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Trial Title:
Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients
NCT ID:
NCT06339814
Condition:
Caregiver Burden
Conditions: Official terms:
Caregiver Burden
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study will be with two parallel branches, thus conforming to a Randomized Group
Treatment Trial: Eye Movement Desensitization and Reprocessing Integrative Group
Treatment Protocol (those who will receive Eye Movement Desensitization and Reprocessing
treatment plus the standard support) versus Treatment As Usual condition (those who will
receive only standard support). The assessment will be performed at the moment of
recruitment (T0), after the intervention for the Eye Movement Desensitization and
Reprocessing Integrative Group Treatment Protocol group and after 1 month for the
Treatment As Usual condition (T1), and for both 2 months after T1 (T2).
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol
Description:
An Eye Movement Desensitization and Reprocessing psychotherapist will hold the Eye
Movement Desensitization and Reprocessing Integrative Group Treatment Protocol sessions,
dedicated to psychoeducation, imagery exercises, stabilization techniques and the
reprocessing of traumatic events. The Eye Movement Desensitization and Reprocessing
Integrative Group Treatment Protocol will be composed of 4 sessions of 120 minutes each.
Arm group label:
Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol
Intervention type:
Other
Intervention name:
Treatment As Usual
Description:
Treatment As Usual condition will receive only standard support.
Arm group label:
Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol
Arm group label:
Treatment As Usual group
Summary:
Caregivers of pediatric brain tumor survivors may develop high levels of psychological
distress, mostly depression and anxiety, with effects comparable to those of a traumatic
event. Several studies suggest that Eye Movement Desensitization and Reprocessing could
be a promising treatment in similar clinical populations (i.e. adults with brain tumor),
but it has never been used for caregivers of pediatric brain tumor. The aims of the
present study will be to test the feasibility of the Eye Movement Desensitization and
Reprocessing Integrative Group Treatment Protocol for caregivers of pediatric brain tumor
survivors in a clinical setting and to evaluate its effectiveness in decreasing the
psychological distress in this population. The study will be monocentric, and with two
parallel branches: the Eye Movement Desensitization and Reprocessing Integrative Group
Treatment Protocol group, who will receive a 4-session treatment, versus the Treatment as
Usual condition, who will receive standard support. Emotional distress will be measured
before the treatment, immediately after the end of it, and two months later (follow-up),
by means of several clinical scales. Twenty-four subjects will be recruited for each
group (caregivers and controls). Statistical analysis will be performed to test the
effect of the intervention. If a positive outcome occurs, it could offer preliminary
results about the validity of the Eye Movement Desensitization and Reprocessing in
treating this population's difficulties.
Detailed description:
Pediatric cancer is a stressful life event, with a huge impact both on the diagnosed
children and on their parents, comparable to that of a traumatic event. Caregivers of
pediatric brain tumor survivors show several psychological difficulties, such as symptoms
of anxiety, depression, and post-traumatic stress disorder. The presence of psychological
distress throughout the oncological path of the child causes a long-term high burden
impact, leading to an increased need for psychological support from the caregivers.
The Eye Movement Desensitization and Reprocessing has never been used for caregivers of
pediatric brain tumor: neither individual nor Integrative Group Treatment Protocol.
Hence, the aims of the present study are: (1) to test the feasibility of the Eye Movement
Desensitization and Reprocessing Integrative Group Treatment Protocol for caregivers of
patients with pediatric brain tumor in a clinical setting; (2) to evaluate whether Eye
Movement Desensitization and Reprocessing Integrative Group Treatment Protocol is
effective in decreasing psychological distress in caregivers.
Several studies suggest that Eye Movement Desensitization and Reprocessing could be a
promising treatment for psychological distress, given the existing literature on
caregivers of adult patients with brain tumor or dementia.
Design: The study will be monocentric, with two parallel branches, thus conforming to a
Randomized Group Treatment Trial: Eye Movement Desensitization and Reprocessing
Integrative Group Treatment Protocol (those who will receive Eye Movement Desensitization
and Reprocessing treatment plus the standard support) versus Treatment As Usual condition
(those who will receive only standard support). The assessment will be performed at the
moment of recruitment (T0), after the intervention for the Eye Movement Desensitization
and Reprocessing Integrative Group Treatment Protocol group and after 1 month for the
Treatment As Usual condition (T1), and for both 2 months after T1 (T2).
Participants: Pediatric brain tumor caregivers and controls (24 subjects in each, 48
subjects in total) will be recruited at La Nostra Famiglia, IRCCS E. Medea, Bosisio
Parini (LC), Italy. Inclusion criteria: being the primary caregivers of a patient with a
diagnosis of brain tumor, with evidence of one or more traumatic events causing trauma
related symptoms (Impact of Event Scale-Revised > 0, and Subjective Units of Distress >
5); being fluent in Italian and with at least three years of education. Exclusion
criteria: Evidence of severe psychiatric disorders. Block randomization will be performed
to ensure a balance in sample size across groups over time.
Caregivers' assessment will include: a data form to collect clinical and
socio-demographic features (age, gender, educational level, occupation, type of pediatric
brain tumor, treatments ...), a feasibility questionnaire (only for the feasibility
study), the Impact of Event Scale-Revised, the Subjective Units of Distress, the
State-Trait Anxiety Inventory, the Beck Depression In-ventory, the Parenting Stress
Index, the Caregiver Burden Inventory, and the Family Assessment Device 3.
Intervention: An Eye Movement Desensitization and Reprocessing psychotherapist will hold
the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol
sessions, dedicated to psychoeducation, imagery exercises, stabilization techniques and
the reprocessing of traumatic events. The Eye Movement Desensitization and Reprocessing
Integrative Group Treatment Protocol will be composed of 4 sessions of 120 minutes each.
The number of the sessions has been chosen referring to the literature and based on the
length of the hospitalization in the Institute. In the case of an emergency (e.g.
increased number of Covid-19 cases), groups can also be held online. Supervision by an
Eye Movement Desensitization and Reprocessing practitioner will be requested.
Analyses: (i) Spearman's correlations to test the relationship between clinical and
socio-demographical variables; (ii) A series of generalized linear mixed models with
clinical variables (outcomes of the psychological tests) as dependent variables, random
intercept (grouped by subject) and with time (T0 versus T1 versus T2) and branch (Eye
Movement Desensitization and Reprocessing Integrative Group Treatment Protocol versus
Treatment As usual) as fixed effect predictors to test the intervention.
If a decrease in the psychological symptoms occurs, it could offer preliminary results
about the validity of the Eye Movement Desensitization and Reprocessing in alleviating
the difficulties caregivers have in caring for pediatric BT survivor, easing the burden
of an oncological disease with an unpredictable progression. Possible limitations of the
study could include dropouts, the need for a wider sample for more rigorous results or a
longer-term assessment (i.e. 6 months after the end of Eye Movement Desensitization and
Reprocessing Integrative Group Treatment Protocol ) to evaluate the stabilization of the
positive effects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- being the primary caregivers of a patient with a diagnosis of brain tumor,
- evidence of one or more traumatic events causing trauma related symptoms (Impact of
Event Scale-Revised > 0, and Subjective Units of Distress > 5);
- being fluent in Italian
- with at least three years of education.
Exclusion Criteria:
- Evidence of severe psychiatric disorders.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCSEMedea
Address:
City:
Bosisio Parini
Zip:
23842
Country:
Italy
Status:
Recruiting
Start date:
March 10, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
IRCCS Eugenio Medea
Agency class:
Other
Source:
IRCCS Eugenio Medea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06339814
