Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission

NCT05591625

Post Traumatic Stress Disorder Critical Illness Eye Movement Desensitisation and Reprocessing +1 more

RECRUITING NA

Eye-Movement Desensitization and Reprocessing in the ED and Post-Traumatic Syndrome

NCT03194386

Post-Traumatic Stress Disorder

COMPLETED NA

Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]

NCT04431765

Post-traumatic Stress Disorder

RECRUITING NA

Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women

NCT03416764

Posttraumatic Stress Disorder (PTSD)

UNKNOWN NA

Reconsolidation and EMDR

NCT02572830

PTSD

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caregiver Burden

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol will receive Eye Movement Desensitization and Reprocessing treatment plus the standard support

Group Type EXPERIMENTAL

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol

Intervention Type OTHER

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.

Treatment As Usual

Intervention Type OTHER

Treatment As Usual condition will receive only standard support.

Treatment As Usual group

Treatment As Usual group will receive only standard support

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type OTHER

Treatment As Usual condition will receive only standard support.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol

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.

Intervention Type OTHER

Treatment As Usual

Treatment As Usual condition will receive only standard support.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.