J Behav Med
DOI 10.1007/s10865-012-9451-z
Effects of a cognitive behavioural treatment in patients with type 2
diabetes when added to managed care; a randomised controlled
trial
Laura M. C. Welschen Patricia van Oppen
Sandra D. M. Bot Piet J. Kostense
Jacqueline M. Dekker Giel Nijpels
Received: January 27, 2012 / Accepted: July 30, 2012
Springer Science+Business Media, LLC 2012
Abstract Effects of a cognitive behavioural treatment
(CBT) in type 2 diabetes patients were studied in a ran-
domised controlled trial. Patients were recruited from a
diabetes care system (DCS). The intervention group
(n = 76) received managed care from the DCS and CBT.
The control group (n = 78) received managed care only.
Effects on risk of developing coronary heart disease (CHD),
clinical characteristics, lifestyle, determinants of behaviour
change, quality of life, and depression were assessed after 6
and 12 months. The intervention did not result in a signifi-
cant reduction of CHD risk (difference between intervention
and control group was -0.32 % (95 % CI: -2.27; 1.63). The
amount of heavy physical activity increased significantly in
the intervention group at 6 months [intervention versus
control group was 20.14 min/day (95 % CI: 4.6; 35.70)].
Quality of life and level of depression improved as well. All
effects disappeared after 6 months. No effects were found on
clinical characteristics.
L. M. C. Welschen (&)
P. van Oppen

S. D. M. Bot
G. Nijpels
Department of General Practice, EMGO Institute for Health and
Care Research, VU University Medical Center, Van der
Boechorststraat 7, 1081 BT Amsterdam, The Netherlands
e-mail: lmcwelschen@hotmail.com
S. D. M. Bot
P. J. Kostense
J. M. Dekker
Department of Epidemiology and Biostatistics, EMGO Institute
for Health and Care Research, VU University Medical Center,
Amsterdam, The Netherlands
P. van Oppen
Department of Psychiatry, EMGO Institute for Health and Care
Research, VU University Medical Center, Amsterdam,
The Netherlands
Keywords Type 2 diabetes
Lifestyle intervention

Cognitive behavioural treatment
Cardiovascular disease
risk
Randomised controlled trial
Introduction
Behavioural interventions focused on lifestyle in patients
with type 2 diabetes (T2DM) have shown to be effective in
improvements of clinical outcomes. (Ismail et al., 2004;
Norris et al., 2004). It is still unclear what kind of inter-
vention is most effective (Ismail et al., 2004), but it is
generally acknowledged that a behavioural intervention
should be based on a theoretical framework (Norris et al.,
2001; Peyrot & Rubin, 2007; Hardeman et al., 2005) and
that such interventions should focus on the increase of self-
management of the patient (Glasgow et al., 2004; Peyrot &
Rubin, 2007).
In order to improve patients clinical characteristics and
finally the 10-year risk of a coronary heart disease (CHD),
we have added a cognitive behavioural treatment (CBT),
which has been supported in the literature to facilitate
behaviour change, to the standard diabetes care (Spahn
et al., 2010).
The CBT was guided by techniques of Problem Solving
Treatment (PST), a practical skill building treatment
(DZurilla & Nezu, 2001; Mynors-Wallis, 2005). PST is
focused to teach patients to use their own skills to resolve
problems and improve their symptoms, a key element for
successful self-management of diabetes (Franke et al.,
2007; Glasgow et al., 2004).
We hypothesized that PST might increase patients
attitude, social influences and self-efficacy, according to
the theoretical framework of the Attitude, Social influences
and self-Efficacy model (ASE-model) which attribute to a
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patients intention to change behaviour, resulting in
improvement of patients characteristics and in a reduction
of CHD risk (Brug et al., 1995). The intervention aimed to
increase physical activity, change eating behaviour and/or
quit smoking. It is believed that this contributes to a more
likely increase in self-management of patients than an
intervention focused on one domain, because patients are
encouraged to make choices (Clark et al., 2004). In contrast
to other studies this theoretical driven study was imple-
mented in clinical care and patients were allowed to choose
the behaviour they wanted to change.
The present study describes the effects of adding a CBT
aimed at changing lifestyle for T2DM patients on the
estimated risk of developing a CHD event in the next
10 years (Stevens et al., 2001). Effects on lifestyle,
patients clinical characteristics, and determinants of
behaviour change were also assessed. In addition, we
compared quality of life, and the level of depression
between the intervention and control group.
Methods
Study design
A randomised controlled trial was conducted with T2DM
patients that were included in the Diabetes Care System
(DCS), a disease management system in the Netherlands
(Welschen et al., 2006). The design of the study has been
described in detail previously (Welschen et al., 2007).
Patients were invited from 13 general practices partici-
pating in the DCS for a recruitment visit by means of an
invitation letter, including information on the study. The
inclusion period lasted for 1 year. Patients were considered
eligible for the study based on the following inclusion cri-
teria: 1875 years old; able to understand the Dutch lan-
guage; at high risk of developing cardiovascular disease and
diabetes complications (HbA1c C 52 mmol/mol (7.0 %)
and/or body-mass index C 27.0 kg/m2 and/or smoking).
Eligible patients were randomised at an individual level into
an intervention and a control group by means of block ran-
domization within general practices, to avoid contamination
of the intervention by the general practitioner. Randomisa-
tion was performed by a manager of the DCS, not involved in
the patients care by means of a list drawn up by a computer
program (Random Allocation Software version 1.0.0).
Patients, diabetes nurses and dieticians could not be blinded
to the intervention. Study participants were seen by different
diabetes nurses and dieticians if in control or intervention
group. The medical assistants had contact with the patients
only prior to randomisation and were not involved in the
intervention. Therefore for them it was not necessary to be
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blinded. The principal investigator remains blinded during
the entire intervention. All participating patients gave their
written informed consent. The Medical Ethics Committee of
the VU University Medical Center in Amsterdam approved
the study design.
Control group
The control group received the managed diabetes care from
the DCS. The diabetes care in the DCS is organized in
yearly assessments consisting of a measurement visit fol-
lowed by a visit to a dietician and a diabetes nurse in order
to receive information and education. A standardized pro-
tocol according to the Guidelines of the Dutch College of
General Practitioners was used (Bouma et al., 2006).
Intervention group
The intervention group was planned to receive 36 CBT
sessions of 30 min, which was dependent on the need of
the patient. During the first session, the most important
behavioural domain was assessed by the diabetes nurse.
The intervention was transmitted to a dietician if the
component was related to dietary intake. In case of
smoking or physical activity, a diabetes nurse continued
with the intervention. During all sessions, PST was used to
set achievable goals for behaviour change. PST consists of
several steps including: problem definition, goal setting,
generating a solution, implementing the solution, and
evaluation of the outcome of the implementation (Mynors-
Wallis, 2005).
The dieticians (n = 6) and diabetes nurses (n = 4) had
received a training in performing the CBT of 2 days, fol-
lowed by two instruction days on how to implement the
intervention in the DCS. A treatment manual was used
during the intervention. In addition, all sessions were tape
recorded in order to be able to assess treatment fidelity.
Each 4 weeks, a supervision meeting, guided by a spe-
cialized CBT psychologist (PvO), was organized.
Measurements
Outcome measurements were extracted from self-reported
questionnaires and physical examinations.
CHD risk
The 10-year risk of developing a CHD event was calcu-
lated at baseline and at 12 months using the UK Prospec-
tive Diabetes Study (UKPDS) risk engine (Stevens et al.,
2001). Variables included in this algorithm are: age at
diagnosis, duration of diabetes, sex, ethnicity, smoking
J Behav Med
status, systolic blood pressure, HbA1c, total and HDL-
cholesterol.
Clinical characteristics
Measurements were taken at the DCS by research assistants
according to a standardized protocol. Weight and height
were measured while patients were barefoot and wearing
only light clothes. Systolic and diastolic blood pressure
were measured after 5 min of rest in a seated position using
a oscillimetric device (Colin Press Mate BP-8800, Komaki
City, Japan). HbA1c was measured with high performance
liquid chromatography. Fasting plasma glucose was mea-
sured by means of a hexokinase method (Roche Diagnos-
tics GmbH, Mannheim, Germany). Levels of total
cholesterol, high-density lipoprotein (HDL) cholesterol,
and triglycerides were measured using enzymatic tech-
niques (Boehringer-Mannheim, Mannheim, Germany). All
measurements were performed at baseline, after 6 and
12 months, except for total and HDL cholesterol and tri-
glycerides which were only measured at baseline and after
12 months.
Lifestyle: physical activity, eating behaviour and smoking
The SQUASH questionnaire (Short Questionnaire to
Assess Health Enhancing Physical Activity) was used to
assess physical activity (Wendel-Vos et al., 2003). The
total amount of minutes per day that a patient was per-
forming light (24 MET), moderate (46.5 MET), or heavy
physical activity (C6.5 MET) was calculated [MET = unit
of metabolic equivalent, which is the ratio of the energy
cost of a given activity to resting metabolic rate and was
derived from published tables (Ainsworth et al., 2000)].
Eating behaviour was assessed by the Dutch Eating
Behaviour Questionnaire (DEBQ) (Van Strien et al., 1986).
This questionnaire assessed whether a patient is a restraint
eater (overeating after a period of slimming), an external
eater (eating in response to external foot cues), or an
emotional eater (eating in response to emotional arousal
states). Classification into one of these three domains was
achieved by dividing the sum of the corresponding items
for a specific domain by the number of items.
Smoking was assessed as a dichotomous outcome
measure asking if a patient was a smoker or a non-smoker.
Determinants of behaviour change
Determinants of behaviour change were assessed by means
of a questionnaire developed according to the ASE model
(de Vries et al., 1995). There were 3 separate questionnaires
for all 3 behavioural domains (increase physical activity,
eat healthier, and quit smoking), each containing the same
items. There were 5 items concerning attitude, 2 items on
self-efficacy, 2 items on social influences (1 item for
influences from the partner and 1 from friends) and 2 items
on intention to change behaviour. All items were measured
on a 7-point Likert scale.
The mean of the items of each behavioural determinant
was taken as a measure for the specific determinant. Low
scores indicate a positive attitude towards change of
behaviour, a high self-efficacy to perform the behaviour, a
positive social influence from the partner and/or friends,
and a strong intention to change behaviour.
Cronbachs a were all [0.60, indicating sufficient
internal consistency. Except for the Cronbachs a of
smoking (between 0.50 and 0.60).
Quality of life
The EuroQol was used to assess quality of life (Brooks,
1996). This questionnaire consists of a visual analogue
scale on which patients had to indicate their health status
(scale 0100) and five questions on different domains, each
with a scale of three levels: mobility, self-care, usual
activities, pain/discomfort, and anxiety/depression. A mean
weighted health status was calculated with a range of 01.
Depression
An important co-morbidity of patients with diabetes and
also an important covariate in intervention studies is
depression (Lustman & Clouse, 2005). We used the CES-D
(Center for Epidemiological Studies Depression scale) to
assess if depression was present (Radloff, 1977). An
overall score was calculated by summing up all scores,
resulting in an overall score between 0 and 60. A patient
with a score C16 was considered as a possible depressive
case.
Statistical analyses
Two way analyses of variance were used to calculate dif-
ferences in the changes between 06 and 012 months
between the two groups. General practices were added to
the model as a fixed factor, to account for differences
between them. MantelHaenszel statistic was used to
assess differences between the two groups for dichotomous
outcome measures. In additional analyses was adjusted for
age, gender, and diabetes duration. All analyses were
performed according to the intention-to-treat principle.
The following subgroup analyses were performed to
investigate if there were specific patients who would
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Patient 18-75 years old from selected general practices (n=13),

participating in diabetes care system
N = 498

Assessment of eligibility: HbA1c > 52 mmol/mol (7.0%) and/or

BMI > 27.0 kg/m2 and/or patient smokes
N = 421

Eligible: n = 344 Not eligible: n = 77

Written informed No informed consent: N = 190

consent, baseline Refused: n = 150
measurement No time available: n = 23
N = 154 Severe illness/lack of mobility: n = 9
Mental health problems: n = 8

Intervention group: Block randomisation Control group:

n = 76 within GP n = 78

Intervention group: Control group:

N = 72 n = 76
Follow-up 1
Drop-outs: 6 months Drop-outs:
Refused (n=2) Refused (n=1)
Died (n=2) Care at internist (n=1)

Intervention group: Control group:

n = 69 n = 74
Follow-up 2
Drop-outs: 6 months Drop-outs:
Care at internist (n=1) Severe illness (n=1)
Died (n=2) Died (n=1)

Fig. 1 Design of the RCT

benefit from the intervention: high education level (college/
university), per-protocol analysis including patients with
C3 CBT sessions, patients without depression (CES-D
score \ 16).
Missing data were not imputated. P values below 0.05
were considered statistically significant. All statistical
analyses were performed using SPSS for Windows (version
14.0, SPSS Inc., Chicago, IL).
chart showing follow-up of patients can be found in Fig. 1.
The mean amount of CBT sessions patients in the inter-
vention group attended was 3 (SD 1.7).
More men than women were included in both groups
(Table 1). Groups were comparable at baseline. No dif-
ferences were found in characteristics of patients who
dropped out of the study and those who completed the
study.

Results
At baseline, 76 patients were randomised to the interven-
tion group and 78 patients to the control group. A flow
CHD risk
The risk of developing CHD in the next 10 years decreased
from 10.6 to 9.9 % in the intervention group and increased
from 11.1 to 11.2 % in the control group (Table 2). The

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Table 1 Baseline
Intervention group (n = 76) Control group (n = 78)
characteristics
Age (years) 60.5 9.4 61.2 8.8
Gender (% male) 59.5 64.2
Ethnicity (% Caucasian) 97.3 94.9
Marital/cohabiting status (% with partner) 84.8 83.3
Work status (% employed) 30.3 38.2
Level of education (%)
Primary 50 42.9
Secondary 34.8 44.2
College/university 15.2 12.9
Smoking (% smokers) 28.3 23.3
Diabetes duration (years) 7.6 5.0 7.8 6.1
Body-mass index (kg/m2) 31.6 5.7 31.5 5.2
Systolic blood pressure (mmHg) 144.6 20.3 144.6 18.3
Diastolic blood pressure (mmHg) 77.8 7.9 77.0 9.0
HbA1c (mmol/l) 51 11 49 11
HbA1c (%) 6.8 1.0 6.7 1.0
Fasting blood glucose (mmol/l) 7.8 2.2 7.7 1.5
Total cholesterol (mmol/l) 4.4 1.0 4.4 1.0
HDL cholesterol (mmol/l) 1.2 0.3 1.2 0.3
Triglycerides (mmol/l) 1.9 1.1 2.0 1.0
Risk for CVD (%) 10.4 7.4 11.0 8.7
PHQ score depression (% patients)
No depression (score = 0) 19.7 24.2
Minimal (14) 36.1 39.4
Mild (59) 36.1 31.8
Moderate (1014) 4.9 1.5
Moderately severe (1519) 3.3 1.5
Severe (2027) 0 1.5
Data are mean SD, or % of CES-D score C 16 (% depressive patients) 23.4 17.8
patients

difference in change was not statistically significantly behaviour. The percentage of smokers decreased from 25
[95 % BI: -2.27; 1.63]. to 18.3 % in the intervention group, compared with an
increase from 22.4 to 22.9 % in the control group, although
Clinical characteristics this did not reach statistical significance.

Clinical characteristics are shown in Table 2. We only Determinants of behaviour

found small differences between the intervention and the
control group after both 6 and 12 months of follow-up, but
these were considered not of clinical importance.
Lifestyle: physical activity, eating behaviour
and smoking
We found no statistically significant differences between
the two groups on the components of the ASE-model
(Table 3). Self-efficacy to change behaviour was neither
high nor low, in both groups at all time points. Patients did
not have a strong intention to change behaviour, and nei-
ther a weak one.

We found statistically significant differences (Table 3) on Quality of life

heavy physical activity at 6 months but these had disap-
peared at 12 months. There were no statistically significant Quality of life, as measured by the EuroQoL questions,
differences between the three time points on eating improved little in both groups (Table 4). The intervention

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Table 2 Differences in CHD risk and clinical characteristics between patients in the intervention group and the control group at baseline, after 6
and 12 months
Baseline 6 months 12 months P value D 06 months (95 % CI) P value D 012 months (95 % CI)

CHD risk (%, UKPDS risk engine)a

Intervention 10.6 7.2 NA 9.9 5.9 NA P = 0.75 (-2.27; 1.63)
Control 11.1 8.8 NA 11.2 7.0
Weight (kg)a
Intervention 94.4 19.8 95.3 20.8 94.1 22.1 P = 0.78 (-0.90; 1.19) P = 0.73 (-1.33; 0.93)
Control 95.8 17.0 96.0 17.2 95.8 16.6
Body-mass indexa (kg/m2)
Intervention 31.6 5.7 31.8 6.0 31.5 6.1 P = 0.75 (-0.29; 0.40) P = 0.77 (-0.50; 0.37)
Control 31.6 5.2 31.6 5.3 31.8 5.2
Systolic blood pressure (mmHg)a
Intervention 144.5 20.3 143.3 21.3 143.7 19.9 P = 0.53 (-7.08; 3.69) P = 0.80 (-5.89; 4.58)
Control 144.6 18.3 145.1 19.3 142.4 18.0
Diastolic blood pressure (mmHg)a
Intervention 77.8 7.9 75.4 8.2 76.4 9.1 P = 0.08 (-5.50; 0.31) P = 0.22 (-4.22; 0.96)
Control 77.0 9.0 77.0 8.3 77.0 8.3
HbA1c (mmol/mol)a
Intervention 51 11 49 12 51 12 P = 0.65 (-4.27; 2.67) P = 0.71 (-3.55; 2.42)
Control 49 11 50 10 51 10
HbA1c (%)a
Intervention 6.8 1.0 6.7 1.1 6.8 1.1 P = 0.65 (-0.39; 0.24) P = 0.71 (-0.33; 0.22)
Control 6.7 1.0 6.7 0.9 6.8 0.9
Fasting blood glucose (mmol/l)a
Intervention 7.8 2.2 7.9 2.6 8.1 2.2 P = 0.25 (-0.29; 1.11) P = 0.37 (-0.36; 0.97)
Control 7.7 1.5 7.7 1.5 7.6 1.8
Total cholesterol (mmol/l)a
Intervention 4.4 1.0 NA 4.1 0.7 NA P = 0.24 (-0.46; 0.11)
Control 4.4 1.0 NA 4.3 0.9
HDL cholesterol (mmol/l)a
Intervention 1.2 0.3 NA 1.1 0.3 NA P = 0.49 (-0.07; 0.03)
Control 1.2 0.3 NA 1.2 0.3
Triglycerides (mmol/l)a
Intervention 2.0 1.1 NA 1.9 1.3 NA P = 0.55 (-0.45; 0.24)
Control 1.9 0.9 NA 2.0 1.1
Data are mean SD, NA not applicable
a
Two way analysis of variance, adjusted for general practice

group showed a statistically significant increase in quality
of life between baseline and 6 months on the VAS scale,
whereas the control group showed a decrease.
Depression
Between baseline and 6 months of follow-up, we found a
statistically significant difference (P = 0.01) between the
intervention group, in which patients became less depressive,
and the control group, in which patients level of depression
increased (Table 4).
Covariates and subgroups
Age, gender and diabetes duration did not influence the
results (data not shown). In addition, subgroups with either
a high education, or more than 3 CBT sessions, or without
depression did not have better improvements in all outcome

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Table 3 Differences in lifestyle (physical activity, eating behaviour and smoking) and determinants of behaviour change (ASE model: attitude,
social influences and self-efficacy model) between patients in the intervention and control group at baseline, after 6 and 12 months
Baseline 6 months 12 months P value D 06 months (95 % CI) P value D 012 months (95 % CI)

Lifestyle
Physical activity SQUASHa (min/day)d
Light activities
Intervention 104 (38251) 101 (41197) 135 (30291) P = 0.95 (-40.63; 43.45) P = 0.28 (-29.85; 103.15)
Control 135 (0274) 120 (19255) 171 (17332)
Moderate activities
Intervention 40 (17134) 51 (12130) 69 (13171) P = 0.47 (-36.62; 17.03) P = 0.97 (-42.84; 41.45)
Control 41 (1780) 30 (1699) 34 (10151)
Heavy activities
Intervention 17 (046) 23 (055) 29 (079) P = 0.01* (4.6; 35.70) P = 0.38 (-14.73; 36.08)
Control 17 (058) 17 (043) 14 (073)
Eating behaviour DEBQb,d
Emotional
Intervention 1.87 0.90 1.84 0.87 1.82 0.80 P = 0.61 (-0.14; 0.24) P = 0.17 (-0.05; 0.67)
Control 1.82 0.75 1.74 0.81 1.66 0.72
External
Intervention 2.28 0.59 2.19 0.63 2.16 0.64 P = 0.87 (-0.15; 0.13) P = 0.21 (-0.27; 0.06)
Control 2.30 0.58 2.23 0.63 2.22 0.64
Restraint
Intervention 2.87 0.81 2.94 0.81 2.83 0.80 P = 0.59 (-0.15; 0.26) P = 0.25 (-0.33; 0.09)
Control 2.94 0.82 2.95 0.85 2.92 0.83
Smoking (n (%))e
Intervention 17/68 (25 %) 11/60 (18.3 %) 9/62 (14.5 %) P = 0.94 P = 0.96
Control 17/76 (22.4 %) 16/70 (22.9 %) 14/69 (20.3%)
Determinants of behaviour change
ASE physical activityc,d
Attitude
Intervention 2.7 0.2 2.5 0.1 2.6 0.1 P = 0.25 (-0.20; 0.77) P = 0.16 (-0.13; 0.76)
Control 3.1 0.2 2.7 0.1 2.8 0.1
Self-efficacy
Intervention 4.3 0.2 4.4 0.2 4.1 0.2 P = 0.50 (-0.73; 0.36) P = 0.27 (-0.83; 0.24)
Control 4.3 0.2 4.5 0.2 4.3 0.2
Social influences partner
Intervention 2.6 0.2 2.7 0.2 2.7 0.2 P = 0.95 (-0.54; 0.50) P = 0.75 (-0.49; 0.67)
Control 2.8 0.2 2.9 0.2 2.8 0.2
Social influences friends
Intervention 4.3 0.2 4.1 0.2 4.4 0.2 P = 0.57 (-0.64; 0.36) P = 0.10 (-0.83; 0.24)
Control 4.5 0.2 4.4 0.1 4.1 0.1
Intention
Intervention 3.8 0.2 3.7 0.2 4.0 0.2 P = 0.09 (-1.28; 0.09) P = 0.98 (-0.73; 0.75)
Control 4.1 0.2 4.4 0.2 4.2 0.2
ASE dietary intakec,d
Attitude
Intervention 3.3 0.1 3.3 0.1 3.4 0.1 P = 0.29 (-0.52; 0.16) P = 0.72 (-0.51; 0.35)
Control 3.2 0.1 3.4 0.1 3.5 0.1
Self-efficacy
Intervention 4.0 0.3 3.4 0.2 3.9 0.2 P = 0.14 (-1.23; 0.18) P = 0.60 (-1.02; 0.60)
Control 3.6 0.2 3.8 0.2 3.6 0.2

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Table 3 continued
Baseline 6 months 12 months P value D 06 months (95 % CI) P value D 012 months (95 % CI)

Social influences partner

Intervention 3.2 0.3 3.5 0.2 3.0 0.2 P = 0.63 (-0.42; 0.69) P = 0.80 (-0.96; 0.74)
Control 3.4 0.2 3.2 0.2 3.0 0.2
Social influences friends
Intervention 4.6 0.1 4.2 0.1 4.4 0.1 P = 0.72 (-0.41; 0.58) P = 0.42 (-0.25; 0.59)
Control 4.5 0.1 4.3 0.1 4.3 0.1
Intention
Intervention 4.1 0.3 4.3 0.2 4.5 0.2 P = 0.66 (-0.56; 0.88) P = 0.35 (-0.37; 1.05)
Control 4.5 0.3 4.5 0.2 4.6 0.2
ASE Smokingc,d
Attitude
Intervention 3.7 0.4 2.7 0.2 3.2 0.2 P = 0.53 (-0.95; 1.75) P = 0.21 (-0.62; 2.56)
Control 3.4 0.4 2.5 0.2 2.6 0.3
Self-efficacy
Intervention 3.9 0.6 4.0 0.6 4.7 0.6 P = 0.35 (-1.54; 0.58) P = 0.98 (-0.74; 0.76)
Control 5.4 0.4 4.9 0.5 4.9 0.5
Social influences partner
Intervention 2.9 0.5 2.4 0.5 3.3 0.6 P = 0.87 (-1.27; 1.08) P = 0.29 (-0.58; 1.84)
Control 1.7 0.4 1.8 0.5 1.8 0.4
Social influences friends
Intervention 4.9 0.3 4.0 0.4 4.5 0.3 P = 0.78 (-1.53; 2.01) P = 0.92 (-1.40; 1.27)
Control 4.8 0.3 4.3 0.3 4.7 0.3
Intention
Intervention 4.0 0.5 3.8 0.4 4.2 0.6 P = 0.55 (-1.52; 2.75) P = 0.34 (-1.02; 2.79)
Control 4.4 0.4 3.7 0.4 3.7 0.4
* P \ 0.05
a
SQUASH = Short questionnaire to assess health enhancing physical activity. Values are median (interquartile range). Metabolic equivalent of
task (MET) in minutes per day, representing the time engaged in specified physical activities multiplied by the metabolic equivalent value of
each activity. Light activities are rated as 2.0 to \4.0 METs, moderate activities are rated as C4.0 to \6.5 METs, heavy activities are rated as
C6.5 METs
b
DEBQ = Dutch eating behaviour questionnaire. Values are mean SD, measured on a 5-point scale. Higher scores indicate that the patient is
likely to be a emotional, external and/or restraint eater
c
ASE model = Attitude, social influences and self-efficacy model. Values are mean SD, measured on a 7-point scale. Low scores indicate a
positive attitude towards change of behaviour, a high self-efficacy to perform the behaviour, a positive social influence from the partner and/or
friends, and a strong intention to change behaviour
d
Two way analysis of variance, adjusted for general practice
e
MantelHaenszel statistic, adjusted for general practice

measures than patients who did not fulfil any of these
criteria.
Discussion
In the present study, we found that a cognitive behavioural
treatment did not significantly improve CHD risk, when
adding to managed care for T2DM patients. The amount of
heavy physical activity increased significantly in the
intervention group but only on the short term. We found no
significant effects between the two groups on clinical
characteristics and eating behaviour. Quality of life
improved as a result of the intervention, and the level of
depression decreased. The statistically significant effects
all occurred between 0 and 6 months and disappeared
between 6 and 12 months, indicating that the intervention
was not effective on the long term.
This study was implemented in managed care. It is
likely that the diabetes care had already provided adequate
care, with the consequence of a ceiling effect that the CBT
is not of additional value to decrease CVD risk. This is
indicated by the low baseline HbA1c levels of 6.8 % in our
study, compared to HbA1c values of about 8.5 % in other

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Table 4 Differences in quality of life and depression between patients in the intervention and control group at baseline, after 6 and 12 months
Baseline 6 months 12 months P value D 06 months (95 % CI) P value D 012 months (95 % CI)

Quality of lifea
Score EuroQoLd
Intervention 0.71 0.28 0.73 0.27 0.73 0.25 P = 0.45 (-0.05; 0.10) P = 0.40 (-0.04; 0.10)
Control 0.76 0.24 0.77 0.19 0.74 0.25
VAS scale EuroQoLd
Intervention 65.2 18.2 68.4 17.5 65.1 20.5 P = 0.03* (0.54; 11.08) P = 0.59 (-4.65; 8.12)
Control 65.6 18.4 63.6 17.2 61.5 19.2
Depression: CES-Db
Score CES-Dd
Intervention 11.1 8.1 9.9 7.7 11.3 9.9 P = 0.01* (-4.70; -0.81) P = 0.70 (-2.38; 1.60)
Control 9.6 8.2 10.3 8.6 11.0 9.4
Depressive patients (%)c,e
Intervention 23.4 21.7 26.2
Control 17.8 14.9 17.9 P = 0.63 P = 0.90
* P \ 0.05
a
EuroQoL = Values indicate a mean weighted health status SD, with a range of 01. VAS = Visual analogue scale EuroQoL (scale 0100).
Higher scores indicate a more favourable quality of life
b
CES-D = Center for epidemiological studies depression scale. Values are mean SD on a scale of 060. A score C16 indicated depression
c
Depressive patients = score of C16 on the CES-D
d
Two way analysis of variance, adjusted for general practice
e
MantelHaenszel statistic, adjusted for general practice

intervention studies (Steed et al., 2005; Gaede et al., 2003;
Thoolen et al., 2007).
The strengths of our intervention were that (a) it was
theoretically driven by the ASE-model; (b) the key element
was PST which was carefully implemented and controlled
by means of a training for the diabetes nurses and dieti-
cians. We showed that general diabetes health profession-
als are able to acquire psychological skills and incorporate
them into daily health care; (c) the use of a treatment
manual, which encouraged diabetes nurses and dieticians to
give a standardized intervention. Supervision meetings and
tape recordings consolidated this (data not shown).
We found four other similar intervention studies, theo-
retically driven and based on techniques like problem
solving and goal setting. These studies found small effects
on clinical characteristics and often not sustainable on the
long term, like we also found in our study. This might be
due to the general acknowledged issue that behaviour
change is difficult and people are tended to return to their
usual habits and are not able to incorporate new behaviours
in their daily life. However, these studies, as well as a
recent systematic review on lifestyle interventions of
Angermayr et al. (2010) concluded that they may be
effective in reducing severe complications in patients with
T2DM and therefore it is important to continue developing
lifestyle interventions.
This study also had some methodological limitations
that we have to address. Firstly, it is known that people
have the tendency to overestimate physical activity. This
might have happened in both groups but it is likely that
patients in the intervention group, who are encouraged to
change, overestimate physical activity more than patients
in the control group. Secondly, we were not able to find a
validated questionnaire to assess determinants of behav-
iour. A questionnaire was developed by using several
questionnaires of colleagues in the field but we are not able
to say that results were valid. Thirdly, we aimed for 97
patients in each group, but 76 and 78 patients were inclu-
ded in the intervention and control group, respectively.
Fourthly, the mean number of sessions that patients in the
intervention group attended was 3 (SD 1.7), indicating that
not all patients attended the minimal intended number of 3
sessions, probably due to time restrictions of the patients to
attend more sessions or difficulties in maintaining moti-
vated. It is shown that more intensive interventions are
successful in improving CHD risk factors (Alam et al.,
2009). This might be a reason for the small effects that we
found. However, a more intensive intervention would be
even more difficult to incorporate in real diabetes care.
Finally, the baseline CHD risk was relatively low. It is
possible that targeting a higher risk group would have more
effect. However, in that case not many patients would be

123

eligible for this study which would limit the relevance of
this study.
Conclusion
In conclusion, this study showed no overall effect on the
risk of developing CHD, calculated with the UKPDS risk
engine, although it showed improvements in heavy physi-
cal activity, quality of life and depression score at
6 months, but these disappeared by 12 months. We have
provided an extensively described study design and we
hope that the results of our study will not discourage other
researchers to continue performing lifestyle interventions.
Acknowledgments We would like to thank all diabetes nurses,
dieticians, and research assistants that were involved in the study. We
also would like to thank Tootje Hoovers and Jolanda Bosman for
taking care of the organization of the study within the Diabetes Care
System West-Friesland. In addition, we would like to thank Wendy
Hardeman for her comments on the study design during the devel-
opment of the intervention. The study was funded by the EMGO
Institute for Health and Care Research, VU University Medical
Center, Amsterdam, the Netherlands.
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