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