Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339814
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-20
Brief Title:
Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol Applied to Caregivers of Children With Pediatric Brain Tumor a Feasibility Study and a Pilot Randomized Group Treatment Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 populations 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 eg 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 Spearmans 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 ie 6 months after the end of Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol to evaluate the stabilization of the positive effects
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 eg 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 Spearmans 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 ie 6 months after the end of Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol to evaluate the stabilization of the positive effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None