Web-based cognitive behaviour therapy for depression in adults with Type 1 or Type 2 diabetes Kim van Bastelaar
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Web-based cognitive behaviour therapy for depression in adults with Type 1 or Type 2 diabetes
Kim van Bastelaar
Web based cognitive behaviour therapy for depression inadults with Type 1 r Type 2 diabeteso
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Contents
PageHAPTER 1C 11
CHAPTER 2 21
Published in BMC Psychiatry; 2008 February; 8:9
31CHAPTER 3
Published in Diabetic Medicine; 2010 July;27(7):798 803
CHAPTER 4 39
Published in Patient Education and Counseling; 2010 July;7
CHAPTER 5 51
Published in Diabetes Care; 2010 February;34(2):320 325
CHAPTER 6 61
Submitted for publication
CHAPTER 7 73
Summary 83Nederlandse samenvatting 85References 88Dankwoord 105
General Introduction
CHAPTER 1 11
CHAPTER 1
General Introduction
CHAPTER 1 12
Importance of this thesis
BackgroundDiabetes
Global burden of diabetes
,
General Introduction
CHAPTER 1 13
Treatment of diabetes
,
,
Psychosocial aspects in the treatment of diabetes
CHAPTER 1 14
Emotional distress diabetesof
,
Depression
,
General Introduction
CHAPTER 1 15
Global burden of depression
Treatment of depression
,
adversityconsequences beliefs
,
,
,
CHAPTER 1 16
Diabetes and depression
First
Figure 1
second hypothesisFigure 1
1diabetes depression
2
Fig .ure 1
third hypothesis
33 commonfactor
Figure 12
General Introduction
CHAPTER 1 17
Consequences of depression in diabetes outcomes
, ,
Recognition and referral of depression in diabetes patients
Treatment of depression in diabetes
,
d dd
, ,
,
CHAPTER 1 18
Web based therapy
,
eHealth in Diabetes
,
,
,
Aim and outline of this thesis
,
The main aim of this thesis is to study the effectiveness of this web basedCognitive Behavioural Therapeutic (CBT) depression intervention in adults withtype 1 or type 2 diabetes.
General Introduction
CHAPTER 1 19
Chapter 2
Chapter 3
question 1Chapter 4
question 2 question 3 Chapter 5
question 4 Chapter 6
question 5 Chapter 7
CHAPTER 2
Web based cognitive behavioural therapy (W CBT) for diabetespatients with co morbid depression:
Design of a randomised controlled trial
BMC Psychiatry
CHAPTER 2 22
AbstractBackground
Research design and methods
Discussion
Study design
CHAPTER 2 23
Background
,
,
,
,
Aims of the Trial
CHAPTER 2 24
Research design andmethodsStudy Design
Figure 1
Study procedures
Treatment allocation
Recruitment
Study population
Study design
CHAPTER 2 25
Figure 1.
CHAPTER 2 26
Description of interventions Intervention group Patient enrolment will occur individually on a continuous basis, i.e. at any point in time during the study period. The number of included participants is not limited by physical capacity other than the number of coaches available. After inclusion criteria are met and the patient has returned the informed consent s/he will be randomly assigned to the intervention or the control group.
Patients assigned to the intervention group will receive a password per e‐mail with wh cich they an log in to the course. They will be instructed (and reminded per e‐mail) to complete one session per week, during 8 consecutive weeks.
Coaches will send e‐mails to participants as a way to encourage them to continue their efforts. Such reinforcement should help to keep patients on track with the course and lower the risk of drop‐out. They also provide the participants with eedback on their homework assignments. It is clearly stated that coaches will not give dvice on personal issues. fa Control group Control group patients will receive an e‐mail in which they are informed of the randomisation result, which means they will start the course after 12 weeks. To reduce the risk of loss of interest; participants placed on the waiting‐list will automatically receive weekly protocollised e‐mails with motivating, positive feedback to enforce them to remain involved in the study.
After eight weeks they are invited per e‐mail to fill in the questionnaires again. Twelve weeks after randomization patients will undergo a second screening (using the CES‐D‐score ≥ 16 as a first screener for depression and additionally the CIDI interview) to confirm depression. If still eligible, the patient is invited to follow the course. Patients, who do not qualify, i.e. show (spontaneous) remission, are excluded at this point. Patients who developed suicidal ideation during the 12 weeks waiting period, are offered the opportunity to have an appointment with a diabetes psychologist of the VU
oUniversity Medical Centre r a colleague nearby in case the distance from the participant's home to the VUMC should be problematic. The effectiveness of the intervention is determined directly after completing the web‐based intervention up till 6 months follow‐up (see Consort flow chart in Figure 1).
If the depression has deteriorated at the end of the course, as indicated by the scores of the CES‐D, a consultation with a diabetes psychologist at the VU Medical entre is offered to the patient. In agreement with their General Practitioner a decision ill be made about further treatment or hospitalization.
Cw Intervention development and trial design The Dutch version of the manual‐based self‐help course named 'Coping with Depression' ('In de put, uit de put') has been adapted as web‐based intervention ('Kleur je Leven').49, 130 This intervention has been adjusted further by our team to fit the needs of patients with diabetes ('Diabetergestemd'). Based on our research, clinical experience and input from an expert panel of diabetes patients, the following topics were incorporated: managing 'poor' test results, uncertainty about blood glucose fluctuations and negative emotions, communication with health care professionals, talking about diabetes with others, the burden of daily self‐management, and coping with diabetes‐related worries (e.g. about hypoglycaemia and late complications). The course consists of 8 consecutive weekly lessons. The course will provide information, practice examples, exercises/self‐tests and homework assignments. The web‐based course is delivered on an individual basis. Patients weekly receive (protocollized)
Study design
CHAPTER 2 27
Outcome AssessmentPrimary outcome measures
Secondary outcomemeasures
Covariates
Statistical Analyses
.134
CHAPTER 2 28
Power calculation
DiscussionStrengths and limitations
Study design
, ,
CHAPTER 2 29
Future implementation
CHAPTER 3
Diabetes specific emotional distress mediates the associationbetween depressive symptoms and glycaemic control
in Type 1 and Type 2 diabetes
iabet MedD
CHAPTER 3 32
AbstractObjectives
Research design and methods
Results nn
P
Conclusions
Mediation diabetes distress
CHAPTER 3 33
Introduction
,
,
,
Research design andmethods
Assessmen of depression symptoms with the CES Dt
CHAPTER 3 34
Assessment of diabetes specific emotional distress with the PAID
Glycaemic control
Statistical analysis
tP
ResultsBaseline characteristics
P n = Table 1
n
n =
Mediation diabetes distress
CHAPTER 3 35
Table 1.Totaln = 627
Depr S D16 n 2%)
essed CE3= 202 (
Non de CES D< 16 n 8%)
pressed6= 425 (
Pvalue
FemaleAge (years)Married/partnerNative DutchLow education*BMIType 2 diabetesInsulin therapy inType 2 diabetes†HbA1cDiabetes duration (years)‡Type 1Type 2Diabetes complicationsRetinopathy§NeuropathyNephropathy§Diabetic foot§Erectiledysfunction**Co morbidityCardiovasculardisease§PAID totalDepressiontreatment
in pastn
n n n n n
PP
PP
Depression, diabetes related emotional distress and glycaemic control
P
n =
n =Table 2
CHAPTER 3 6
Table 2.
3
Depression CES D 16n = 202 (32%)
No depression CES D < 16n = 425 (68%)
Characteristic No elevateddiabetesrelated
distress PAID< 40
Elevateddiabetesrelated
distress PAID40
No elevateddiabetesrelated
distress PAID< 40
Elevateddiabetesrelated
di Dstress PAI40
P value
n =
P
The mediating effect of distress in the relation between depression andglycaemic control
P RP RP R
P =P R Table 3
Z P
Mediation diabetes distress
Table 3.
CHAPTER 3 37
Complete study population (n = 627)Coefficient
(B)95% CI P
valueR2
Post hoc analysis: the odds for poor glycaemic control in subgroups of patients
P Table 2
n =n =
n =n =
Conclusions
CHAPTER 3 38
, ,
net al
, ,
,
CHAPTER 4
Development and reach of a web based cognitive behaviouraltherapy programme to reduce symptoms of depression and
diabetes specific distress
Patient Educ Couns
CHAPTER 4 40
AbstractObjectives
Methods
Results
Conclusion
Practice implications
Development and Reach
CHAPTER 4 41
Introduction
,
,
,
,
, ,
,
,
,
,
,
CHAPTER 4 42
,
MethodsDevelopment of the diabetes specific depression in erventiont
Studying the effectiveness of the intervention: eligibility and recruitment
Development and Reach
CHAPTER 4 43
MeasuresSocio demographics and clinical characteristics
Depression
,
Diabetes specific emotional distress (PAID)
Statistical analyses
CHAPTER 4 44
ResultsThe diabetes specific depression intervention
Table 1
Table 1.
Lesson Topic in generic web baseddepression CBT
Diabetes specific topic added
1
2
3
4
5
6
7
8
Development and Reach
Figure 1
Figure 1.
CHAPTER 4 45
CHAPTER 4 46
Reach
Characteristics participants
Table 2
Reasons for choosing a web based diabetes specific depression intervention
Development and Rea
able 2.
ch
CHAPTER 4 47
TTotal,n = 255
Discussion and conclusionDiscussion
CHAPTER 4 48
Conclusion
Development and Reach
CHAPTER 4 49
Practice implications
CHAPTER 5
Web based depression treatment for Type 1 and Type 2 diabeticpatients: A randomized, controlled trial
iabetes CareD
CHAPTER 5 52
AbstractObjective
Research design and methods
ResultsP = d P
P d PP
P
Conclusions
RCT
53
Introduction
CHAPTER 5
Design overview
,
,
Research design andmethods
Figure 1
CHAPTER 5 54
Setting and Participants
Randomization
In erventio sWeb based Cognitive Behavioral Therapyt n
Waiting list
RCT
CHAPTER 5 55
n
igure 1.F
MeasurementsBaseline measures
Diagnostic and Statistical Manual for Mental Disorders
Outcomes
n
n
nn
n n
n
nn
nn
n n
CHAPTER 5 56
,
Sample size calculation
Statistical analysis
t
dd
d = d d
RCT
CHAPTER 5 57
ResultsRandomization and study attrition
P =P
P Figure 1
P
Baseline characteristics
Table 1
n = n =n = n =
Change in depressive symptoms
P <d
Secondary outcomesP <
P
P
Clinically significant improvement
PP
CHAPTER 5 58
Table 1.
P
Per protocol analyses
CharacteristicsAll
patients(n = 255)
CBTparticipants(n = 25)1
Waiting listControl
participants*(n = 130)
yn (%)n (%)
n (%)n (%)
)n (%
n (%)units / wk
n (%)
yn (%)
y
%n (%)
n (%))n (%
RCT
CHAPTER 5 59
P
dd
n= n =
P
Conclusions
, ,
CHAPTER 5 60
,
CHAPTER 6
Is a severe clinical profile an effect modifier in web based diabetesspecific depression treatment?
Secondary analyses from a randomized controlled trial.
Submitted for publication.
CHAPTER 6 62
AbstractBackground
Objective
Methods
Results
Conclusions
Effect-modification
CHAPTER 6 63
Introduction
,
dd
d
,
,
, ,
CHAPTER 6 64
,
MethodsParticipants and procedure
n
n =n =
Intervention
Effect-modification
CHAPTER 6 65
Sample characteristics
P
Outcomemeasure
Potential effect modifiers
Potential effect modifiers
CHAPTER 6 66
Statistical analyses
ResultsBaseline characteristics
Table 1
Potential effect modifiersTable 1 n
nn n
n n Table 2
nP
P n
PP n
n
PP
nP
PP
P
Effect-modifi
Table 1.
cation
CHAPTER 6 67
C risticsharacte All pati = 255)ents (nSocio demographics
yn
nn
n
C haracteristicslinical c
n%
n
Dep esn
D s sive Disorder (WHO CIDiagnosi r I)
Diagnosis Anxiety disorder, n (%)
CHAPTER 6 68
Table 2. The amount of the study population that suffers from a diagnosed depression, a diagnosed anxiety disorder and elevated diabetes‐specific emotional distress (PAID >40).
Data are presented as number (percentage of total stud of n = 255). DD indicates Data Major Depressive Disorder (measu the WHO CIDI); Anxiety isorder (WHO CIDI); diabetes distress, elevated diabetes‐specific emotional distress (PAID >40)
y sample red with M Anxiety,
d
Study population n = 255
Diabetes specific emoti tress
onal dis
No diabetesspecific emotio stress nal di
MDD Anxiety 146 (57) 69 (27)
Anxie46 (18) 23 (9)
No ty No MDD
77 (30) Anxiety
34 (13) 43 (17)
109 (43) 26 (10) Anxie
17 (7) 9 (4) No ty 83 (33) 30 (12)
127 (50) 53 (21) 128 (50) Total
Table 3. Comparing the effectiveness of a web‐based diabetes‐specific depression therapy on symptoms of depression (CES‐D), testing effect modification by depression status (MDD versus o MDD), anxiety disorder (yes/no), or high level of diabetes‐specific emotional distress yes/no). n(
Data are given as mean (SD). CBT indicates cognitive behavioral therapy condition; WL, waiting – list control condition; CES‐D, Centre for Epidemiologic Studies‐Depression scale; MDD, Major Depressive Disorder.
CESD score Pre treatment
Post treatment
Onemonth followup
P – value
Intention to treat Analyses n = 125 / 130
CBT WL CBT WL CBT WL
MDD 30 (7) 30 (7) 21 (11) 24 (9) 20 (12) 24 (10) .489 No MDD 27 (7)
26 (7)
18 (9)
21 (8)
19 (10)
20 (8)
25 (10)
.706 Anxiety disorder (CIDI)
32 (7) 31 (8) 23 (11) 25 (9) 22 (11)
No anxiety disorder 27 (7)
31 (7)
26 (6)
31 (8)
19 (10)
22 (11)
21 (8)
24 (9)
19 (11)
21 (12)
21 (8)
24 (9)
.924 Elevated diabetes specific emotional distress (PAID ≥ 40) No elevated diabetes specific emotional distress (PAID >40)
26 (7) 26 (6) 18 (10) 22 (9) 18 (10) 21 (9)
Both MDD and Anxiety disorder are diagnosed using the WHO CIDI, World Health Organization Composite International Diagnostic Interview. Our statistical tests relied on generalized estimating equation (GEE) analyses. P‐values indicate level of significance of effect‐modification. All analyses are adjusted for baseline CES‐D scores, aseline between‐group differences on socio‐demographic variables, and differences in time etween pretreatment and post treatment. Table represents uncorrected data. bb
Effect-modification
69
Potential effect modifiers in of the treatment effectP
Table 3
CHAPTER 6
P Table 3
PTable 3
Discussion
N
CHAPTER 6 70
,
Conclusions
Effect-modification
CHAPTER 6 71
General Discussion
CHAPTER 7 73
CHAPTER 7
General Discussion
CHAPTER 7 74
Importance of this thesis
Figure 1
Figure 1.
Figure 2
General Discussion
ER 7 75
igure 2.F
Conclusions of this thesis
chapter2 chapter 4
chapter 5
“A web based CBT depression intervention is effective in reducingdepressive symptoms in type 1 and type 2 adult diabetes patients whowere suffering from subclinical depression or major depressive disorder,with a moderately high significant effect size (d = 0.29 in intention totreat analysis and d = 0.70 in per protocol analysis).”
CHAPT
chapter 6
chapter 3
The results of the studies which are presented in this thesis and the literature described in this thesis, lead toward a model which explains the potential mechanism behind a beneficial impact of diabetes‐specific depression treatment with CBT in the case of diabetes, which is presented in Figure 3. This model explains that web‐based diabetes‐specific CBT treatment (via the CBT skills: cognitive restructuring, behavioural reinforcement, social skills, relaxation) leads towards improved mood and behaviour (presented in the left box), mutually impacting each other. Behavioural improvements and the reduction in diabetes‐specific emotional distress lead towards improved glycaemic control and overall improved physical health (presented in the middle box). These somatic improvements lead towards a prevention of the onset of diabetes complications, while the skills learned in the CBT leads toward a prevention of depression recurrence (presented in the upper right box). Finally the model shows that CBT, via emotional improvements, improved physical health and prevention of depression, complication and comorbidity adds to an improved current and future quality o life (presented in the bottom right box). f
CHAPTER 7 76
igure 3. Model explaining the mechanism behind the beneficial impact of CBT on mental and hysical health in the case of depression and diabetes Fp Methodological considerations In interpreting the findings of this study, we should acknowledge several strengths and imitations of the study. In the following sections the methodological considerations of he randomised controlled trial will be discussed. lt Adjustments to the protocol Before t ur he start of the study, we first described the way we planned to conduct orandomised controlled trial (chapter 2). Two adjustments were made to this protocol.
A clear distinction should be kept in mind between elevated symptoms of depression (subclinical depression) and a diagnosed depressive disorder (MDD, major depressive disorder). At the start of the study, we planned to include patients with MDD only. However, during recruitment, we noticed that a substantial part of the patients who signed up for the study suffered from subclinical depression, and not MDD. Due to inclusion reasons we therefore chose to make our inclusion criteria less strict and to include patients with sub threshold depression.
Prevention of depression recurrence
Web‐based diabetes‐specific CBT treatment
Improved physical health
Decreased onset of complications and
comorbidity (e.g. cardio‐vascular diseases) Improved glycaemic
control
Behavioural improvement (e.g. diabetes self‐care,
lifestyle)
Improved quality of life:
Emotional improvement: Current and future
Diabetes‐specific
Emotional improvement: Generic
General Discussion
CHAPTER 7 77
External validity
Self enrolment
chapter 4
Characteristics of study sample
Diagnostic validityWeb based administration of questionnaires
CHAPTER 7 78
Validity of questionnaires in diabetes patients
Study design
Internal validity
Confounding
Successful randomisation
Attrition
Sample size
General Discussion
n =
n =
CHAPTER 7
Clinical implicationsEffect size
dd
d
79
n =
Clinical relevance
chapter 5
Ethical considerations
CHAPTER 7 80
Drop out
Diabetes outcomeschapter 5
chapter 3
Type of diabetes
General Discussion
CHAPTER 7 81
Future directions
chapter 3
CHAPTER 7 82
ImplementationReferral
Embedment in routine care
Concluding
83
Chapter 3
Summary
Web based cognitive behaviour thera y for depression inpadults with Type 1 or Type 2 diabetes
Chapter 1
Chapter 2
84
Chapter 4
Chapter 5
P dP P d
PP
P
Chapter 6
Chapter 7
85
Hoofdstuk 3
Nederlandse samenvatting
Cognitieve gedragstherapie via het internet voor depressie involwassenen 2met diabetes type 1 of type
Hoofdstuk 1
Hoofdstuk 2
86
Hoofdstuk 4
Hoofdstuk 5
P dP P
d P
P P
Hoofdstuk 6
Nederlandse samenvatting
87
oofdstuk 7
88
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