Primary Objective: 1.1 Does treatment according to the Dutch EMDR protocol for Urge reduce scratching behavior in AD patients? Hypothesis:1.1 H1: Treatment according to the Dutch EMDR protocol for Body Focused Repetitive Behavior , version…
ID
Source
Brief title
Condition
- Impulse control disorders NEC
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Within a multiple baseline design across subjects, the primary endpoints are
the so called target-measures. These are frequent measures that target the
behavior that is to be altered by the intervention. Within this study, daily
measure is:
Scratching behavior. The frequency and duration of both actual scratching and,
after the start of the treatment also imaginary scratching are measured. These
daily registrations are standardized and are administered automatically via
the mobile phone of participants.
Secondary outcome
Within this study, secondary endpoints are the standardized measures.
Standardized measures are administered to compare study participants to
existing norm groups to see whether the intervention has resulted in clinical
relevant changes. Standardized measures in this study are aimed at 1. Disease
activity, 2. Quality of life and 3. Self-control. These measures are
administered at three timepoints: at baseline (T0), directly after the end of
the treatment phase (T1) and after the last follow-up measurement, that is,
after 6 weeks (T2).
Standardised measures employed in this study are:
Disease activity, measures to be filled out by dermatologist, at T0 and T2
only:
- Eczema Area and Severity Index (EASI). A validated scoring system that grades
the physical signs of atopic dermatitis/eczema. EASI is the core outcome for
measuring the clinical signs of eczema in all trials.
- Investigator*s Global Assessment (IGA) scale. A 5-point tool to measure
disease severity.
Quality of Life, measures to be filled out by the patient at T0, T1 and T2:
- Patient-Oriented Eczema Measure (POEM). The POEM is a Patient-Oriented Eczema
Measure consisting of 7 items to be scored on a 4-point scale.
- SKINDEX-17. The Skindex-17 is a dermatology-specific health-related quality
of life (HRQOL) instrument. It consists of 17 items to be scored on a 5-pointy
scale. The instrument has two subscales: psychosocial impact and impact of
symptoms.
- EQ-5D-5L. The EQ-5D measures health-related quality of life. It is a generic
instrument that can be used in a wide range of health conditions and
treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The
descriptive system comprises five dimensions: mobility, self-care, usual
activities, pain/discomfort and anxiety/depression. The EQ VAS records the
patient*s self-rated health on a vertical visual analogue scale. This can be
used as a quantitative measure of health outcome that reflects the patient*s
own judgement.
Self-Control, measures to be filled out by the patient at T0, T1 and T2.
- Zelfcontrole Cognitie Vragenlijst (ZCCL). The ZCCL is an 11-item self-report
questionnaire with two subscales: importance of positive effect and resistance
difficulty. Each item is scored on a 5-point Likert scale.
Background summary
Atopic eczema, also called atopic dermatitis (AD) occurs in approximately 1 to
10 % of all adults (1, 2). AD is characterized by recurring inflammations of
the skin. AD is nearly always accompanied by itch, which can result in
excessive scratching of the skin, thereby worsening the skin condition. The
symptom of itch has been found to drive the burden of AD. As the itch causes
trouble sleeping, sleeping problems are also quite common in patients with AD
(3). Next to itching and sleeping problems, patients with AD report pain,
anxiety and depression. The disease and the more or less continuous itch
severely impact on patients* daily and working lives, and their health-related
quality of life (3, 4). The itch can drive patients to despair. Case reports
are known from patients who even expressed the clear wish to end their lives
because of the ongoing itch (5). Mental health scores for AD have indeed been
found to be lower than those of other chronic health conditions such as
diabetes and heart diseases (6). AD is typically treated with topical
corticosteroids and emollients. In more severe cases several systemic
treatments are used. Psychological interventions to target the scratching
behavior are described in a meta-analysis by Chida (7). The authors found that
although various psychological interventions had a significant ameliorating
effect on itching intensity and scratching, further study is warranted to
strengthen the evidence. The psychological intervention to be investigated in
this study is Eye Movement desensitization and Reprocessing (EMDR) combined
with imaginary scratching. This combined intervention turned out to be
successful in a small number of individual treatments (5). However, this
intervention has not been subject of scientific research yet. Therefore, we
aim to investigate the effects of this intervention in a controlled study.
References:
1. Silverberg JI. Health Care Utilization, Patient Costs, and Access to Care in
US Adults With Eczema: A Population-Based Study. JAMA Dermatol.
2015;151(7):743-752.
2. Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The burden of
atopic dematitis: Summary of a Report for the National Eczema Association. J
Invest Dermatol. 2017;137(1): 26-30.
3. Simpson EL, Guttman-Yassky E, Margolis DJ, Feldman SR, Qureshi A, Hata T,
Mastey V, Wei W, Eckert L, Chao J, Arnold RJG, Yu T, Vekeman F, Suárez-Fariñas
M, Gadkari A. Association of inadequately controlled disease and disease
severity with patient *reported disease burden in adults with atopic
dermatitis. JAMA Dermatol. 2018; 154(8):903-912.
4.Misery L, Seneschal J, Reguiai Z, Merhand S, Héas S, Huet F, Taïeb C,
Ezzedine K. Patient Burden is Associated with Alterations in Quality of Life in
Adult Patients with Atopic Dermatitis: Results from the ECLA Study. Acta Derm
Venereol. 2018; 98(7): 713-714.
5. Doeksen D, ten Broeke E. Te mooi om waar te zijn? Behandeling van drie
patiënten met excessief krabben en tricotrillomanie. EMDR Magazine 19, 2009 ,
5-9.
6. Silverberg JI, Gelfand Jm, Margolis DJ,Boguniewicz M, Fonacier L, Grayson
MH, Simpson EL, Ong PY, Chiesa Fuxench ZC. Patient-burden and quality of life
in atopic dermatitis in US adults: A population-based cross-sectional study.
Ann Allergy Asthma Immunol. 2018;121(3): 340-347.
7. Chida Y, Steptoe A, Hirakawa N, Sudo N, Kubo C.The effects of psychological
intervention on atopic dermatitis. A systematic review and meta-analysis. Int
Arch Allergy Immunol. 2007;144(1):1-9.
Study objective
Primary Objective:
1.1 Does treatment according to the Dutch EMDR protocol for Urge reduce
scratching behavior in AD patients?
Hypothesis:
1.1 H1: Treatment according to the Dutch EMDR protocol for Body Focused
Repetitive Behavior , version scratching leads to a statistically significant
reduction of scratching behavior in AD patients.
Secondary Objective(s):
2.1 Does treatment according to the Dutch EMDR protocol for Urge improve
quality of life in AD patients?
2.2 Does treatment according to the Dutch EMDR protocol for Urge improve
perceived self-control in AD patients?
Hypotheses:
2.1 H1: Treatment according to the Dutch EMDR protocol for Urge leads to a
clinically relevant improvement in quality of life in AD patients.
2.2 H1: Treatment according to the Dutch EMDR protocol for Urge leads to a
clinically relevant improvement in perceived self-control in AD patients.
Study design
The current study applies a multiple baseline across subjects design, in which
participants will be randomly allocated to different baseline lengths. All
patients will start their daily registration at the same time, at day 1
(Monday) of week 1. After that, each participant, chosen randomly, will start
their treatments on a randomly chosen working day of one of the three following
weeks. The treatment phase is 10 days for all patients, and includes in total
two EMDR sessions that take place in the setting of the of the psychiatry
outpatient clinic of the Erasmus MC. The treatment phase is followed by a
follow-up phase. The total study duration, consisting of the baseline,
treatment and follow-up phase is 6 weeks and is equal for all participants.
*
Intervention
Eye Movement and Desensitization Reprocessing (EMDR) therapy an evidence-based
psychological treatment that is recommended by national guidelines for the
treatment of PTSD (8). Since then, it has been shown to be effective for a
variety of anxiety and somatic complaints (9-11). In the current study, The
Dutch EMDR protocol for Urge is tested. This protocol has recently been
developed and applied and clinical results so far have been positive. However,
scientific research on it*s effectivity so far is lacking. For this reason, we
aim to conduct the current study.
Working-memory theory offers an explanation for how EMDR might work (12, 13).
The theory states that the short-term or working memory can perform various
tasks at the same time. However, the working memory has a limited attention
capacity. As a result, by performing one task, performance on another task
comes under pressure. In EMDR for scratching behavior, the patient is asked to
focus on the distracting stimulus, but at the same time also to focus on the
urge to scratch his/her skin. So, the attention, which is focused on the urge
to scratch, is distracted by the eye movements. The hypothesis is that as a
result, 'decay' (desensitization) of the urge to scratch takes place and the
urge loses more and more of it*s urgency so to say.
In this study the EMDR intervention consists of two sessions of 90 minutes
divided over two weeks (so one session in week 1, and one in week 2). As the
after-effects of EMDR may last up to 3 days, this makes that the *treatment
phase* as described in the design (chapter 3) lasts 10 days in total (that is:
EMDR session 1 on day 1 of the treatment phase, EMDR session 2 on day 8 of the
treatment phase and day 8-10 as extra days to clear off the possible
after-effects of the last session). An important part of the Dutch EMDR
protocol for Urge consists of homework exercises. These homework exercises
comprise to practice/apply the intervention as learned during the sessions with
the therapist, in those situations wherein the urge to scratch their skin is
present. In the text below, we will explain in more detail what the treatment
protocol entails.
During the EMDR session with the therapist, the patient is asked to focus on
those spots on his/her skin where the urge to scratch is highest. The patients
is then asked to rate the level of urge on a 10-point scale and to imagine that
they scratch this sport as they would like. At the same time the distracting
stimulus is offered for 30 seconds. Then, the level or urge is rated again and
the procedure is repeated until the level of urge to scratch that particular
spot has become nihil. Then the patient is asked to imagine that this spot
has become *white*, that is calm and quite. Next, this procedure is repeated
for all skin parts where the patient may experience an urge to scratch, until
there are no skin parts left that the patients wished to scratch during the
session. As a homework assignment straight after the first session, the
patient is instructed and encouraged to practice the same intervention at home.
That is, each time that the patient experiences the urge to scratch his skin,
he should imagine that he/she is actually scratching in the way he/she would
like to do and at the same time focus on a distracting stimulus that taxes
working memory. This distracting stimulus is either the following of one*s own
finger moving from left to right, or by playing tetris on one*s mobile phone.
In case those distracting stimuli for whatever reason do not work for the
patient or in a particular situation, then the patient is asked to use
cognitive distraction, for instance by making calculations like distracting
from 200 with 7 per time. Experiences so far with these methods learns that
this is feasible for patients. Three working days after each of the
face-to-face sessions, the patient is called by the therapist to ask how the
practicing at home is going. In case the patient experiences difficulties in
practicing at home, these difficulties will be discussed and patient and
therapist together will aim to find a solution to enable practicing at home.
8. Balkom ALJM van, Vliet IM van, Emmelkamp PMG, Bockting CLH, Spijker J,
Hermens MLM, & JAC, M. (2013). MULTIDISCIPLINAIRE RICHTLIJN ANGSTSTOORNISSEN
Utrecht: Trimbos-instituut.
9. Logie RD, & de Jongh A. The Flashforward Procedure: Confronting the
Catastrophe. Journal of EMDR practice and research 2014; 8(1): 25-32.
10. Dautovic E, de Roos C, van Rood Y, Dommerholt A & Rodenburg R. Pediatric
seizure-related posttraumatic stress and anxiety symptoms treated with EMDR: a
case series. Eur J Psychotraumatol. 2016; 7: 10.3402/ejpt.v7.30123.
11. van Rood YR & de Roos C. EMDR in the treatment of medically unexplained
symptoms: a systematic review. Journal of EMDR practice and research 2009;
4(3): 248-263.
12. Engelhard IM, van den Hout MA, Dek EC, Giele CL, van der Wielen JW, Reijnen
MJ & van Roij B.Reducing vividness and emotional intensity of recurrent
"flashforwards" by taxing working memory: an analogue study. J Anxiety Disord.
2011; 25(4):599-603.
13. de Jongh A, Ernst R, Marques L, & Hornsveld H. The impact of eye movements
and tones on disturbing memories involving PTSD and other mental disorders. J
Behav Ther Exp Psychiatry 2013; 44(4): 477-483.
Study burden and risks
We expect that the intervention will reduce unwanted behavior, that is the
scratching worsening the skin condition in patients with AD. Apart from the
time investment (to attend two therapy sessions and to fill out the
questionnaires), no disadvantages are expected to participate in the study.
However, participants may be disappointment in case the experimental treatment
may not bring what the patients had hoped for. However, this is no other than
the risk any patient faces in undergoing experimental treatment.
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Age 18 >
- A confirmed diagnosis of AD
- Systemic treatment for AD with stable disease activity
- Suffering from persistent scratching behavior, no successful response to care
as usual
- Sufficiently motivated to take part in a new intervention aimed at behavior
change
Exclusion criteria
- Insufficient understanding of Dutch language
- Severe psychiatric disorders that require treatment first
- If medication is changed during the course of the study, the participant will
be considered a drop-out from the moment the medication has changed.
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 | NL72842.078.20 |