Primary Objective: To assess the add-on effect of the EMD-U treatment compared to CAU, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour. Hypothesis…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the dermatology-specific health-related quality of
life (HRQOL), measured at the start of the study (T0), in week 4 (T1), in week
8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). The
SKINDEX-29 is used to measure this outcome. It consists of 30 items to be
scored on a 5-point response scale. The instrument has three subscales:
symptoms, emotions, and functioning [17].
17. Chren, M.-M., et al., Improved discriminative and evaluative capability of
a refined version of Skindex, a quality-of-life instrument for patients with
skin diseases. Archives of dermatology, 1997. 133(11): p. 1433-1440.
Secondary outcome
Secondary outcomes are several commonly used measures for disease activity,
health-related quality of life, self-control, depression and anxiety, and skin
picking. All standardized measures are administered at four time points: at the
start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up,
in week 12 (T3) and six months after T0 (T4). The standardized measures used
are:
Disease activity, measures to be filled out by dermatologist or dermatology
resident:
The disease activity of patients with atopic dermatitis is scored using the
Eczema Area and Severity Index (EASI) [18]. This is a validated scoring system
that grades the physical signs of atopic dermatitis/eczema.
For patients with prurigo nodularis and excoriation disorder, the Investigator
Global Assessment (IGA) is used. The IGA is a 5-point tool for the objective
assessment of chronic prurigo. The IGA for stage of chronic nodular prurigo
(CNPG) and signs of activity in chronic prurigo are used [19].
Health-related Quality of Life measure, to be filled out by the patient: The
EQ-5D-5L 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 [20].
Self-Control, measures to be filled out by the patient: The Self-Control
Cognition Questionnaire, Dutch: Zelfcontrole Cognitie Vragenlijst (ZCCL). The
ZCCL is an 11-item self-report questionnaire measuring perceived self-control.
There are two subscales: *positive reward* (of the unwanted behaviour) and
*difficulty resisting*. Each item is scored on a 5-point Likert scale [21].
Depression and anxiety, measures to be filled out by the patient: The four item
Patient Health Questionnaire for anxiety and depression (PHQ-4). The PHQ-4 is a
brief self-report screening tool for depression and anxiety, consisting of four
items. Two items on depression, and two items on anxiety are scored with a
4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day) [22].
Skin picking, measures to be filled out by the patient: The Skin Picking Scale
(SPS) is a six-item self-report measure for the assessment of skin picking
behaviour. The scale has a total score range of 0-24 [23].
18. Chopra, R., et al., Severity strata for Eczema Area and Severity Index
(EASI), modified EASI, Scoring Atopic Dermatitis (SCORAD), objective SCORAD,
Atopic Dermatitis Severity Index and body surface area in adolescents and
adults with atopic dermatitis. Br J Dermatol, 2017. 177(5): p. 1316-1321.
19. Zeidler, C., et al., Investigator*s Global Assessment of chronic prurigo: a
new instrument for use in clinical trials. Acta Derm Venereol, 2021. 101(2): p.
adv00401-adv00401.
20. Janssen, M.F., et al., Measurement properties of the EQ-5D-5L compared to
the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res,
2013. 22(7): p. 1717-1727.
21. Maas, J., et al., The Self-Control Cognition Questionnaire. Eur J Psychol
Assess, 2015.
22. Kroenke, K., et al., An ultra-brief screening scale for anxiety and
depression: the PHQ-4. Psychosomatics, 2009. 50(6): p. 613-621.
23. Keuthen, N.J., et al., The Skin Picking Scale: scale construction and
psychometric analyses. Journal of psychosomatic research, 2001. 50(6): p.
337-341.
Background summary
Scratching is a common behaviour in people with dermatological conditions such
as eczema, prurigo nodularis, and other itchy skin conditions. While scratching
can provide temporary relief from itching, it can also lead to further damage
to the skin. As a result, reducing scratching behaviour may have an impact on
dermatology-specific quality of life in multiple ways. First, reducing
scratching can help to reduce the severity and frequency of symptoms associated
with dermatological conditions. This may lead to an improvement of the skin
condition, which can improve a person's overall physical health and well-being.
Moreover, the impaired skin resulting from scratching, can be a significant
source of emotional distress for individuals with dermatological conditions,
leading to feelings of embarrassment and shame, and diminished social
interactions, as individuals may avoid certain activities or situations due to
concerns about their appearance. By reducing scratching behaviour and improving
skin health, individuals may feel more confident and comfortable in their own
skin, leading to improved emotional well-being and a better quality of life.
An evidence-based psychological treatment to reduce scratching behaviour is
cognitive behavioural therapy, based on *self-control procedures* and *habit
reversal*. Habit reversal has been shown to be effective in treating unwanted
habits, such as thumb-sucking, eyelash-picking, and scratching [1-4]. Habit
reversal applies an 'incompatible response': an activity that is incompatible
with performing the unwanted habit (i.e., wearing cotton gloves that make
scratching impossible). Beside self-control procedures and habit reversal,
self-monitoring or registration of habitual behaviour is a common component of
effective cognitive-behavioural treatments, which often leads to a decrease in
the frequency of this behaviour [5, 6]. More recent, novel types of treatment
to reduce scratching behaviour in AD patients appear to be effective, such as
internet-delivered and exposure-based cognitive behavioural therapy [7, 8].
The EMD protocol for urge (EMD-U) is a recently developed treatment which draws
on elements of Eye Movement Desensitization and Reprocessing (EMDR) therapy,
cognitive behavioural therapy, and hypnotherapy. In the current treatment, not
the full EMDR procedure is applied, but only the EMD-part - that is the
desensitization part. Desensitization aims at reducing the urge to perform
certain behaviour, in this case the scratching [9]. Patients are allowed to
perform the scratching in imagination, which shows similarities with the
EMDR-technique of *cognitive interweaves*. Furthermore, the treatment protocol
draws on elements of cognitive behaviour therapy, as self-registration of
behaviour and homework assignments are core elements of treatment. Finally,
elements of hypnotherapy are incorporated in this treatment, with respect to
the interpretation to perceive the treated skin spots - that does (no longer)
evokes the urge to scratch - as *calm and white*. This protocol turned out to
be successful in a number of individual treatments [10]. The results of the
first study to scientifically investigated this intervention in patients with
atopic dermatitis seem promising in that they show a decrease in scratching
behaviour [11]. In addition, this intervention is currently being investigated
in patients with prurigo nodularis.
1. Azrin, N.H. and R.G. Nunn, Habit-reversal: a method of eliminating nervous
habits and tics. Behaviour research and therapy, 1973. 11(4): p. 619-628.
2. Daunton, A., C. Bridgett, and J.M.R. Goulding, Habit reversal for refractory
atopic dermatitis: a review. The British journal of dermatology, 2016. 174(3):
p. 657-9.
3. Tsakok, T., et al., The effectiveness of habit reversal on treatment outcome
and quality of life in patients with chronic eczema: a prospective
observational study in the UK. Br J Dermatol, 2017. 177(2): p. 554-556.
4. Teng, E.J., D.W. Woods, and M.P. Twohig, Habit reversal as a treatment for
chronic skin picking: a pilot investigation. Behavior modification, 2006.
30(4): p. 411-422.
5. Korotitsch, W.J. and R.O. Nelson-Gray, An overview of self-monitoring
research in assessment and treatment. Psychol Assess, 1999. 11(4): p. 415.
6. Maas, J., et al., Changing automatic behavior through self-monitoring: does
overt change also imply implicit change? J BEHAV THER EXP PSYCHIATRY, 2013.
44(3): p. 279-284.
7. Hedman-Lagerlöf, E., et al., Internet-Delivered Cognitive Behavior Therapy
for Atopic Dermatitis: A Randomized Clinical Trial. JAMA dermatology, 2021.
157(7): p. 796-804.
8. Hedman-Lagerlöf, E., et al., Exposure-based cognitive behavior therapy for
atopic dermatitis: an open trial. Cognitive behaviour therapy, 2019. 48(4): p.
300-310.
9. Markus, W., et al., Addiction*focused Eye Movement Desensitization and
Reprocessing Therapy as an Adjunct to Regular Outpatient Treatment for Alcohol
Use Disorder: Results from a Randomized Clinical Trial. Alcohol Clin Exp Res,
2020. 44(1): p. 272-283.
10. Doeksen, D. and E. ten Broeke, Te mooi om waar te zijn? Behandeling van
drie patiënten met excessief krabben en tricotrillomanie, in EMDR Magazine.
2009. p. 5-9.
11. de Veer, M.R., et al., Reducing scratching behavior in atopic dermatitis
patients using the EMDR treatment protocol for urge: a pilot study. Frontiers
in Medicine, 2023. 10: p. 660.
Study objective
Primary Objective:
To assess the add-on effect of the EMD-U treatment compared to CAU, in
improving dermatology-specific quality of life in patients with atopic
dermatitis or prurigo nodularis who suffer from severe scratching behaviour.
Hypothesis: EMD-U treatment leads to significant improvement of
dermatology-specific quality of life, compared to CAU.
Secondary Objective(s):
2.1 To investigate if EMD-U treatment leads to significant improvement of the
skin condition, compared to CAU.
2.2 To investigate if EMD-U treatment leads to significant improvement of
health-related quality of life, compared to CAU.
2.3 To investigate if EMD-U treatment leads to significant improvement of
perceived self-control, compared to CAU.
2.4 To investigate if EMD-U treatment leads to significant improvement of
perceived severity of depression and anxiety, compared to CAU.
2.5 To investigate if EMD-U treatment leads to significant improvement of
perceived severity of skin picking, compared to CAU.
Hypotheses:
2.1 H1: EMD-U treatment leads to a clinically relevant improvement in skin
condition, compared to CAU.
2.2 H1: EMD-U treatment leads to a clinically relevant improvement in
health-related quality of life, compared to CAU.
2.3 H1: EMD-U treatment leads to a clinically relevant improvement in perceived
self-control, compared to CAU.
2.4 H1: EMD-U treatment leads to a clinically relevant improvement in perceived
severity of depression and anxiety, compared to CAU.
2.5 H1: EMD-U treatment leads to a clinically relevant improvement in perceived
severity of skin picking, compared to CAU.
Study design
The current study applies open randomized controlled trial, in which
participants will be randomly allocated to one of two treatment conditions:
EMD-U or CAU. After a patient is found eligible to participate in this study,
the patient is randomly assigned to one of the conditions. Prior to the start
of the intervention, patients should have a stable treatment course for 2
weeks. Patients in the EMD-U condition receive the EMD-U treatment in addition
to the care as usual. The EMD-U treatment lasts eight weeks, in which two EMD-U
sessions take place and patients are called twice in the first three weeks.
After the first EMD-U session, the patients apply the learned technique at home
until the end of the study. During the following five weeks, patients are
called twice to ask for their experiences with the practicing at home. A
follow-up meeting takes place twelve weeks and 6 months after the start of the
study. Physical appointments for the EMD-U treatments take place in the setting
of the dermatology outpatient clinic of the Erasmus MC. Patients in the CAU
condition receive only care as usual during the study period.
Intervention
EMD-U:
The EMD protocol for urge has recently been developed and applied and clinical
results so far have been positive [11, 14]. Working-memory theory offers an
explanation for how EMDR might work [15, 16]. 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
EMD-U, 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 its urgency.
EMD-U consists of two sessions of 60 minutes in the first three weeks. An
important part of EMD-U 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. Patients in this condition receive the EMD-U
treatment in addition to the care as usual.
In the EMD-U sessions, the patient is asked to focus on the spot on his/her
skin where the urge to scratch is highest. The patient then is asked to rate
the level of urge to scratch this spot on a 10-point scale and to imagine that
they scratch this spot as they would like. At the same time eye movements are
offered for 30 seconds. Then, the level of urge is rated again, and the
procedure is repeated until the level of urge to scratch that particular spot
has become nihil. After that the patient is asked to imagine that this spot had
become *white*, that is calm and quiet. Next, this procedure is repeated for
all other skin parts where the patient experiences an urge to scratch, until
there are no skin parts left that the patient wishes 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 has
to imagine that he is actually scratching in the way he 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 playing Tetris on one*s mobile phone. Within three days after
both face-to-face sessions, the patient is called by the therapist to ask for
their experiences with the practicing at home. In case the patient experiences
difficulties in practicing at home, these difficulties are discussed, and
patient and therapist together try to find a solution to enable practicing at
home. The two EMD-U sessions and two phone calls, take place in the first three
weeks of the study. After the first EMD-U session, the patients apply the
learned technique at home until the end of the study. During the following five
weeks, patients are called twice to ask for their experiences with the
practicing at home.
CAU:
Patients in the control group receive care as usual (CAU), which is the
standard care of the dermatologist. In addition to completing the
questionnaires at T0, 1, 2, 3, and 4 these patients are not offered any
additional treatment or support aimed at their scratching behaviour.
11. de Veer, M.R., et al., Reducing scratching behavior in atopic dermatitis
patients using the EMDR treatment protocol for urge: a pilot study. Frontiers
in Medicine, 2023. 10: p. 660.
14. Doeksen, D. and E. ten Broeke, Te mooi om waar te zijn? Behandeling van
drie patiënten met excessief krabben en tricotrillomanie, in EMDR Magazine.
2009. p. 5-9.
5. Engelhard, I.M., et al., Reducing vividness and emotional intensity of
recurrent *flashforwards* by taxing working memory: An analogue study. Journal
of anxiety disorders, 2011. 25(4): p. 599-603.
16. de Jongh, A., et al., The impact of eye movements and tones on disturbing
memories involving PTSD and other mental disorders. Journal of behavior therapy
and experimental psychiatry, 2013. 44(4): p. 477-483.
Study burden and risks
We expect that the intervention will improve dermatology-specific quality of
life and reduce unwanted behaviour, that is the scratching worsening the skin
condition of the patients. Apart from the time investment (to attend two
therapy sessions and to fill out the questionnaires), no disadvantages are
expected toparticipate 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 atopic dermatitis or prurigo nodularis
- Suffering from persistent and frequent scratching behaviour
- IGA-CPG activity score >= 3 OR Skindex-29 symptoms subscale score >= 42
- Stable course of treatment in the two weeks prior to the study (no medication
change, etc.)
- Sufficiently motivated to take part in a new intervention aimed at behaviour
change
Exclusion criteria
- Insufficient understanding of Dutch language
- Severe psychiatric disorders that require treatment first, such as delusional
disorder or major depression
- 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 | NL84417.078.23 |