Primary Objective: 1.1 To assess the prevalence of fear of injections in patients with atopic dermatitis1.2 To assess the prevalence of fear of injections in the partners of patients with atopic dermatitis, as a proxy for the age-matched general…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the feasibility and acceptability of the EMDR-FF
treatment, measured four weeks after the check-up session. Feasibility will be
assessed by evaluating patient accessibility (evaluating any logistical or
practical barriers they encounter, such as travel, scheduling, or availability
of the treatment), time investment (both staff and patient), resource
allocation (EMDR kit), staff training, personnel capacity, and associated
costs. The treatment will be considered feasible if at least 80% of patients
can access the treatment without significant barriers, the required time and
resources are acceptable, and the personnel can be adequately trained within
the allocated timeframe. Percentages above 75% are often considered acceptable
[11].
Acceptability of the treatment will be determined through a comprehensive
analysis of individual structured interviews conducted four weeks
post-treatment. A topic list include a series of questions designed to gather
detailed feedback on various aspects of the patient's experience. To begin,
patients will be asked to describe their overall experience with the treatment,
providing an opportunity to express their general feelings and impressions.
They will then be encouraged to reflect on specific aspects of the treatment
they found positive, as well as any elements they found less pleasant.
The interviews will also explore practical aspects of the treatment by asking
patients whether they found it easy to follow and, if so, why. If they
experienced difficulties, they will be asked to elaborate on the challenges
they encountered, such as issues with scheduling sessions or following
instructions.
To assess the perceived effectiveness of the treatment, patients will be asked
if they believe it was successful in addressing their condition. Additionally,
the interview will address the topic of side effects by inquiring whether the
patient experienced any adverse effects during or after the treatment, and how
they managed these side effects.
Further, the interviews will identify any barriers or challenges the patients
faced while following the treatment. Finally, patients will be asked whether
they would recommend the treatment to others and why or why not, along with any
suggestions they may have for improving the treatment.
The treatment will be deemed acceptable if at least 75% of patients report a
positive experience or express satisfaction with the treatment during these
interviews [11].
11. Lambert, S.D., et al., A study protocol for a multicenter randomized
pilot trial of a dyadic, tailored, web-based, psychosocial, and physical
activity self-management program (TEMPO) for men with prostate cancer and their
caregivers. Pilot and Feasibility Studies, 2021. 7: p. 1-16.
Secondary outcome
Three secondary outcome measures are used:
- The Dutch translation of the Injection Phobia Scale - Anxiety (IPS-Anx) [12],
the Injectiefobie Schaal (IFS), The IFS is an 18-item self-report measure. For
the purpose of this study, two additional items are included, namely: *Having
an injection in your thigh* and *Having an injection in your belly*. Items are
scored on a 5-point Likert scale. It measures the anxiety level with different
injection and/or venepuncture procedures. Individuals rate their anxiety on a
scale ranging from 0 (No anxiety) to 4 (Maximum anxiety). The IFS is measured
at baseline (T0), post treatment 1 week after the check-up session (T1) and at
follow-up 4 weeks after the check-up session (T2).
- The SKINDEX-17, which is a dermatology-specific health-related quality of
life (HRQOL) instrument [13]. It consists of 17 items to be scored on a 5-point
Likert scale. The instrument has two subscales: psychosocial impact and impact
of symptoms. The SKINDEX-17 is measured at baseline (T0), post treatment 1 week
after the check-up session (T1) and at follow-up 4 weeks after the check-up
session (T2).
- The Generalised Anxiety Disorder - 7 (GAD-7) is a 7-item instrument which
assesses the severity of generalised anxiety disorder [14]. Patients are asked
to rate the severity of his or her symptoms over the past two weeks. Items are
scored on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day).
Other study parameters:
Patients are asked if they have experienced a traumatic event in the past that
may have caused the fear of injections at T0. Moreover, patients are asked at
T0 whether they have refused treatment in the past because of their fear of
injections. Further, the number of treatment sessions per patient (1-3) will be
registered.
12. Öst, L.-G., K. Hellström, and A. Kåver, One versus five sessions of
exposure in the treatment of injection phobia. Behavior therapy, 1992. 23(2):
p. 263-281.
13. Nijsten, T.E.C., et al., Testing and reducing skindex-29 using Rasch
analysis: Skindex-17. J Invest Dermatol, 2006. 126(6): p. 1244-1250.
14. Spitzer, R.L., et al., A brief measure for assessing generalized anxiety
disorder: the GAD-7. Archives of internal medicine, 2006. 166(10): p.
1092-1097.
Background summary
The prevalence of injection phobia in the adult population remains hard to
determine, but its consequences should not be underestimated. Prevalence rates
of fear of injections and needle phobia are estimated at 16.1% and 1.1%
respectively in the Netherlands [1]. The prevalence of needle fear varies
across different diseases, with rates ranging from 17-52% in cancer, 25-47% in
kidney failure, and 0.2-80% in diabetes patients [2]. However, the nature of
needle fear hampers incidence determination as those affected actively avoid
healthcare settings, potentially leading to an underestimation of the true
number [3].
Fear of injections can lead to intense anxiety and active avoidance. While
other specific phobias are generally not directly harmful and may have limited
impact on daily life, fear of injections can have serious implications for
therapy compliance and patient health. For example, during the COVID-19
pandemic, it was found that approximately 10% of vaccine hesitancy cases across
adults in the UK can be attributed to blood-injection-injury fears [4].
Chronically diseased patients may require injections as part of their
treatment. Avoiding these necessary injections due to fear of injections can
result in severe, even life-threatening, consequences. Ineffective treatment
outcomes can exacerbate health conditions, leading to increased healthcare
costs and a decline in patients' quality of life.
Standard psychological treatment for patients with specific phobias, including
needle fear, consists of cognitive behavior therapy, including exposure in vivo
and anxiety management techniques. Depending on the presence of a vasovagal
reaction, applied tension techniques are learned to prevent patients from
fainting [5, 6]. The goal of exposure therapy is to systematically expose
patients to their feared stimuli in a controlled environment until they reach a
point of realizing that the feared catastrophe does not occur.
Another treatment option is to utilize the 'flashforward procedure', an
application of EMDR therapy [7]. EMDR Flashforward (EMDR-FF) focuses on a
future fantasy image, typically involving a specific catastrophic outcome
resulting from a confrontation with the until then avoided object or situation.
The therapy aims to desensitize the image of the feared event in the future,
which gives the individual the chance to make a more realistic assessment of
the object or situation. For instance, in the case of fear of injections, a
patient may harbor a fearful imagination that the next injection will cause
unbearable pain. By utilizing EMDR-FF to desensitize this particular image, its
emotional intensity decreases, enabling the patient to undergo and persist with
the injection treatment more effectively.
Annually, in the Netherlands alone, around 2500 patients with atopic dermatitis
use biologicals, which are injected every two weeks. After a brief instruction
on how to inject, patients self-administer this injection at home. It is
expected that the incidence of fear of injections in this population is
underestimated, leading to insufficient attention being paid to treatment to
improve therapy adherence. The hypothesis is that one or more session(s) of
EMDR flashforward treatment can provide a solution in this regard.
1. Oosterink, F.M.D., A. De Jongh, and J. Hoogstraten, Prevalence of dental
fear and phobia relative to other fear and phobia subtypes. European journal of
oral sciences, 2009. 117(2): p. 135-143.
2. Duncanson, E., et al., The prevalence and evidence-based management of
needle fear in adults with chronic disease: A scoping review. Plos one, 2021.
16(6): p. e0253048.
3. Jenkins, K., II. Needle phobia: a psychological perspective. 2014, Oxford
University Press. p. 4-6.
4. Freeman, D., et al., Injection fears and COVID-19 vaccine hesitancy.
Psychological medicine, 2023. 53(4): p. 1185-1195.
5. Ayala, E.S., A.E. Meuret, and T. Ritz, Treatments for blood-injury-injection
phobia: a critical review of current evidence. Journal of psychiatric research,
2009. 43(15): p. 1235-1242.
6. Keijsers, G., et al., Protocollaire behandelingen voor volwassenen met
psychische klachten. 2017.
7. Logie, R. and A. De Jongh, The *Flashforward procedure*: Confronting the
catastrophe. Journal of EMDR Practice and Research, 2014. 8(1): p. 25-32.
Study objective
Primary Objective:
1.1 To assess the prevalence of fear of injections in patients with atopic
dermatitis
1.2 To assess the prevalence of fear of injections in the partners of patients
with atopic dermatitis, as a proxy for the age-matched general population
1.3 To assess the feasibility and acceptability of EMDR-FF in patients with
atopic dermatitis, who are eligible for biological treatment
Secondary Objective(s):
2.1 To investigate if EMDR-FF leads to reduction of fear of injections
2.2 To investigate if EMDR-FF leads to improvement of dermatology-specific
quality of life
2.3 To investigate if EMDR-FF leads to reduction of general anxiety
Study design
The current study applies a cross-sectional study to assess the prevalence of
fear of injections in patients with atopic dermatitis and their partners (if
applicable). Patients with clinically relevant levels of fear of injections
will receive one or more session(s) of EMDR-FF (for an explanation, see section
5.1), with a maximum of three sessions. Patients with atopic dermatitis from
the dermatology outpatient clinic of the Erasmus University Medical Center are
asked to complete a questionnaire about fear of injections. Patients who report
clinically relevant levels of fear of injections, and who are eligible for
biological treatment, are offered EMDR-FF following a case series design.
Feasibility and acceptability through individual structured interviews are
determined 4 weeks after the check-up session. The therapy sessions take place
in the setting of the dermatology outpatient clinic of the Erasmus University
Medical Center. Secondary measurements at baseline (T0), post treatment 1 week
after the check-up session (T1) and at follow-up 4 weeks after the check-up
session (T2) are administered online. Castor EDC will be used to collect the
data.
Intervention
EMDR Flashforward (EMDR-FF) focuses on the adverse image of an imagined future
event, typically involving a specific catastrophic outcome resulting from a
confrontation with an object or situation that elicits irrational fear [7]. The
therapy aims to desensitize the image of the feared event in the future, which
gives the individual the chance to make a more realistic assessment of the
object or situation that is avoided until then. For instance, in the case of
fear of injections, a patient may harbour a fearful imagination that the next
injection will cause unbearable pain. By utilizing EMDR-FF to desensitize this
image, the emotional intensity decreases, enabling the patient to make a more
realistic assessment of the future situation (in this case, the injection
treatment).
Working-memory theory offers an explanation for how EMDR(-FF) might work [9,
10]. The theory states that the working memory has a limited attention
capacity. As a result, by performing one task, performance on another task
comes under pressure. In EMDR-FF, the patient is asked to focus on a
distracting stimulus, but at the same time also to focus on the image of the
imagined future catastrophe. The hypothesis is that as a result, 'decay'
(desensitization) of the fear evoked by the *catastophy image* takes place.
The therapy consists of one to three session(s) of approximately 60 to 90
minutes. EMDR-FF will be applied according to the Dutch version of the standard
EMDR Flashforward protocol (version 2023). First the goal of the intervention
is explained. Next, the flashforward target image (i.e. an image of the
ultimate doomsday scenario) is identified. This flashforward is desensitised
using the standard EMDR protocol, followed by the mental video check and future
template procedures, to test the extent into which patients perceive themselves
as (now) able to face the until then feared situation in real life.
7. Logie, R. and A. De Jongh, The *Flashforward procedure*: Confronting the
catastrophe. Journal of EMDR Practice and Research, 2014. 8(1): p. 25-32.
9. 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.
10. 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 reduce fear of injections in patients with
chronic skin diseases. Apart from the time investment (to fill out the
measurement and to attend the therapy session(s)), no disadvantages are
expected to participate in the study.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Cross-sectional study:
- Age 18 >=
- Moderate to severe atopic dermatitis, or:
- Partner of a patient with atopic dermatitis
Case series study:
- IFS score > 25
- Patients who receive injections (biologicals) as treatment for atopic
dermatitis; or
patients who are eligible for biological treatment.
Exclusion criteria
- Insufficient understanding of Dutch language.
- Severe psychiatric disorders that require treatment first, such as delusional
disorder or major depression.
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 | NL86920.078.24 |