Effect of EMDR for Reduction of Pain Interference in Children With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain interference
研究概览
简要总结
Children with sickle cell disease may experience frequent painful episodes. This, together with the traumatic experiences during a hospitalization, can lead to the development of posttraumatic stress reactions. As the stress can trigger painful episodes (pain crisis) in children with sickle cell disease, the investigators think that treating these stress symptoms can reduce the pain-related problems in their lives. Eye Movement Desensitization and Reprocessing (EMDR) is proven to be an effective trauma treatment for posttraumatic stress disorder. Research studies show that EMDR can reduce pain in adults. The investigators want to study now if EMDR effective is in reducing pain-related problems in children with sickle cell disease.
详细描述
Objective
The primary objective of this study is to investigate the efficacy of EMDR therapy in reducing pain interference in the lives of children with SCD. Secondary objectives are to study the efficacy of EMDR in reducing PTSD symptoms, anxiety, depressive symptoms, physical complaints (low mobility), frequency and severity of pain, use of pain medication, and number of days absent from school. Themes of pain and trauma-related memories and feasibility of EMDR therapy for this population will also be explored.
Study design: In this single-center randomized controlled trial (RCT) patients (aged 6-18 years) with SCD and clinically relevant scores on PROMIS pain interference will be randomized into an intervention group and waiting list control group. Measurements will be done for the complete study population at inclusion (T0). In the intervention group, measurements will be done 2 weeks (T1i) and 3 months (T2i) after the end of EMDR sessions. Eight weeks after inclusion (T1c) will be performed for participants in the waiting list control group just before they receive EMDR treatment, and they are asked to complete measurements, 2 weeks (T1.1c) and 3 months after the end of EMDR sessions (T2c).
Intervention: After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. The waiting list control group will wait 9 weeks before starting EMDR therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of SCD
- •Age between 6 and 18 years old
- •Elevated pain interference scores: Reporting above the clinical cut-off T-score of 49 on PROMIS Pain Interference (parent-proxy version for children from 6-7 years and self-report version for children from 8 years).
- •Having sufficient knowledge of the Dutch or English languages to complete the assessments
排除标准
- •Undergone successful stem cell transplantation
- •Pregnant adolescents
- •Current unsafety that is likely to interfere with psychological therapy for example ongoing domestic violence
- •Major interfering acute medical or psychiatric condition, such as psychosis, substance dependence, current severe self-harm or high risk for suicide requiring immediate treatment
- •Receiving psychological (trauma) treatment by another therapist at the same time
- •IQ estimated to be < 80 based on information contained in the medical history or information from educational services/school
研究组 & 干预措施
EMDR intervention group
Measurements will be done for the complete study population at inclusion (T0). Participants randomized to the intervention group will start the EMDR therapy as soon as possible. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. In the intervention group, measurements will be done 2 weeks (T1i) and 3 months (T2i) after the end of EMDR sessions.
干预措施: Eye Movement Desensitization and Reprocessing (EMDR) (Other)
Wait-list control group
Measurements will be done for the complete study population at inclusion (T0). Participants randomized to wait-list control group will wait for 9 weeks to start the therapy. Eight weeks after inclusion (T1c) will be performed for participants in the wait-list control group, just before they receive EMDR treatment. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. Participants of the wait-list control group are asked to complete measurements 2 weeks (T1.1c) and 3 months after the end of EMDR sessions (T2c).
干预措施: Eye Movement Desensitization and Reprocessing (EMDR) (Other)
结局指标
主要结局
Pain interference
时间窗: Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)
The PROMIS Short Form - Pain Interference 8a for measuring Pain Interference will be used. The PROMIS Pain Interference questionnaire assesses the pain impact on relevant aspects of one's life. This includes the extent to which pain affects social, cognitive, emotional, physical, and recreational activities. It also incorporates items probing sleep and enjoyment in life. The questionnaire assesses pain interference over the past seven days (recall period). A higher PROMIS T-score represents more pain interference. This scale ranges from 0 to 100 points. In his dissertation, Luijten reports that the general Dutch pediatric population reports a mean score of 39 points with a standard deviation of 10 points. Therefore, T-scores of 49 and above represent a (sub)clinical level of functioning. On a previous study from our group, children with severe SCD phenotype (n= 36) reported a mean score of 52.73 points (SD= 12.72), while the ones with less severe SCD phenotype (n= 54).
次要结局
- PTSD symptoms(Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2))
- Anxiety(Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2))
- Depressive symptoms(Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2))
- Physical complaints (low moblity)(Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2))
- Pain frequency(Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2))
- Pain severity(Inclusion (T0), before and after each EMDR session, 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2).)
- Use of pain medication(Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2).)
- School absence(Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2))
研究者
Karin Fijnvandraat
prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)