protocolSection identificationModule nctId: NCT06339814, orgStudyIdInfo id: 05/23-CE, briefTitle: Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Caregiver Burden, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol, interventions name: Treatment As Usual, outcomesModule primaryOutcomes measure: Impact of Event Scale-Revised-Total score, primaryOutcomes measure: Impact of Event Scale-Revised-Intrusion score, primaryOutcomes measure: Impact of Event Scale-Revised-Avoidance score, primaryOutcomes measure: Impact of Event Scale-Revised-Hyperarousal score, primaryOutcomes measure: Subjective Units of Distress-Total Score, primaryOutcomes measure: State-Trait Anxiety Inventory-State anxiety score, primaryOutcomes measure: State-Trait Anxiety Inventory-Trait anxiety score, primaryOutcomes measure: Beck Depression Inventory-Total score, primaryOutcomes measure: Parenting Stress Index-Total score, primaryOutcomes measure: Parenting Stress Index-Parental stress score, primaryOutcomes measure: Parenting Stress Index-Dysfunctional interaction score, primaryOutcomes measure: Parenting Stress Index-Hard child score, primaryOutcomes measure: Stress Index for Parents of Adolescents-Total stress score, primaryOutcomes measure: Stress Index for Parents of Adolescents-Life restrictions score, primaryOutcomes measure: Stress Index for Parents of Adolescents-Relationship with spouse/partner score, primaryOutcomes measure: Stress Index for Parents of Adolescents-Social alienation score, primaryOutcomes measure: Stress Index for Parents of Adolescents-Incompetence/guilt score, primaryOutcomes measure: Caregiver Burden Inventory-Time-dependence burden score, primaryOutcomes measure: Caregiver Burden Inventory-Developmental burden score, primaryOutcomes measure: Caregiver Burden Inventory-Physical burden score, primaryOutcomes measure: Caregiver Burden Inventory-Social burden score, primaryOutcomes measure: Caregiver Burden Inventory-Emotional burden score, primaryOutcomes measure: Family Assessment Device 3-Problem Solving score, primaryOutcomes measure: Family Assessment Device 3-Communication score, primaryOutcomes measure: Family Assessment Device 3-Roles score, primaryOutcomes measure: Family Assessment Device 3-Affective Responsiveness score, primaryOutcomes measure: Family Assessment Device 3-Affective Involvement score, primaryOutcomes measure: Family Assessment Device 3-Behavior Control score, primaryOutcomes measure: Family Assessment Device 3-General Functioning score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCSEMedea, status: RECRUITING, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, geoPoint lat: 45.80075, lon: 9.29, hasResults: False