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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Impact of Event Scale-Revised-Hyperarousal score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Evidence of severe psychiatric disorders.
结局指标
主要结局
Impact of Event Scale-Revised-Hyperarousal score
时间窗: 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
时间窗: 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.
Beck Depression Inventory-Total score
时间窗: 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.
Stress Index for Parents of Adolescents-Social alienation score
时间窗: 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
State-Trait Anxiety Inventory-State anxiety score
时间窗: 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
时间窗: 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.
Stress Index for Parents of Adolescents-Total stress score
时间窗: 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.
Impact of Event Scale-Revised-Total score
时间窗: 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
时间窗: 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
时间窗: 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.
Parenting Stress Index-Total score
时间窗: 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-Dysfunctional interaction score
时间窗: 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-Relationship with spouse/partner score
时间窗: 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-Incompetence/guilt score
时间窗: 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-Physical burden score
时间窗: 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.
Family Assessment Device 3-Communication score
时间窗: 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-Affective Involvement score
时间窗: 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-General Functioning score
时间窗: 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.
Parenting Stress Index-Parental stress score
时间窗: 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
时间窗: 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-Life restrictions score
时间窗: 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
Caregiver Burden Inventory-Time-dependence burden score
时间窗: 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
时间窗: 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 Responsiveness score
时间窗: 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.
Caregiver Burden Inventory-Developmental burden score
时间窗: 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-Social burden score
时间窗: 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
时间窗: 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-Roles score
时间窗: 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-Behavior Control score
时间窗: 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.
次要结局
未报告次要终点