Caregiver BurdenNCT06339814
Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients
A study testing Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol and Treatment As Usual in people with Caregiver Burden, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Evidence of severe psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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 (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
- Caregiver Burden
- Being tested
- Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol, Treatment As Usual
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing Integrative Group Treatment ProtocolOther
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 UsualOther
Treatment As Usual condition will receive only standard support.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start10 Mar 2023
- Primary completionOct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Chiara Oprandi, Principal investigator, IRCCS Eugenio Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339814
- Sponsor's protocol ID
- 05/23-CE
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06339814
- Acronym / sponsor ID
- 05/23-CE
- Conditions
- Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol | Experimental | Other: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol, Other: Treatment As UsualEye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol will receive Eye Movement Desensitization and Reprocessing treatment plus the standard support |
| Treatment As Usual group | Active comparator | Other: Treatment As UsualTreatment As Usual group will receive only standard support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Evidence of severe psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing Integrative Group Treatment ProtocolAn 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. | Other | Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol |
| Treatment As UsualTreatment As Usual condition will receive only standard support. | Other | Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol, Treatment As Usual group |
Primary outcome
Impact of Event Scale-Revised-Total score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Impact of Event Scale-Revised-Intrusion score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Impact of Event Scale-Revised-Avoidance score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Impact of Event Scale-Revised-Hyperarousal score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Subjective Units of Distress-Total Score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
State-Trait Anxiety Inventory-State anxiety score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
State-Trait Anxiety Inventory-Trait anxiety score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Beck Depression Inventory-Total score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Parenting Stress Index-Total score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Parenting Stress Index-Parental stress score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Parenting Stress Index-Dysfunctional interaction score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Parenting Stress Index-Hard child score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Stress Index for Parents of Adolescents-Total stress score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Stress Index for Parents of Adolescents-Life restrictions score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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
Stress Index for Parents of Adolescents-Relationship with spouse/partner score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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
Stress Index for Parents of Adolescents-Social alienation score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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
Stress Index for Parents of Adolescents-Incompetence/guilt score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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
Caregiver Burden Inventory-Time-dependence burden score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Caregiver Burden Inventory-Developmental burden score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Caregiver Burden Inventory-Physical burden score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Caregiver Burden Inventory-Social burden score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Caregiver Burden Inventory-Emotional burden score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-Problem Solving score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-Communication score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-Roles score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-Affective Responsiveness score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-Affective Involvement score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-Behavior Control score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Family Assessment Device 3-General Functioning score
Time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Chiara Oprandi principal investigator
IRCCS Eugenio Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol and Treatment As Usual in people with Caregiver Burden, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Chiara Oprandi (+39 340 05 18 917, chiara.oprandi@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Event Scale-Revised-Total score (time frame: at the moment of recruitment (T0), after 1 month (T1), and 2 months after T1 (T2) for both groups). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.