The goal of this research project is to evaluate effectiveness of a cognitive behavioural therapy self-help intervention offered through the Internet in multiple sclerosis (MS) patients with a co-morbid depressive symptoms. With the online guided…
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Source
Brief title
Condition
- Central nervous system infections and inflammations
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect measurements will be taken at 0 weeks (first measurement) and upon
conclusion of the treatment at five weeks, 4 months, 10 moths follow-up
(post-tests). All measurement scales have shown to be reliable, valid and
responsive, and have been widely used as an outcome measure in MS research
and/or research on psychiatric conditions. Participants who score above the
cut-off score of 20 on the BDI are invited for a structured clinical interview
for depression and anxiety disorders (the World Health Organization's Composite
International Diagnostic Interview; WHO CIDI, 1990). The CIDI interview is
conducted by telephone, as well as the Percieved Need of Care Questionnaire
(PNCQ) and the Expanded Disability Status Scale (EDSS). The PNCQ assesses the
participants' perceptions of their needs for mental health care and the meeting
of those needs.
Interview (post-test, only for respondents participating in the MRI-study):
Depression section of the structured clinical interview for presence of
depression disorder and suicidal ideation (World Health Organiszation (WHO)
version 2.1). The CIDI establishes diagnoses according to the Diagnostic and
Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (28). The CIDI
interview is conducted by telephone
Primary outcome measure is the Beck Depression Inventory (BDI-II). The BDI is a
self-report instrument for assessing the existence and severity of depressive
symptoms (Beck et al. 1961). Each of the 21 items match a symptom of depression
according to the DSM-IV (DSM-IV, 1994). The total score is calculated by adding
all the items and lies in between 0 and 63. The sum of the scores indicates the
severity of the depression. Scores of 0 to 13 represent minimal depressive
symptoms, scores from 14 to 19 indicate mild depression, scores from 20 to 28
moderate depression and scores of 29 to 63 indicate severe depression.
Secondary outcome
Secondary outcomes include other measures of depression, problem solving
skills, quality of life, well-being, disability level, social support, mastery,
cognitive functioning, fatigue, anxiety and satisfaction.
For comparison with the data of the Netherlands Study of Depression and Anxiety
(NESDA) we decided to use another instrument to assess depressive symptoms. The
Inventory of Depressive Symptomatology (IDS) consists of 28 questions, to
assess the severity of depressive symptoms (Rush et al. 1996). The IDS assess
all the criterion symptom domains designated by the American Psychiatry
Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition
(DSM-IV) (APA 1994) to diagnose a major depressive episode.
The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report
inventory that is used for measuring the severity of an individual's anxiety
(Beck et al. 1988). We also use the HADS (Zigmond & Snaith, 1983) to measure
anxiety and depressive symptoms.
The EuroQol (Dolan, 1997) consists of the EQ-5D and EQ-VAS. The EQ-5D describes
quality of life on 5 dimensions: mobility, self care, daily activities (work,
study, etc.), pain or other symptoms and anxiety / depression. Each dimension
consists of 3 possible answer categories: no problems, some problems, serious
problems. The EQ-VAS is a scale from 0 to 100 on which the patient indicates
how well they perceive their current health situation, where 0 is the worst
possible health state and 100 the best imaginable health state.
The MSIS-29 (Hobert et al, 2001) is used to measure the impact of MS en de
WHO-5 (Bech, 2004) for measuring well-being.
The Fatigue Severity Scale (FSS) (Krupp et al. 1989) is a 9-item scale, used to
assess the severity of fatigue. The Multiple Sclerosis neuropsychological
questionnaire (MSNQ) is a self-report screening that is used to measure of
neuropsychological functioning in MS (Benedict et al. 2003). Three subscales
of the Social Problem Solving Inventory - Revised (SPSI-R) are used to
determine individual problem-solving skills (SPSI-R, D*Zurilla et al. 2002).
Mastery is measured with the Mastery Scale (Pearlin et al. 1978). The Social
Support Inventory (Stansfeld and Marmot, 1992) contains questions on details
about social support from the four most intimate persons. Finally, the Client
Satisfaction Questionnaire (CSQ-8) measures patient satisfaction with the
intervention (de Brey, 1983).
Neuropsychological examination: an adapted version of the Brief Repeatable
Battery of Neuropsychological Tests (BRB-N) will be performed in order to
accurately measure cognitive function. Neuroimaging: the main MRI read-out
parameters are: whole-brain resting state functional connectivity and
activation patterns of the amygdala during an emotional memory task.
Additionally, conventional imaging metrics will be obtained, such as total
brain volume, lesion volume, the number of cortical lesions and white matter
integrity. In order to obtain these measures, the following MRI sequences will
be scanned on a 3T MRI scanner (total scanning time is approximately 60
minutes):
* T1 weighted: measurement of *black-hole* volume (neuronal loss)
* T2/PD weighted: measurement of white matter lesion volume
* MPRAGE: volumetric brain measurements (white, grey and total brain volume)
and registration for fMRI measurements.
* Resting state fMRI: measurement for functional connectivity of the whole
brain and regions of interest (e.g., amygdala)
* Task-specific fMRI: during an emotional memory task brain activation will be
measured (i.e., to investigate changes in amygdala activation patterns)
* Diffusion tensor imaging: integrity of white matter fibre bundles
* Double inversion recovery: number of (sub)cortical grey matter lesions
Background summary
Depressive symptoms are prevalent among persons with Multiple Sclerosis.
Lifetime prevalence-rates of depression in MS ranges from 28-51%, compared to
10-15 % in the general population. However, depression is often not recognized
in MS, patients do not seek treatment for depression and adequate treatment
tends to be lacking. Depression is related to poorer quality of life, disrupts
social support and has been associated with fatigue, a decrease in working
hours and cognitive impairment in MS-patients.
Effectiveness studies have shown that MS patients are receptive to treatment
for their depressive episodes. Recently web-based self-help treatment has been
demonstrated as an effective intervention for reducing depressive symptoms in
patients with a depressive disorder. We expect it to be a promising approach to
the treatment of co-morbid depression in MS patients, because it is easy
accessible and can overcome disease-related barriers to participate in
face-to-face counselling.
A pilot study has shown promising results (NL25173.029.08, 2008/92). The
preliminary pilot findings presume that the web-based intervention is a
feasible and effective treatment for depressive symptoms in MS. These findings
strongly encourage us to proceed with this intervention, and to examine the
effectiveness of this web-based self-help course for the treatment of
depressive symptoms in MS in a randomized clinical trial. To the best of our
knowledge, this will be the first randomized controlled study to evaluate
effectiveness of a web-based self-help treatment in MS.
Study objective
The goal of this research project is to evaluate effectiveness of a cognitive
behavioural therapy self-help intervention offered through the Internet in
multiple sclerosis (MS) patients with a co-morbid depressive symptoms. With the
online guided self-help Cognitive behaviour therapy (CBT) intervention we want
to improve the level of care for people with MS and co-morbid depression. By
recruiting and offering treatment through the Internet we can reach a group of
underserved patients who normally do not seek or receive treatment for
distress.
The aims of this study are twofold: 1) examine the effectiveness of the
web-based CBT self-help intervention for MS-patients with depressive symptoms,
and 2) compare characteristics of symptoms of depression and anxiety, quality
of life, social support, perceived need of care and mastery in MS patients with
co-morbid depression versus a cohort of patients with current depression.
Using the results of the RCT, we will address the following:
1. Is the web-based self-help intervention (cognitive behaviour therapy based
on the principles of problem solving therapy) more effective in reducing
depressive symptoms in MS patients than care as usual?
2. What are the effects of the web-based intervention at issue on anxiety,
social support, cognitive functioning, quality of life, well-being, disability
level and fatigue in MS patients with depressive symptoms?
3. Which predictors of a favourable outcome of the web-based intervention on
depressive symptoms can be identified?
By comparing the RCT data with a large-scale available depression cohort from
the Netherlands Depression and Anxiety Study (NESDA):
4. Is there a difference in presentation of depressive symptoms in people with
MS, compared to persons with a current depressive disorder (and no MS) and
chronically ill with a co-morbid depressive disorder?
Neurobiological mechanisms underlying the positive effects of web-based
self-help therapy
5) Does web-based self-help therapy to relieve depressive
symptoms in MS patients alter resting state functional brain networks, as
measured with functional magnetic resonance imaging (fMRI)?
6) What is the effect of web-based self-help therapy in patients
with MS on the functional connectivity between the amygdala (important brain
structure involved in depression) and other brain regions?
7) Does web-based self-help therapy in people with MS affect
brain activation patterns of the amygdala during an emotional memory task
(task-specific fMRI)?
Study design
The study is designed as a randomized clinical trial with 1 intervention arm
and a care as usual control group. 166 MS patients with moderate to severe
depressive symptoms will be randomly assigned to a treatment group or a
care-as-usual control group. The treatment group will follow the web-based
self-help intervention of 5 weeks. Outcome is evaluated before and after the
intervention, at 4 and 10 months follow-up (only the intervention group to
investigate the effects at longer term).
In case not all required 30 of the 166 included respondents completed the
baseline and posttest of the neuropsychological testing and MRI scanning
section of the study, we will continue this part of the randomized controlled
trial until we included 30 respondents who are willing to participate in the
neuropsychological testing and MRI scanning at baseline and post-assessment. In
that case, respondents can only participate in the study if they agree with MRI
and neuropsychological testing. Follow-up assessments (4 and 10 months) will be
cancelled. (protocol page 6, 19)
The present study has been developed in collaboration with the Netherlands
Study of Depression and Anxiety (NESDA; www.nesda.nl). NESDA is an ongoing
cohort study designed to investigate the course and consequences of depressive
and anxiety disorders. A detailed description of the NESDA study design and
sampling procedures can be found elsewhere (Penninx, B. W., et al. The
Netherlands Study of Depression and Anxiety (NESDA): rationale, objectives and
methods. Int J. Methods Psychiatr Res 17, 121-140, 2008).
This third aim, to investigate the effect of online intervention on advanced
neuroimaging parameters (functional networks and brain activation patterns) and
cognitive function, will be investigated with our colleagues: Prof. dr. J.
Geurts, Prof. dr. F. Barkhof, drs H. Hulst from the department of Neurosciences
and Radiology.
Intervention
The online cognitive-behavioural self-help treatment examined in this study is
based on what is known as *problem-solving therapy* (PST). The original
PST-based intervention for depression is extensively described by Cuijpers, van
Straten, Warmerdam (2007). With a number of modifications we adjusted the
intervention for people with MS and co-morbid depression, conserving the intent
of the PST-based intervention. Modifications concerned additional information
about MS and its psychosocial consequences and text and examples applying to MS
patients. The intervention is called *minderzorgen*: (website:
www.minderzorgen.nu)
The web-based intervention is a self-help intervention of five modules with
text, exercises, and figures. The participants access the intervention from
their personal computers via the Internet. The recommended time for completion
of the course is five weeks, one session per week. Participants are asked to
work on their assignments for at least 2 hours per week. In that period,
respondents describe what they think is important in their lives, make a list
of their problems and concerns, and divide these into three categories:
unimportant problems (problems which are not related to what is important in
their life), important and solvable (these are solved through a six-step
procedure of problem-solving), and important but unsolvable (such as loosing
someone through death; for each of these problems the respondent makes a plan
how to cope with this). The six-step problem-solving method is the most
important step of the intervention containing the following steps: (1) write a
clear definition of the problem, (2) generate multiple solutions to the
problem, (3) select the best solution, (4) work out a systematic plan for this
solution, (5) carry out the solution, and (6) evaluate as to whether the
solution has resolved the problem. Support during the intervention consists of
communication through brief, weekly e-mails sent through the website, and will
be provided by supervised clinical psychology Master students. The e-mail
correspondence is intended to facilitate the patient*s effective use of the
self-help method, and is explicitly not intended to build up a patient *
therapist relationship. During the intervention, patients will receive four
supportive text-messages (sms) per week on their mobile phone to support them
during the intervention and to enhance compliance rate. Patients could not
react on the text-messages.
Care as usual consists of the care provided by the health care centre visited
by the patient. We will not intervene in the given care, and the patient is
free to accept any intervention (medication, psychological treatment) given in
the time period of the study. The received mental health care will be
registered. If proven successful, we will provide the care as usual control
group the intervention on voluntary basis after the study has been finalized.
Study burden and risks
The burden of participation will be 4 hours of extra work, next to the
intervention (14 hours). These 4 hours consist of:
-screening questionnaire (5-10 minutes)
-interview by telephone (45 minutes)
-pre-test: several questionnaires (45 minutes)
-3 x post-test: several questionnaires (45 minutes) (in case we included 166
patients but continue the study to include all the 30 patients for the MRI part
of the study, two post-test will be cancelled (2 x 45 minutes)
-MRI-measurement/neupsychological testing/post-CIDI interview will take 5 hours
(extra: 2 x 2,5 hours).
Participation in this study is without any risks
Oldenaller 1
Amsterdam 1081 HL
NL
Oldenaller 1
Amsterdam 1081 HL
NL
Listed location countries
Age
Inclusion criteria
MS patients (minimum age 18) can take part if they: 1) are diganosed with MS 3
months befor the screening and 2) are able to manage the Dutch language.
Inclusion criteria for the intervention are: 1) a minimum score of 20 on the
Beck Depression Inventory (BDI-II), and the intention and capability to invest
5 weeks of their time to follow a selfhelp intervention through the internet.
Exclusion criteria
No access to Internet or no email-address, no experience with Internet, no
sufficient command of Dutch, unable to read, current use of antidepressants or
other treatment of depression, current suicidal ideation.
Subjects with contra-indications for MRI scanning or from Belgium will be
excluded for the MRI study (see Onderzoeksprotocol, appendix 6, checklist MRI).
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 | NL35191.029.11 |