This cost-effectiveness study will compare blended cognitive behavioral treatment (bCBT) with standard face-to-face CBT (CBT-TAU) among patients with a diagnosis of an anxiety disorder referred to an outpatient specialized mental health care. The…
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Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The health-economic analyses combine clinical outcomes with cost estimates.
Measures of these primary variables are described in this section.
Primary clinical outcomes are 1) Severity of anxiety symptoms measured with the
Beck Anxiety Inventory (BAI), 2) quality-adjusted life years (QALY*s), derived
from the Euro Quality of Life questionnaire (EQ-5D-3L) and health-related
quality of life, tapped by the SF-36 Health Survey.
* Beck Anxiety Inventory (BAI) (Beck et al., 1988)consists of twenty-one
questions about how the subject has been feeling in the last week, expressed as
common symptoms of anxiety (such as numbness and tingling, sweating not due to
heat, and fear of the worst happening). It is designed for an age range of 17*
80 years old. Each question has the same set of four possible answer choices,
which are arranged in columns and are answered by marking the appropriate one
with a cross. The BAI has a maximum score of 63. For this study, treatment
response is defined as a symptom reduction of the baseline BAI symptom severity
score of at least 30% and remission A score reduction of at least 30% reductie
plus a totale score <11.
* EQ-5D-3L (EuroQol Group, 1990; Lamers et al., 2006) will be administered at
every assessment moment (T0-T3) to assess general well-being. The questionnaire
consists of five questions that tap mobility, self-care, daily activities, pain
and mood. Each item has three response categories, ranging from 0 (no problems)
to 3 (severe problems). In addition to this, participants use a VAS scale to
rate their health on a scale ranging from 0 (worst possible health) to 100
(best possible health). The answers on the five questions are combined in a
number sequence that corresponds with the five answers, for example 03210. The
total number of possible sequences is 35=243. Each sequence stands for a
certain health state. On these health states, a value (utility) has been placed
(Lamers et al., 2006), which in turn is used to determine the quality-adjusted
life years (QALYs). This is done by calculating the QALYs gained between the
follow-up periods by weighing the length of time spent in a particular health
condition by the utility score (Drummond & Sculpher, 2005).
*Short Form Health Survey (SF-36) will be used to assess health-related quality
of life (Aaronson et al., 1998; Bech et al., 2003; Ware et al., 2000). This
questionnaire consists of 36 questions that are scored on a 8 multi-item
scales, which assess physical functioning, role limitations caused by physical
health problems, bodily pain, general health perceptions, vitality, social
functioning, role limitations caused by emotional problems and general mental
health. The raw scores are converted to a scale ranging from 0 to 100 with
higher scores being indicative of better levels of functioning. SF-36 scores
will provide a second source to determine QALYS, through the application of the
Brazier algorithm (Brazier, Roberts & Deverill, 2002).
Primary cost outcomes include 1) the costs of offering the treatments and 2)
Patients* out-of-pocket costs (non-medical), such as the costs of travelling to
the health services and the patients* time costs of travelling, waiting and
receiving treatment, which are determined with the standard cost prices as
listed in the pertinent Dutch guideline for economic evaluation (Tan et al.,
2012). Furthermore, 3) Costs stemming from health care uptake, including costs
of medication, and 4) Costs stemming from productivity losses due to
absenteeism and lesser efficiency while at work (presenteeism) are assessed
with The Trimbos/iMTA questionnaire for Costs associated with Psychiatric
Illness (TiC-P; Hakkaart * van Roijen et al., 2002).
*TiC-P is the most widely used health service receipt interview for economic
evaluations in the Netherlands. The TiC-P consists of 46 questions, divided
over two parts. Part 1 entails the health care uptake at relevant health care
providers in the past 4 weeks, such as medication intake, and the number of
contacts within the mental health care setting, with the GP and with other
medical specialists. To determine the costs associated with these contacts, the
care consumption is multiplied by the cost price described in the before
mentioned guideline (Tan et al., 2012). Part 2 of the TiC-P entails loss of
productivity in the past 4 weeks. This is measured by enquiring about the
number of days absent from work and the number of days with reduced efficiency
due to feeling ill. The costs of productivity losses will be based on the
gender and age specific friction costs, as outlined in the Dutch guideline for
costing (Tan et al., 2012).
Secondary outcome
To further evaluate bCBT compared to CBTAU, a number of explorative measures
are administered.
*BDI (Beck Depression Inventory) (Beck et al., 1961) is a 21-question multiple
choice self report inventory of the most widely used instruments for measuring
the severity of depression and assesses presence and severity of depressive
symptoms.
*BSI (Brief Symptom Inventory) (Derogatis and Melisaratos, 1983)is a 53-item,
self-report symptom inventory designed to evaluate general psychopathology. It
is a brief form of the SCL-90 and is designed to provide a multidimensional
symptom measurement in about 10 minutes.
*PDSS (Panic Disorder Severity Scale (PDSS) (Shear et al., 1997) is one tool
that can be used to assess the severity of your panic attacks. The scale is
fairly simple. There are only 7 questions numbered, each one with 5 answers
that can be worth a maximum of 4 points (using 0 to 4 for scoring). That leads
to 28 total points possible with this scale. Any score over 9 is considered
important enough to discuss with a clinical psychologist.
*LSAS (Liebowitz Social Anxiety Scale) originally developed by Liebowitz (1987)
is a short questionnaire to assess the range of social interaction and
performance situations feared by a patient in order to assist in the diagnosis
of social anxiety disorder. The scale features 24 items, 13 relating to
performance anxiety and 11 concerning social situations and has been validated
as a self-report scale (Rytwinski et al., 2009).
*PSWQ (Penn State Worry Questionnaire) (Meyer et al., 1990) is a elf-report
measure to assess pathological worry in GAD patients. By adding up the value
(five-point scale, range 1*5) of all 16 items (e.g., *I*m always worrying about
something*) a score from 16 to 80 can be reached.
*WSAS (Work and Social Adjustment Scale) (Mundt et al., 2002) (is a simple
5-item patient self-report measure, which assesses the impact of a person*s
mental health difficulties on their ability to function in terms of work, home
management, social leisure, private leisure and personal or family
relationships. The WSAS is used for all patients with depression or anxiety as
well as phobic disorders.
Demographic characteristics such as age, sex, education, employment and marital
status will be collected with a general demographic questionnaire. Additional
questions are asked concerning clinical anxiety characteristics such as age of
onset, number of months with anxiety symptoms in past 4 years, duration of
current episode, medical illnesses and treatment status. In addition, patients
indicate their treatment preference (BCBT / CBTAU). Finally, participants are
asked about their computer use: number of hours spent behind a computer and
reasons for use.
Patient evaluations
*CSQ (Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979)) will be
administered at week 64-72 (T3). The CSQ consists of 8 questions with
item-specific response categories. The total score ranges from 8 to 32, with
higher scores being indicative of higher levels of client satisfaction. The
System Usability Scale (SUS, Brooke, 1996) will be administered at week 20
amongst the participants randomized to the bCBT group. The SUS consists of 10
questions with 5 response options, ranging from 0 (strongly disagree) to 4
(strongly agree).The total scores are converted to a scale ranging from 0 to
100. Higher scores are indicative of higher usability of the online platform
that is used for the Internet sessions in the blended therapy. Process data
Data for process analyses are obtained from the administration of the
participating mental health care institutions and through usage statistics of
the online platform. We will consider the aspects that will feed the study flow
chart according to the CONSORT guidelines (Moher et al., 2010; Schulz et al.,
2010), such as the losses and exclusions for each group, with reasons. In
addition to this, we will pay specific attention to: - The extent to which
treatment was provided parallel to bCBT or CBTAU, such as pharmacotherapy, and
the nature of this treatment. - Therapy drop-out (number of completed
sessions); - The total number of face-to-face contacts and cancellations
(amount of therapy received); - Treatment fidelity of both patients and
therapists. In order to measure treatment fidelity of therapists face-to-face
sessions are audio-taped in both treatment groups (when a patient has provided
consent for this). A randomly selected sample of these session-recordings will
be checked for therapist*s treatment integrity by independent raters. In the
bCBT condition the raters also include a random selection of the written
feedback therapists have provided on the online sessions. The sessions
recordings also provide insight in the extent to which patients complied with
making their homework exercises. - Time investment by both the patient and the
therapist. In the bCBT group time investment can be calculated based on the
number of face-to-face contacts and the amount of time spent working with the
online platform. In the CBTAU group time investment will be estimated based on
the number of face-to-face contacts and the treatment fidelity rating. - Time
investment will be discussed in more detail in qualitative interviews for which
we will invite a random selection of 10 patients per treatment group after week
64-72. The interviews focus on the feasibility and usability of the CBT
treatment provided.
Background summary
Anxiety disorders (1 year prevalence 10,1%, incidence 3,1%) are severe
psychiatric disorders associated with a poor quality of life and substantial
economic ramifications (Graaf R de, 2010; RIVM, 2013; Smit et al., 2006). In
the Netherlands, the annual healthcare costs associated with anxiety disorders
are estimated at ¤286 million, 45% (¤128 million) of which is spent on
secondary mental health care, to treat patients with more severe anxiety
disorders. Costs due to absenteeism in anxiety disorders are estimated at ¤998
million per year (RIVM, 2013), exceeding those of depression which are
estimated at ¤467.4 million (GGZNederland, 2010; RIVM, 2013; Smit et al., 2006)
In 2007, the total disease burden caused by anxiety disorders was 202,000
DALY*s in the Netherlands, being third in the top ten list of medical disorders
and having a higher cost impact than depression, diabetes or lung cancer
(RIVM, 2013).
For the above reasons it is of paramount importance to deliver appropriate and
efficient treatment in severe anxiety disorders to decrease the public health
impact of these disorders. Anxiety disorders can be treated effectively with
cognitive-behavioural therapies (CBT), whether or not combined with
pharmacotherapy. CBT is regarded as treatment as usual (TAU) and recommended in
national and international treatment guidelines (NICE; www.ggzrichtlijnen.nl).
It has been shown that anxiety disorder patients in the Netherlands have a
preference for non-pharmacological treatment. In addition, compared with
pharmacotherapy, patients who achieve full remission after treatment with CBT
are less likely to relapse when treatment has stopped (Bruce et al., 2005).
However, less than half of the patients with anxiety disorders receives
appropriate treatment (Bijl et al., 2003), due to anxiety related avoidance
behaviour, stigmatisation, costs, and a perceived lack of availability of
appropriate treatments (Reger and Gahm, 2009).
Internet interventions, especially internet-based cognitive behavioral
treatment (iCBT), are seen as an important strategy for lowering the costs of
the treatment of common mental health disorders (e.g. unipolar depression and
anxiety disorders).
Internet based cognitive behavioural therapy programmes (iCBT) have been
developed for most common anxiety disorders like panic disorder with or without
agoraphobia, social phobia and generalized anxiety disorder, which have proven
to be at least equally effective as face-to-face psychotherapy. Another
advantage of iCBT is that it requires less therapist time and as a consequence
is expected to be less costly than conventional CBT.
Studies show that anxiety treatment delivered via Internet is more effective
than non-intervening and that it can be as effective as face-to-face treatment
(Andersson et al., 2014; Andrews et al., 2010; Cuijpers et al., 2009; Haug et
al., 2012; Lewis et al., 2012; Mayo-Wilson and Montgomery, 2013; Reger and
Gahm, 2009; Spek et al., 2007). Importantly, studies investigating the
cost-effectiveness of Internet-based depression and anxiety treatments suggest
that these may also be more cost-effective than face-to-face treatment, but the
number of studies is still scarce (e.g., (Gerhards et al., 2010; Hedman et al.,
2014; Hedman et al., 2012; Lokkerbol et al., 2014; Nordgren et al., 2014; Smit
et al., 2011; Tyrer et al., 2014; Warmerdam et al., 2010).
Additionally, it should be noted that most study results are obtained among
self-referred depressed individuals from the general population who participate
in standalone Internet treatments (Riper, 2013).
Clinical and economical evaluations of treatment of anxiety via Internet among
patients in routine primary care and specialized mental health care services
are still scarce. A rather new treatment approach combines face-to-face
treatment with Internet sessions into one integrated treatment. This is a
so-called *blended* treatment approach (Riper, 2013). Viewed from a
cost-effectiveness perspective, blended treatment could possibly diminish the
number of face-to-face contacts, increase self-management competencies of
patients and thereby decrease the overall (direct) costs of depression
treatment. This approach could also have a positive effect on waitlist periods,
as therapists can take on more patients, reducing the number of patients that
are waitlisted. Dutch mental health care organizations are ready to implement
blended treatment, and they are motivated to do so by Dutch health policy
makers and insurers (Bakker, 2013), because it is assumed that blended
cognitive behavioural therapy (bCBT) and usual face-to-face CBT (CBT-TAU) are
at least similarly clinically effective, and that bCBT can be offered at lesser
costs. At present, however, little is known about the clinical and
health-economic benefits of blended treatment.
In the current cost-effectiveness study, we will examine health care efficiency
in a randomized controlled trial of bCBT vs. face-to-face CBT (CBT-TAU), among
patients with a diagnosis of with a diagnosis of a severe anxiety disorder like
panic disorder with or without agoraphobia, as social phobia or a generalized
anxiety disorder. The proposed study is one of a series of projects in which we
explore the potential of a *blended cognitive behavioral treatment* (bCBT) for
anxiety and depression.
The study is funded through the healthcare efficiency funding program (Dutch:
doelmatigheidsonderzoek) of the Netherlands Organization for Health Research
and Development (ZonMw). In subprogram 2 of this funding program, ZonMw enables
the investigation of health care efficiency of applied interventions.
The results of this cost-effectiveness study will provide a) insight into the
health-economical outcomes of *blended treatment*, b) indication whether
blended treatment will add value when it is implemented in clinical settings,
and c) insight in whether blended treatment for anxiety is advisable and
feasible from the perspective of various stakeholders.
Study objective
This cost-effectiveness study will compare blended cognitive behavioral
treatment (bCBT) with standard face-to-face CBT (CBT-TAU) among patients with a
diagnosis of an anxiety disorder referred to an outpatient specialized mental
health care. The main goal of the study is to explore the health-economic
outcomes of bCBT in comparison to CBT-TAU, through cost-effectiveness analysis
(CEA), cost-utility analysis (CUA) and a budget impact analysis (BIA), both
from the societal and a healthcare perspective. We assume that bCBT and CBT-TAU
are similarly clinically effective, but that bCBT can be offered at lesser
costs. Hence, we expect health-economic outcomes of bCBT to be favorable in
comparison to those of CBT-TAU. If so, this would justify further large-scale
evaluations and dissemination efforts.
Study design
The study is a cost-effectiveness study, designed as a parallel-group
randomized controlled trial (N = 156), in which participants are randomly
allocated to either bCBT (n=78) or CBTAU (n=78). Participants are recruited in
a Dutch specialized mental healthcare center (GGZInGeest, GGZ
Noord-Holland-Noord, GGZAltrecht or GGZ Oost Brabant), both large scale mental
health service organizations, respectively in the Noord-Holland, Utrecht and
Noord- Brabant region.
Measurements are taken at four fixed 6-10-week intervals (depending on the type
of anxiety treatment); at baseline (T0), week 6-10, week 12-20 and at week 78
(T1 * T3). The recruitment of participants aims to start at 27th of March 2015
(after METC consent) and the last patient follow-up measurement will be
December 2017. The outcomes of our study are to be expected in 2018. For
information on the sample size, see the study protocol.
Intervention
Treatments in both groups are based on CBT and exposure with response
prevention (ERP) protocols for face-to-face treatment of anxiety disorders
according to the Dutch multidisciplinary treatment guidelines for anxiety
disorders (panic disorder with or without agoraphobia, social phobia, and
generalized anxiety). CBT and ERP are the most recommended treatments for
anxiety, according to these guidelines (van Balkom et al, 2013).
The protocols comprise psycho-education (explanation of the treatment rationale
and the general procedures in CBT treatment), cognitive therapy (examining
relation between thoughts, emotions and behavior), a combination of exposure in
vivo with response prevention (ERP; exposure to feared situations combined with
prevention of avoidance behaviour and challenging accompanying catastrophic
expectations, followed by cognitive restructuring). Depending on the type of
disorder all of these components receive more or less attention in the therapy.
In case of comorbidity (ie. depression) or when the initial CBT response is
insufficient, psychotropic drugs are added; including Serotonin reuptake
inhibitors (SSRI's) or as a next step serotonergic Tricyclic Antidepressants.
The last part of the protocol will provide information on relapse prevention
(identifying and adopting techniques/strategies to prevent depressive symptoms
to re-occur). In accordance with standard treatment procedures parallel
treatment (such as medication and/or social skills training) is allowed in both
conditions, if the practitioner deems this warranted.
Face-to-face CBT (CBTAU)
In the CBT-TAU condition, patients receive on average 12-20 45-minutes sessions
of face-to-face CBT, spread out over 12-20 weeks (depending on the type of
anxiety disorder).
In the CBTAU condition, patients receive on average 12-20 45-minutes sessions
of face-to-face CBT, spread out over 12-20 weeks (depending on the type of
anxiety disorder).
Blended CBT (bCBT)
In the bCBT group, patients receive 6-10 face-to-face sessions and 6-10
internet sessions, which will be delivered over a period of 12-20 weeks.
Treatment starts and ends with a face-to-face session. The online sessions are
delivered through a secured web-based online treatment platform (Minddistrict;
www.minddistrict.com). Patients access this platform with a personalized login.
The website offers information that repeats and extends the contents of the
face-to-face sessions. In addition, patients use the website to complete
homework exercises, such as monitoring their activities, feelings, thoughts and
behavior. The first online session focuses on working with the online platform.
The therapist monitors patients* online progress and provides weekly feedback
prior to the next face-to-face session. Face-to-face sessions will be
audio-recorded and checked, following the same procedures as in the CBT-TAU
condition. Online sessions are recorded in the online treatment platform
database. On completion of treatment, patients can still access the online
treatment platform to re-read information and look up homework exercises, such
as the relapse prevention plan.
The same medication regimes will be administered for both conditions throughout
the study. Pharmacotherapy falls under the responsibility of a psychiatrist and
is provided independently of the current study.
Study burden and risks
The blended CBT treatment that will be provided in this trial does not add
risks to the CBT treatment as usual. The questionnaires can be considered a
burden.
van der Boechorststraat 1
Amsterdam 1081 BT
NL
van der Boechorststraat 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of a severe anxiety disorder
Age>18 years
Sufficient command of the Dutch Language Access to the Internet, an e-mail adress and a personal computer (PC) or tablet computer
Willing to be randomised to one of the two treatment conditions
Signed informed consent form
Exclusion criteria
Primary diagnosis of a bipolar, psychotic or substance abuse disorder and/or acute risk of suicide
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51672.029.15 |