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

NCT06339814 | Recruiting

• 1 other identifier: 05/23-CE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 (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

Outcome Measures

Primary Outcomes (29)

• Impact of Event Scale-Revised-Total score

  The Impact of Event Scale - Revised was designed as a measure of post-traumatic stress disorder symptoms, and is a short, easily administered self-report questionnaire. It can be used for repeated measurements over time to monitor progress and is best used for recent and specific traumatic events. Minimum-maximum value:0-88. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Impact of Event Scale-Revised-Intrusion score

  The Impact of Event Scale - Revised was designed as a measure of post-traumatic stress disorder symptoms, and is a short, easily administered self-report questionnaire. It can be used for repeated measurements over time to monitor progress and is best used for recent and specific traumatic events. Minimum-maximum value:0-32;maximum mean score: 4. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Impact of Event Scale-Revised-Avoidance score

  The Impact of Event Scale - Revised was designed as a measure of post-traumatic stress disorder symptoms, and is a short, easily administered self-report questionnaire. It can be used for repeated measurements over time to monitor progress and is best used for recent and specific traumatic events. Minimum-maximum value:0-32;maximum mean score: 4. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Impact of Event Scale-Revised-Hyperarousal score

  The Impact of Event Scale - Revised was designed as a measure of post-traumatic stress disorder symptoms, and is a short, easily administered self-report questionnaire. It can be used for repeated measurements over time to monitor progress and is best used for recent and specific traumatic events. Minimum-maximum value:0-24;maximum mean score: 4. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Subjective Units of Distress-Total Score

  The Subjective Units of Distress Scale is a tool for measuring the intensity of feelings and other internal experiences, such as anxiety, anger, agitation, stress or other painful feelings. The score ranges between 0 (no disturbance) and 10 (maximum perceived disturbance). Minimum-maximum value:0-10. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• State-Trait Anxiety Inventory-State anxiety score

  The State-Trait Anxiety Inventory is a 40-item self-report scale that assesses separate dimensions of "state" and "trait" anxiety. Examples of what the the tool measures include feelings of apprehension, tension, nervousness, and worry. Minimum-maximum value: 20-80. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• State-Trait Anxiety Inventory-Trait anxiety score

  The State-Trait Anxiety Inventory is a 40-item self-report scale that assesses separate dimensions of "state" and "trait" anxiety. Examples of what the the tool measures include feelings of apprehension, tension, nervousness, and worry. Minimum-maximum value: 20-80. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Beck Depression Inventory-Total score

  The Beck Depression Inventory is a 21-item, multiple-choice inventory. Respondents are asked to rate each item based on four response choices according to the severity of the symptoms, ranging from the absence of a symptom to an intense level, during the past week. Minimum-maximum value: 0-63. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Parenting Stress Index-Total score

  The Parenting Stress Index is used to measure the relative stress in the parent-child relationship. It can be used for parents of children up to 12 years. Minimum-maximum value: 36-180. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Parenting Stress Index-Parental stress score

  The Parenting Stress Index is used to measure the relative stress in the parent-child relationship. It can be used for parents of children up to 12 years. Minimum-maximum value: 12-60. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Parenting Stress Index-Dysfunctional interaction score

  The Parenting Stress Index is used to measure the relative stress in the parent-child relationship. It can be used for parents of children up to 12 years. Minimum-maximum value: 12-60. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Parenting Stress Index-Hard child score

  The Parenting Stress Index is used to measure the relative stress in the parent-child relationship. It can be used for parents of children up to 12 years. Minimum-maximum value: 12-60. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Stress Index for Parents of Adolescents-Total stress score

  The Stress Index for Parents of Adolescents is a screening and diagnostic instrument that identifies areas of stress in parent-adolescent interactions, allowing examination of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. It can be used for parents of children between 11 and 19 years. Minimum-maximum value: 112-560. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Stress Index for Parents of Adolescents-Life restrictions score

  The Stress Index for Parents of Adolescents is a screening and diagnostic instrument that identifies areas of stress in parent-adolescent interactions, allowing examination of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. It can be used for parents of children between 11 and 19 years. Minimum-maximum value: 10-50. Higher scores mean worse outcome

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Stress Index for Parents of Adolescents-Relationship with spouse/partner score

  The Stress Index for Parents of Adolescents is a screening and diagnostic instrument that identifies areas of stress in parent-adolescent interactions, allowing examination of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. It can be used for parents of children between 11 and 19 years. Minimum-maximum value: 9-45. Higher scores mean worse outcome

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Stress Index for Parents of Adolescents-Social alienation score

  The Stress Index for Parents of Adolescents is a screening and diagnostic instrument that identifies areas of stress in parent-adolescent interactions, allowing examination of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. It can be used for parents of children between 11 and 19 years. Minimum-maximum value: 7-35. Higher scores mean worse outcome

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Stress Index for Parents of Adolescents-Incompetence/guilt score

  The Stress Index for Parents of Adolescents is a screening and diagnostic instrument that identifies areas of stress in parent-adolescent interactions, allowing examination of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. It can be used for parents of children between 11 and 19 years. Minimum-maximum value: 8-40. Higher scores mean worse outcome

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Caregiver Burden Inventory-Time-dependence burden score

  The Caregiver Burden Inventory comprises 24 closed questions to assess the physical, psychological, emotional, social and financial problems experienced by family caregivers. Minimum-maximum value: 0-20. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Caregiver Burden Inventory-Developmental burden score

  The Caregiver Burden Inventory comprises 24 closed questions to assess the physical, psychological, emotional, social and financial problems experienced by family caregivers. Minimum-maximum value: 0-20. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Caregiver Burden Inventory-Physical burden score

  The Caregiver Burden Inventory comprises 24 closed questions to assess the physical, psychological, emotional, social and financial problems experienced by family caregivers. Minimum-maximum value: 0-16. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Caregiver Burden Inventory-Social burden score

  The Caregiver Burden Inventory comprises 24 closed questions to assess the physical, psychological, emotional, social and financial problems experienced by family caregivers. Minimum-maximum value: 0-20. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Caregiver Burden Inventory-Emotional burden score

  The Caregiver Burden Inventory comprises 24 closed questions to assess the physical, psychological, emotional, social and financial problems experienced by family caregivers. Minimum-maximum value: 0-20. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-Problem Solving score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-24. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-Communication score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-40. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-Roles score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-44. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-Affective Responsiveness score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-24. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-Affective Involvement score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-28. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-Behavior Control score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-36. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

• Family Assessment Device 3-General Functioning score

  The McMaster Family Assessment Device is a 60-item questionnaire that measures an individual's perceptions of his/her family. Minimum-maximum value: 6-48. Higher scores mean worse outcome.

  at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups

Study Arms (2)

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol

EXPERIMENTAL

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

Other: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol; Other: Treatment As Usual

Treatment As Usual group

ACTIVE COMPARATOR

Treatment As Usual group will receive only standard support

Other: Treatment As Usual

Interventions

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol 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.

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol

Treatment As Usual OTHER

Treatment As Usual condition will receive only standard support.

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol; Treatment As Usual group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Evidence of severe psychiatric disorders.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCSEMedea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Maria Chiara Oprandi

  IRCCS Eugenio Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Chiara Oprandi

CONTACT

+39 340 05 18 917; chiara.oprandi@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 1, 2024
• Study Start: March 10, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 30, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)