.42 [5.74] 9.46 [6.23] 0.04 (0.80, 5.27)
t [113] = 2.69, p = 0.008

A. L. Wroe et al.
Pre to post difference∗ Paired t [51] = 5.20, p < 0.001 Paired t [62] = 5.33, p < 0.001 χ 2 [1] = 0.07, p = 0.80
Mean difference (95 % CI) 31% met reliable change 40% met reliable change
Follow-up 3.65 (2.24, 5.06) 3.40 (2.12, 4.67)
8.29 [5.62] (n = 24) 8.87 [6.48] (n = 32)
GAD (0–28) n = 52 n = 63 Mean difference (95% CI)
Pre-intervention 7.69 [5.06] 9.86 [4.96] 2.39 (0.53, 4.25)
t [113] = 2.55, p = 0.012
Post-intervention 5.07 [4.63] 7.00 [4.80] 1.93 (0.18, 3.67)
t [113] = 2.17, p = 0.032
Pre to post difference∗ Paired t [51] = 4.74, p < 0.001 Paired t [62] = 6.18, p < 0.001 χ 2 [1] = 0.04, p = 0.83
Mean difference (95 % CI) 35% met reliable change 37% met reliable change
Follow-up 2.61 (1.51, 3.72) 3.08 (2.08, 4.07)
5.50 [4.38] (n = 24) 6.03 [5.62] (n = 32)
WSAS (0–40) n = 52 n = 63 Mean difference (95% CI)
Pre-intervention 12.21 [7.29] 13.87 [7.00] 1.66 (0.95, 4.25)
t [113] = 1.26, p = 0.210
Post-intervention 9.63 [8.18] 11.79 [7.53] 2.15 (0.76, 5.05)
t [113] = –1.47, p = 0.145
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Table 1. Continued
Diabetes specific condition (n = 63) mean Comparison, with 95% confidence
Measure Control condition (n = 52) mean [SD] [SD] intervals

Pre to post difference∗ Paired t [51] = 2.67, p = 0.010 Paired t [62] = 2.72, p = 0.027
Mean difference (95% CI) 2.58 (0.64, 4.52) 2.09 (0.25, 3.92)
Follow-up 10.73 [9.08] (n = 22) 10.84 [10.67] (n = 32)
SDSCA – general diet∗∗ Mean difference (95% CI)
Pre-intervention 4.11 [2.07] (n = 48) 3.96 [2.03] (n = 55) –0.06 (–0.75, 0.64)
t [113] = –0.17, p = 0.87
Post-intervention 3.88 [1.91] (n = 40) 5.01 [1.49] (n = 44) –0.91 (–1.46, –0.35)
t [113] = –3.28, p = 0.001
Pre to post difference∗ Paired t [51] = –0.09, p = 0.925 Paired t [62] = –4.09 p < 0.001

CBT and physical health conditions

Mean difference (95% CI) –0.28 (–0.62, 0.56) –0.88 (–1.30, –0.45)
Follow-up 4.09 [2.02] (n = 22) 5.44 [1.34] (n = 24)
SDSCA – specific diet∗∗ Mean difference (95% CI)
Pre-intervention 3.99 [1.41] (n = 48) 4.01 [1.60] (n = 55) –0.02 (–0.55, 0.21)
t [113] = –0.07, p = 0.948
Post-intervention 3.99 [1.74] (n = 47) 4.88 [1.19] (n = 44) 0.67 (–1.15, –0.19)
t [113] = –2.79, p = 0.006
Pre to post difference∗ Paired t [51]= –0.32, p = 0.75 Paired t [62] = –3.57 p = 0.001
Mean difference (95 % CI) –0.08 (–0.56, 0.41) –0.73 (–1.15, –0.32)
Follow-up 4.27 [1.879] (n = 22) 4.68 [1.69] (n = 25)
SDSCA – exercise∗∗ Mean difference (95% CI)
Pre-intervention 2.42 [2.53] (n = 49) 2.57 [2.11] (n = 54) –0.14 (–0.96, –0.67)
t [113]= –0.35, p = 0.725
Post-intervention 3.01 [2.34] (n = 43) 3.94 [2.26] (n = 44) –0.71 (–1.46, 0.03)
t [113]= –1.90, p = 0.060
Pre to post difference∗ Paired t [51]= –2.10, p = 0.041 Paired t [62]= –4.26, p < 0.001
Mean difference (95% CI) –0.67 (–1.31, –0.03) –1.24 (–1.82, –0.66)
Follow-up 2.57 [2.46] (n = 22) 3.95 [2.29] (n = 22)
SDSCA – checking∗∗ blood Mean difference (95% CI)
Pre-intervention 4.16 [2.70] (n = 32) 3.52 [2.84] (n = 43) 0.44 (–0.41, 1.29)
t [13] = 1.03, p = 0.305
Post-intervention 3.13 [2.67] (n = 31) 5.45 [2.41] (n = 29) –1.38 (–2.10, –0.66)

139
t [113] = –3.80, p < 0.001
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Table 1. Continued

140
Diabetes specific condition (n = 63) mean Comparison, with 95% confidence
Measure Control condition (n = 52) mean [SD] [SD] intervals

Pre to post difference∗ Paired t [51]=1.34, p = 0.185 Paired t [62]= –4.94, p < 0.001
Mean difference (95% CI) 0.53 (–0.26, 1.32) –1.29 (–1.82, –0.77)
Follow-up 2.98 [2.82] (n = 21) 5.97 [1.49] (n = 18)
SDSCA – taking meds∗∗
Pre-intervention 6.73 [1.11] (n = 44) 6.79 [0.61] (n = 52) Mann–Whitney, p = 0.763
Post-intervention 6.76 [0.49] (n = 38) 6.98 [0.16] (n = 41) Mann–Whitney, p = 0.010
Follow-up Wilcoxon test, p = 0.359 Wilcoxon test, p = 0.102
6.89 [0.43] (n = 23) 6.94 [0.22] (n = 25)
SDSCA – checking feet∗∗ Mean difference (95% CI)
Pre-intervention 3.50 [2.57] (n = 45) 2.56 [2.41] (n = 55) 0.81 (–0.05, 1.67)
t [113] = 1.86, p = 0.065
2.38 [2.66] (n = 38) 3.74 [2.42] (n = 43)

A. L. Wroe et al.
Post-intervention –1.05 (–0.26, –0.04)
t [113] = –2.61, p = 0.010
Pre to post difference∗ Paired t [51]=2.73, p = 0.009 Paired t [62]= –3.90, p < 0.001
Mean difference (95 % CI) 0.92 (0.24, 1.60) –0.93 (–1.41, –0.45)
Follow-up 3.25 [2.51] (n = 22) 3.16 [2.35] (n = 25)
HBa1C Transform mean difference (95%
CI)
Pre-intervention 61.86 [14.29] (n = 49) 67.12 [21.02] (n = 50) –0.02 (–0.06, 0.015)
t [113] = –1.21, p = 0.230
Post-intervention 61.58 [14.14] (n = 43) 61.90 [18.27] (n = 49) 0.002 (–0.03, 0.04)
t [113] = 0.08, p = 0.933
Pre to post difference∗ Paired t [51] = 0.29, p = 0.776 Paired t [62] = 3.02, p = 0.004
Transform mean difference (95% CI) 0.003 (–0.19, 0.03) 0.03 (0.01, 0.48)
Healthcare utilization
Pre-intervention £439.63 [£565.76] (n = 32) £728.72 [£1939.01] (n = 39) t [53] = 0.41, p = 0.68
Post-intervention £499.61 [£974.91] (n = 45) £498.78 [£880.73] (n = 48) t [66] = 0.14, p = 0.89
Pre to post difference∗ paired t [20] = 0.03, p = 0.974 (of Paired t [23] = 2.14, p = 0.044
transforms)

∗
Statistical tests of the pre to post difference include imputed data where relevant. The pre and post interventions means shown in the table for each
measure include only participants who completed that measure. ∗∗ Number of days of the week (0–7) this regimen was adopted (if recommended).
 CBT and physical health conditions 141

(p > 0.05). Due to significant pre-intervention differences between the conditions, ANCOVA
was used, demonstrating no effect of condition (PHQ: F [1,114] = 1.72, p = 0.193; GAD:
F [1,114] = 0.37, p = 0.542). There was also no difference between the groups in the proportion
of participants who made a reliable improvements: PHQ (χ 2 [1] = 0.07, p = 0.80); GAD
(χ 2 [1] = 0.04, p = 0.83).
Measure of Work and Social Adjustment. Repeated measures ANOVA for WSAS
demonstrated no significant interaction between time-point and condition (F [1,113] = 0.13,
p = 0.715) and no main effects of condition (p > 0.05), but a main effect of time point
(F [1,113] = 12.13, p < 0.001) due to an improvement in scores in both conditions (see
Table 1).

Self-report measures of Diabetes Management (SDSCA). Data were found to be missing at

random (MCAR test, χ 2 between 28 and 30, p > 0.07 in all cases). Expected neans imputation
process was then used to impute missing data.
(I) Repeated measures ANOVA for general diet demonstrated a significant interaction
between time-point and condition (F [1,113] = 5.68, p = 0.019) (analyses conducted
without imputed data demonstrated significant interaction: F [1,77] = 4.15, p = 0.045).
Post-hoc analyses demonstrated a significant improvement in the diabetes specific
treatment condition and no significant change in the condition (see Fig. 2.1).
(II) Repeated measures ANOVA for specific diet demonstrated a significant interaction
between time-point and condition (F [1,113] = 4.33, p = 0.040) (analyses conducted
without imputed data demonstrated significant interaction: F [1,80] = 4.48, p = 0.037).
Post-hoc analyses demonstrated a significant change improvement in scores in the
diabetes specific treatment condition compared with no significant change in the control
condition (see Fig. 2.2).
(III) Repeated measures ANOVA for frequency of exercise demonstrated no significant
interaction between time-point and condition (F [1,113] = 1.73, p = 0.191) and no
main effect of condition (F [1,113] = 1.70, p = 0.195). However, there is a main
effect of time (F [1,113] = 19.52, p < 0.001) (analyses conducted without imputed
data demonstrated significant interaction: F [1,80] = 1.70, p = 0.195). Paired t-tests
demonstrated significant improvements in both groups (see Fig. 2.3).
(IV) Repeated measures ANOVA for frequency of testing sugar levels demonstrated a
significant interaction between time-point and condition (F [1,113] = 15.73, p < 0.001)
(analyses conducted without imputed data demonstrated significant interaction:
F [1,45] = 9.26, p = 0.004). Post-hoc analyses demonstrated a significant improvement
in the diabetes specific treatment condition and no significant change in the control
condition (see Fig. 2.4).
(V) Wilcoxon signed rank test for frequency of taking medication showed no significant
change in the diabetes specific treatment condition (p = 0.359) or control condition
(p = 0.102).
(VI) Repeated measures ANOVA for frequency of checking feet demonstrated a significant
interaction between time-point and condition (F [1,113] = 21.02, p < 0.001)
(analyses conducted without imputed data demonstrated significant interaction:
F [1,71] = 6.25, p = 0.015). Post-hoc analyses demonstrated a significant improvement
in the intervention condition and no change in the control condition (see Fig. 2.5).

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 142 A. L. Wroe et al.

Glycaemic control. Due to skewed data, the HbA1c scores were transformed using a
log transformation. Using imputed data for missing variable, repeated measures ANOVA
demonstrated a non-significant interaction between time-point and condition (F [1,113] = 3.02,
p = 0.085) (analyses conducted without imputed data demonstrated significant interaction:
F [1,90] = 5.08, p = 0.027). Post-hoc analyses demonstrated significant improvements in the
diabetes specific treatment condition and no significant change in the control condition (see
Table 1).
Healthcare utilisation. Due to failure to meet tests of normality and skewness, scores were
transformed using log 10. Missing data were not imputed due to a high proportion of missing
data (38% of pre-data). Repeated measures ANOVA demonstrated no significant interaction
between condition and time point (F [1, 42] = 2.52, p = 0.119) and no main effects of time
(F [1,43] = 2.39, p = 0.130) or of condition (F [1,42] = 0.24, p = 0.624). Exploratory analyses
were conducted to investigate this further, and whilst there was no change in costings of the
control group (t < 1), there was a non-significant reduction in costings of the intervention group
(t [23] = 2.14, p = 0.054) from £728.72 in the 6 months before the group was conducted, to
£498.78 during the period 6–12 months after the group was conducted.
Follow-up measures. Follow-up measures were obtained (n = 56, 49%) 3 months after
the groups were completed. Of these, 24 were in the control condition and 32 in the diabetes
specific treatment condition. Due to high frequency of missing data, this was not imputed. In
the control condition, there were significant improvement from pre to follow-up measures of
PHQ-9 (t [21] = –2.79, p = 0.010) and GAD-7 (t [23] = 3.14, p = 0.005), and no significant
differences in other measures. In the intervention group, there were significant improvements
from pre to follow-up measures in PHQ-9 (t [31] = 3.47, p = 0.002), GAD-7 (t [31] = 3.99,
p < 0.001) general diet (t [23] = –3.71, p = 0.001), exercise (t [21] = 3.56, p = 0.046) and
frequency of checking blood sugars (t [17] = –3.51, p < 0.001), and no changes in other
measures (see Table 1).

Discussion
Whilst both the standard control group and the modified intervention were effective in
improving mood scores, and work and social adjustment, results demonstrate that the modified
intervention is more effective with regard to the management of T2DM, compared with the
control group. This finding is consistent between self-report measures of T2DM management
and the objective measures of glycaemic control measured 3–9 months following the end
of treatment. Findings also suggest a trend in terms of benefits in terms of the secondary
(hospital related) care costs. However, the sample size is small. Furthermore, improvements in
mood and management of T2DM in terms of general diet, exercise and frequency of checking
blood sugar levels were maintained at the 3-month follow-up for the modified group. The
proportion of participants in the current research who met reliable change on measures of
mood is comparable to the proportions found across the National Health Service (Gyani et al.,
2013). However, the standard interventions are not effective in terms of improving management
of T2DM. In order to show improvement regarding such measures, as well as improvement
in glycaemic control, it was necessary to modify the intervention with specialist input and
regular supervision, namely a GP and clinical health psychologist, so that it was specifically
tailored to T2DM and its management. This is consistent with recent work by Roth and Pilling

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 CBT and physical health conditions 143

(2015) stating specific competences required when working psychologically with people with
physical health conditions.
These findings are key given the expansion in UK primary care (IAPT) services to work
with people with long-term physical illness (Department of Health, 2011). If such services
are to offer effective interventions, it is necessary to understand the specific competences
required to work psychologically with such clients, without which it is unlikely that clients
will engage with therapy (Wroe et al., 2015), and as demonstrated in this work, will not
benefit in terms of improved management of the condition. The facilitators (practitioners)
developed these additional competences by attending teaching sessions from a GP on T2DM
and its management, and attending clinical skills training and supervision from a clinical
health psychologist around engagement, the role of illness beliefs, the use of socratic
questioning, and an ability to help clients understand the link between mood and management of
their T2DM.
A strength of the study is the way the intervention was run in an IAPT setting, which means
that it can be generalized to other IAPT services. Practitioners in this study were invited to
attend weekly supervision as frequently as possible dependent on their heavy workload and
work schedule. Furthermore, although continuity of care was provided when possible, some
groups did not have the same facilitator at each session. Sessions in the intervention group
were always covered by a practitioner who was ‘upskilled’ and running other intervention
groups. Likewise, sessions in the control group were covered by practitioner who was not
‘upskilled’. The potential impact of this was not measured. These challenges were felt to be
typical of a busy IAPT setting, and so realistic issues that would need to be taken into account
when considering the results found in this study. Furthermore the intervention is generalizable
to other IAPT service in that the modified intervention stayed within the boundaries of Step
2 IAPT interventions for mild to moderate anxiety/depression in line with NICE guidelines
(NICE, 2009a,b; NICE, 2011a,b), which was a key objective for this study. Another strength
of the study is that scores on the PHQ, GAD and WSAS were obtained every session. This
ensured that outcome variables were available for all clients, even if they did not attend the
final session.
It is worth noting a potential limitation of the findings of this study. Participants entered the
service following the standard procedure, and were then flagged to have a ‘modified’ diabetes
triage. Although the triage was the same format and length as a standard triage, it was modified
in a way that was found to be helpful in the previous research in terms of engagement and
attendance of sessions (Wroe et al., 2015) and was conducted by an ‘up-skilled’ practitioner
who introduced the concept of linking mood with management of T2DM. It is interesting to
note that, in the current research, the attendance rates were no different between the modified
group and the control group. This is not consistent with previous findings (Wroe et al., 2015).
It is likely that the engagement process started at the point of triage, such that the findings of
the control condition may be improved compared with a protocol in which the standard triage
was offered. In both groups, about 70% of participants attended at least four sessions. This
figure is comparable to previous findings in a general IAPT service. For example, in the IAPT
demonstration site in Doncaster, Clark et al. (2009) found that of those offered low-intensity
treatments for depression and anxiety, 34% dropped out of treatment or discontinued. It would
be helpful in future research to allocate individuals to conditions before triage.
A further limitation is around the allocation process. The process was as close to
randomization as possible, within the limitation of the service set up. This meant that people

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 144 A. L. Wroe et al.

were allocated to condition based on suitability of groups on the basis of time and location,
and on size of groups, and only if there were still options at that point, on 1 in 2 randomization.
The participants were not aware, at that point, as to whether the group course was intervention
or control. However, once the group course commenced, it is likely that they could make
assumptions based on the content of the group course.
It is also worth noting that there may be differences between the groups based on particular
therapists; therapists completed either modified intervention or standard intervention, and
therefore the groups were facilitated by different individuals. This protocol was used as it was
judged that it would be difficult for upskilled practitioners to stick to the standard intervention.
Several therapists conducted group courses in each condition, thus diluting the effects of any
potential individual differences. Furthermore, the therapist competence was not measured.
Adherence to the protocol and relevant adaptations was also not systematically assessed.
However, this was discussed regularly in supervision.
It is not possible to know whether changes may have been due to changes in anti-
depressant medication. However, this possibility was limited by the use of the control condition.
Furthermore, there were no differences in the start of therapy or post-intervention in the
proportions of individuals in each condition who were taking anti-depressant medication.
The findings regarding healthcare usage are limited. It may be that modified psychological
interventions that support patients in terms of depression and anxiety and management of
their T2DM, could also reduce healthcare usage. It is likely that a larger sample is required
to demonstrate any effect, and a longer follow-up period. A previous study, investigating
the healthcare effectiveness of a depression intervention run by specialist nurses, with 329
participants, found savings of $1100 per person in the period up to 24 months after therapy
began (Simon et al., 2007). The findings are limited and further research is required to
evaluate this. Analysis of the cost of psychological therapy compared with any savings to other
healthcare costs is required to support arguments that psychological therapy for people with
long-term physical illness offers an economic benefit through reduction of physical healthcare
usage (Layard and Clark, 2014).
These findings lend some support to the argument that psychological work focusing
specifically on depression and anxiety may be effective regarding diabetes management
(e.g. Lamers et al., 2011; Snoek et al., 2008), but with the pre-requisite that interventions
focusing on depression and anxiety are tailored to the T2DM and its management, and that
the facilitators are skilled in competences around working with T2DM, as well as in focusing
on depression and anxiety. Based on the competency framework (Roth and Pilling, 2015)
which states the importance of engagement, role of illness beliefs, and importance of the link
between depression/anxiety and conditions management, it is possible that the adaptations
noted in this research are necessary in offering interventions focusing on depression and
anxiety in the context of long-term physical illnesses, and further research is required to address
this.
The main question addressed by this paper is whether evidence-based IAPT interventions
for the treatment of mild to moderate depression and anxiety can be effective for people
with long-term physical illness in terms of both mood and condition management. These
findings support previous research (Wroe et al., 2015, pp. 424) suggesting that in order for
standard psychological interventions to be effective, ‘adaptations need to be made such that the
interventions are specifically tailored to the condition in question, with practitioners attending
specific training in working with people with long-term physical illness and with input from

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 CBT and physical health conditions 145

health professionals with expertise in the medical condition, in this case a GP and a specialist
clinical health psychologist.’

Acknowledgements
The authors would like to thank all of the clients who attended the groups, and their invaluable
feedback. Special thanks are due to the five participating Berkshire general practices (Theale,
Milman Road, Potteries Tilehurst, Brookside and Parkside surgeries) who allowed their patients
to be written to and invited, as well as providing sites from which the groups ran.
Financial support: The research was funded by the Department of Health, executed through
the National IAPT Team.
Ethical statement: The research followed procedures approved by the National Research Ethics
Service (NRES) Southampton A 12SC0103, initially for one year and granted a further year’s
extension for follow-up.
Conflicts of interest: Abigail L. Wroe, Edward W. Rennie, S. Solesse, J. Chapman and A. Hassy
have no conflicts of interest with respect to this publication.

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