The primary objective is to assess the effectiveness of a brief (two half-day) in person (EMDRip) and remote (EMDRr) EMDR therapy in reducing posttraumatic stress symptoms in parents of children with a chronic or acute medical condition. The…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Posttraumatische stress en psychologische comorbiditeit ten gevolge van het zorgen voor een kind met een medische aandoening.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the effectiveness (decrease in posttraumatic stress symptoms on the
PCL-5) of brief EMDRip and EMDRr for parents of children with a severe chronic
or acute medical condition, an intention-to-treat analysis will be performed
including all participants originally enrolled in the study, the data will be
assessed using linear mixed model analysis (LMM). The long-term treatment
effect will be investigated using the Mixed Model Repeated Measures (MMRM)
variant of Linear Mixed Model analysis.
The PCL-5 is one of the most widely used self-report measures of post-traumatic
stress disorder (PTSD) in research and clinical contexts across various trauma
types and populations (Bovin et al., 2016, Blevins et al., 2015). The 20-item
PCL-5 measures PTSD symptoms of the DSM-5 on a five-point Likert scale, ranging
from 0 *not at all* to 4 *extremely*.
The 20-items are divided across the DSM-5 clusters intrusions (B), avoidance
(C), alterations in arousal and reactivity (D), and negative alterations in
cognitions and mood (E) (American Psychiatric Association, 2013). To calculate
the score on the PCL-5 each item rated 2 (moderately) or higher is selected, on
these items the DSM-5 rule is applied (one B symptom, one C symptom, two D
symptoms, and two E symptoms).
Parents will be included in this study if they meet one of the three conditions
below on the PCL-5: 1) a 'moderate or higher' (2-4) score for at least one
symptom in each cluster (B, C, D or E); or 2) three of the four PTSD criteria
(one B-symptom, one C-symptom, two D-symptoms and two E-symptoms), or 3)
(sub)clinical total score (>24).
The PCL-5 has been thoroughly researched and shows excellent psychometric
properties in numerous studies (Van Praag et al., 2020, Bovin et al., 2016,
Blevins et al., 2015). Blevins et al. (2015) found strong internal consistency
(α = .94), test-retest reliability (r = .82), and convergent (rs = .74 to .85)
and discriminant (rs = .31 to .60) validity. Van Praag et al. (2020) found
excellent internal consistency (α = .93) and a high reliability (r = .96) for
the Dutch-translation of the PCL-5.
Secondary outcome
To assess the effectiveness of (1) decrease in psychopathology on the BSI
Somatization/Promis Anxiety/Promis Depression, 2) decrease in parental stress
on the DT-P, 3) decrease in everyday parenting problems on the OBVL, 4)
increase in partner relationship quality on GVL subscale Partner Relationship,
5) increase in relationship quality with chronically ill child on OBVL subscale
Parent-child relationship problems, 6) decrease in posttraumatic stress
symptoms child on CATS) of the brief EMDRip and EMDRr for parents of children
with a severe chronic or acute medical condition, an intention-to-treat
analysis will be performed including all participants originally enrolled in
the study. The long-term treatment effect will be investigated using the Mixed
Model Repeated Measures (MMRM) variant of Linear Mixed Model analysis.
To exploratory assess the moderating effect of social support and relationship
quality on the effectiveness of EMDRip and EMDRr (on the PCL-5) an
intention-to-treat analysis will be performed including all participants
originally enrolled in the study and the data will be assessed using linear
mixed model analysis (LMM) including social support and relationship quality
(GVL subscale Social Support, GVL subscale Partner Relationship) as moderators
among potential other variables.
Measurement instruments used:
Psychopathology:
Brief Symptom Inventory-18 subscale Somatic Symptoms (SOM, BSI-18) (de Beurs,
2011): Providing insight into the extent to which the respondent has
experienced physical symptoms during the past week. The score on the subscale
can be calculated with a maximum score of 24. A higher score represents more
physical complaints. The Somatic symptoms subscale has proven to be reliable, α
= .74[42].
PROMIS item banks: The PROMIS questionnaires are administered via Computer
Adaptive Tesst (CAT) in which a follow-up question is selected based on
previously given answers, this way a reliable outcome can be obtained with
fewer questions (Cella et al., 2007).
- PROMIS Anxiety Dutch item bank: measures anxiety focusing on hyperarousal,
fear, stress, and related somatic symptoms (Pilkonis et al., 2011). The PROMIS
Anxiety bank comprises 29 items that are focused on a 7-day time frame and a
5-point rating scale varying from 1 (Never) to 5 (Always). A sample question
from the Anxiety subscale: "I felt nervous". A higher score means more presence
of the measured construct.
- PROMIS Depression: measures negative mood, self-image, affect, and social
interaction (Pilkonis et al., 2011). The PROMIS Depression bank comprises 28
items that are focused on a 7-day time frame and a 5-point rating scale varying
from 1 (Never) to 5 (Always). A sample question from the Depression subscale:
"I felt unhappy". A higher score means more presence of the measured construct.
Parental stress:
Opvoedingsbelasting Vragenlijst (OBVL) (Veerman et al., 2014): The OBVL is a
Dutch self-report questionnaire that assesses experienced parenting stress. The
questionnaire consists of 34 items divided into five sections: 1) Parent-child
relationship problems, 2) Parental incompetence, 3) Depressed mood, 4) Role
restriction, and 5) Health complaints, measured on a four-point Likert scale
(1= does not apply to 4= applies completely). When answering the questions, the
parent should keep one particular child aged zero to eighteen in mind. An
example question of the section Role restriction is: "I would like to visit
friends and acquaintances more often, but it's not possible because of my
child." The reliability (α = .90) and construct validity of the OBVL were found
to be good in a study among Dutch parents (Veerman et al., 2014).
Distress Thermometer for Parents (DT-P) (Haverman et al., 2013): The DT-P
measures the degree of parental distress experienced by parents of a
chronically ill child in the past week via a self-report questionnaire. The
DT-P consists of three parts: a) a distress thermometer on which the degree of
distress is indicated on a 10-point scale (0= no distress to 10= extreme
distress), b) the 29-item dichotomous problem list, c) a questionnaire section
focused on the care of the sick child An example question from the care section
is: "How is the interaction with medical personnel?". The DT-P has proven to be
a reliable (internal consistency α >= .90) and valid instrument for measuring
levels of distress in parents with a chronically ill child (Haverman et al.,
2013).
Partnerrelationship and family social network:
Gezinsvragenlijst (translation: Family Questionnaire) subscales Partner
Relationship and Social Network (Van der Ploeg & Scholte, 2008): The GVL
assesses relationship quality and parental support of children in the age of 4
to 18 using five subscales. In this study we only include the subscales of the
GVL that are relevant to our research questions and unique to the GVL, namely
Partner Relationship and Social Network. The subscales of the GVL are completed
by the parent or caregiver, each subscale consists of 9 items with a 5-point
Likert scale (0= strongly disagree, 5= strongly agree). Sum scores will be
calculated for each subscale after recoding the contraindicated items, with
higher scores representing lower functioning. The Partner Relationship and
Social Network have proven to be reliable subscales, α = .91 (Van der Ploeg &
Scholte, 2008).
Traumasymptoms child:
Child and Adolescent Trauma Screen (CATS) 3-6 and 7-17 parent version (Kooij &
Lindauer, 2019): The CATS questionnaire is based on the DSM-5 criteria for
post-traumatic stress disorder (PTSD). The questionnaire identifies possible
trauma and trauma-related problems in children and adolescents. The CATS 3-6
questionnaire version consists of 37 items divided into three sections: 1)
Traumatic Events (16 items), 2) DSM-5 criteria for PTSD (16 items), and 3)
Child Psychosocial Functioning (5 items). The CATS has been validated in
Germany, Norway and the United States (Sascher et al., 2022). Research on the
psychometric proportions of the Dutch version is in its final stages. Initial
results for the psychometric research of the CATS 7-17 Dutch parent version
show excellent internal consistency (α = .91).
Background summary
Living with a severe chronic or acute medical condition has a great impact on
the life of the child and the family members. Parents of children with a severe
chronic or acute illness often face potential traumatic events e.g.,
illness-related life threat, painful procedures for the child, procedures with
negative side effects, or dangerous treatment complications. The accumulation
of exposure to traumatic events can lead to symptoms of post-traumatic stress
disorder (PTSD) for parents as well for the ill child. The first choice
evidence based treatment for PTSD is Eye Movement Desensitization and
Reprocessing (EMDR) usually offered in multiple sessions spread over weeks or
months (de Jongh et al., 2024; de Jongh et al., 2020). Parents of children with
a with a severe chronic or acute illness often do not receive this treatment
due to a variety of reasons: 1) parents are more focused on the well-being of
the child and do not report their own psychosocial problems, 2) within a
children*s hospital parents have no entitlement to reimbursed care, 3) parents
often live at considerable distance from Emma Children's Hospital, Amsterdam
UMC as the hospital provides tertiary care, 4) parents are overburdened so
long-term trauma therapy is not feasible. Therefore, a more brief EMDR
treatment might be beneficial. In a previous pilot RCT-study we found positive
effects of EMDR-therapy for parents of mucopolysaccharidosis III (MPS III)
patients (Conijn et al., 2022). We will now study the effect of two modalities
of brief EMDR treatment in reducing PTSD symptoms and comorbid symptoms for
parents of children with diverse severe medical conditions.
Study objective
The primary objective is to assess the effectiveness of a brief (two half-day)
in person (EMDRip) and remote (EMDRr) EMDR therapy in reducing posttraumatic
stress symptoms in parents of children with a chronic or acute medical
condition.
The secondary objectives are to assess:
1) the effectiveness of brief EMDRip and EMDRr therapy in reducing
psychological comorbidity (psychopathology in general: Depression, Anxiety and
Somatization), and parenting stress,
2) the effectiveness of brief EMDRip and EMDRr therapy on the posttraumatic
stress symptoms of the child with a chronic or acute medical condition,
3) the effectiveness of brief EMDRip and EMDRr therapy in improving
relationship quality between the parent and spouse and between the parent and
the child with the severe chronic or acute medical condition,
Furthermore, we investigate:
4) the feasibility of EMDRip vs. EMDRr,
5) the traumatic experiences and future worries the parents of children with a
severe chronic or acute illness struggle with (intake data).
Study design
This study will be a randomized controlled trial with three study arms: in
person EMDR (EMDRip), remote EMDR (EMDRr), wait list (Control).
Parents whose child is under care at the Emma Children*s Hospital will be
notified about the study in various ways. If parents are willing to participate
in the study, they can email or call the researcher for additional information.
During this point of contact (telephone or email) parents can ask questions
about participation in the study.
After this first point of contact a reflection period of one week will start,
if parents wish to participate in the study after the reflection period, the
researcher will ensure that Tscreen is ready in the KLIK portal, the
questionnaire software that will be used for this study. Before answering
Tscreen all parents have to confirm actively that they are aware how their
privacy and data will be managed, and that their answers on the questionnaires
will be used for the current study (Tscreen Informed Consent). This informed
consent form also includes a digital link to the information letter, for
parents to read the information again if desired. In addition, parents have the
possibility to ask questions to the researcher by e-mail or phone.
Parents meeting the inclusion criteria at Tscreen are contacted by the
researcher (via email or telephone) to inform them that they are eligible to
participate. During this contact moment parents can ask questions and can
indicate whether they want to participate in the research project. If they
decide to participate, they will fill-out T0, for which informed consent for
the complete study is obtained electronically via the KLIK portal. The
electronic informed consent form includes a digital link to the information
letter so that parents can read all the information again prior to signing.
During the T0 informed consent procedure, informed consent is signed by the
parent and by the researcher in separate forms. We organize the informed
consent procedure online so that it proceeds the same for all parents
participating in this study.
After answering the T0 questions parents will be randomized across the three
study conditions: EMDRip (N=20), EMDRr (N=20), and Control (N=20).
Parents in EMDRip and EMDRr will be contacted to schedule a semi-structured
intake interview. One week after the semi-structured intake interview, the
short EMDR treatment programme starts, the total duration is 6 hours (4 x
1.5-hour EMDR session, 2 days).
The EMDR-treatment is focused on traumatic experiences related to the child*s
medical condition. The first and second treatment day will be scheduled a week
apart (with a maximum of two weeks if one week is not realisable for the
parent). Two weeks (T1ip, T1r, T1c) and three months (T2ip, T2r, T2c) post
treatment parents in all three arms will receive a link to fill out the
selected online questionnaires. Parents in EMDRip and EMDRr will receive the
same questionnaires 6 months (T3ip, T3r) post treatment. Parents in the
waitlist arm can start with the EMDR-treatment programme after the T2c
measurement, they will be randomized into EMDRip or EMDRr. EMDRip will be
carried out at Amsterdam UMC. For EMDRr both the intake session and
EMDR-treatment programme will be carried out online.
Intervention
The intervention that will be used in this Randomized Controlled Trial is EMDR
therapy. The EMDR therapy will be provided by licensed master*s degree
(clinical) psychologists and advanced EMDR practitioners, working at Emma
Children*s Hospital/Amsterdam UMC or LEVVEL/Amsterdam UMC.
Intake session
The therapist and parent will develop a standardized case conceptualization
consisting of a hierarchy of disturbing and stressful memories of traumatic
experiences or flash forwards (anticipation fear of the future) regarding the
disease of their child. If an acute medical or psychiatric condition appears to
be present (such as psychosis, substance dependence or high risk for suicide),
brief EMDR is not indicated and the therapist will refer the parent to more
appropriate psychosocial/psychiatric support. Besides the EMDR therapist, a
researcher (that is also a psychologist) or psychological intern will be
present to take notes.
EMDR treatment
EMDR treatment (4 x 1.5 hour divided over 2 days) will be offered by following
the standard eight-phase protocol presented by De Jongh and Ten Broeke (2003).
There will be one week between the first and second treatment day (a maximum of
two weeks if one week is not realisable for parents). During an EMDR session,
the parent focuses on emotionally disturbing memories (image, thoughts,
emotions and sensations) in brief sequential doses while simultaneously
focusing on an external distracting stimulus (e.g., lateral eye movements). The
treatment is focused on past, present and future aspects of the emotionally
disturbing memories and flash forwards (Shapiro, 2001). This process
facilitates accessing the traumatic memory network so information processing is
enhanced and new associations can be made between the traumatic memory and more
adaptive memories and information (Shapiro, 2001). As a result, the traumatic
memory representation will be less intense and emotionally disturbing. Besides
the EMDR therapist, a researcher (that is also a psychologist) or psychological
intern will be present to take notes. After the last day of treatment, parents
are informed that they can contact the researchteam at any time if they need
(psychological) support before the end of the study.
Study burden and risks
Parents will spend about 7.5 hours participating in the therapy, one 1.5 hour
intake session and four 1.5-hour treatment sessions. In addition, parents will
be asked to fill out online questionnaires (www.hetklikt.nu). The research
starts with a 10-minute Tscreen questionnaire for all parents. Following, a
questionnaire lasting about 45 minutes at four time points (T0ip/T0r, T1ip/T1r,
T2ip/T2r, T3ip/T3r) for EMDRip and EMDRr, where parents in Control do so during
five measurement moments (T0c, T1c, T2c, T1.1c, T2.1c). Participation in the
study entails negligible risks for the parents participating. Eye Movement
Desensitization and Reprocessing (EMDR) is a safe method for treating
post-traumatic stress symptoms without side effects when applied by a qualified
therapist. Our previous pilot study has shown that short-term treatment of two
half-days is effective, safe, feasible and acceptable for patients (Conijn et
al., 2022). In addition, EMDR has been successfully offered remote in recent
years (Fisher, 2021). Stress symptoms experienced by the parent have a
significant impact on the child. Therefore, treatment may be not only
beneficial for the psychosocial wellbeing of the parent but also for the severe
chronic or acute ill child.
If the research results show that EMDR treatment is effective for parents of
children with a severe chronic or acute medical condition with (subclinical)
PTSD, screening and treatment of parents should be implemented in clinical
practice with EMDR treatment becoming one of the standard reimbursed forms of
treatment so that family-centered care at the Emma Children's Hospital could be
permanently improved.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria (protocol 4.2 Inclusion criteria):
- One of the three conditions on the PTSD Check List for DSM-5 (PCL-5): 1) A
score of 2-4 (moderate or higher) on one symptom in each cluster (B, C, D or
E); 2) Three of the four PTSD criteria (one B symptom, one C symptom, two D
symptoms and two E symptoms); 3) A (sub) clinical total score (>24). .
- Being motivated for brief EMDR treatment.
- Parenting a child under treatment of a healthcare provider at the Emma
Children*s Hospital, Amsterdam UMC.
- Having sufficient knowledge of the Dutch language to complete the
assessments.
Exclusion criteria
Exclusion criteria (protocol 4.3 Exclusion criteria):
- Major interfering acute medical or psychiatric condition, such as psychosis,
substance dependence or high risk for suicide.
- Insufficient fluency of the Dutch language.
- Receiving psychological (trauma) treatment by another therapist at the same
time.
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 | NL85854.018.24 |