Effectiveness of Two Psychological Interventions for Prevention and Management of Pain, Emotional Regulation and Promotion of Quality of Life in People With Haemophilia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to evaluate the relative effectiveness of two psychological interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and managing pain, regulating emotional state and improving quality of life in Portuguese PWH.
详细描述
22 (People with Haemophilia) PWH will be included in each group (Hypnosis, CBT and control-no intervention) (total=66). Sample size was calculated using G*Power 3.1.4 and considering the following assumptions: to perform a one-way ANOVA with fixed effects, a large effect size (f =0.4), a significance level (α - type I error) of 0.05 and a statistical power (1-β - type II error) of 0.80.
The patients will be approached by clinicians of the Immunohaemotherapy Department and the psychologists for the explanation of the study, confidentiality and voluntary nature of participation. Patients who agree to participate will be asked to read and sign the Informed Consent document. Afterwards, the first assessment moment will take place in order to get a baseline assessment of each patient (T0: pre-test). Subsequently, the blind randomization to one of the 3 conditions will occur and the 4 individual intervention sessions will be scheduled, occurring in a weekly basis (90 minutes per session).
The post-test assessment (T1) takes place one week after the last intervention session (in the 5th week), and the follow-up assessments (T2, T3 and T4) will occur subsequently at 3 months, 6 months and one year post-intervention.
A physiological assessment will be performed at T1, T2 and T4. This will be performed through the collection of blood samples in order to achieve a systemic evaluation of pro-inflammatory and anti-inflammatory cytokines. A CBC (Complete Blood Count) with White Blood Count and C Reactive Protein (CRP) analysis will also be performed. Upon arrival at the Immunohaemotherapy Department (between 9:30 am and 1:30 pm), patients will undergo sample blood collection and EDTA-samples will be transported immediately to the lab.
In the lab, blood samples are centrifuged 15 minutes at 3.000 rpm, and plasma aliquoted and stored in a freezer at -80 ºC, until further analysis. Plasma levels of cytokines (IL-6, IL-1β, TNF-α, IL-10) are assayed in duplicate using ultra-sensitive multiplex human ELISA kits (Life Technologies®).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Mild pr severe Haemophilia A or B
- •Age of 18 or older
- •Ability to write and read
排除标准
- •Other comorbid life threatening diseases, such as cancer
- •Neurological or psychiatric deficits
- •Acquired Haemophilia
研究组 & 干预措施
Hypnosis
Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
干预措施: Hypnosis (Behavioral)
Cognitive-Behavioral Therapy
Cognitive Behavioral Therapy for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Control Group
No psychological intervention - standard Haemophilia care
结局指标
主要结局
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
时间窗: 1 week post-intervention
Pain intensity at 3 months as assessed by NRS
时间窗: 3 months post-intervention
Pain intensity at 6 months as assessed by NRS
时间窗: 6 months post-intervention
Pain intensity at 12 months as assessed by NRS
时间窗: 12 months post-intervention
次要结局
- Anxiety at 3 months as assessed by PROMIS-Anxiety Short Form v1.0(3 months)
- Anxiety at 6 months as assessed by PROMIS-Anxiety Short Form v1.0(6 months)
- Analgesic intake in the previous month, at 1 week(1 week)
- Analgesic intake in the previous month, at 3 months(3 months)
- Analgesic intake in the previous month, at 6 months(6 months)
- Analgesic intake in the previous month, at 12 months(12 months)
- Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol(1 week)
- HRQOL at 3 months as assessed by A36Hemofilia-Qol(3 months)
- HRQOL at 6 months as assessed by A36Hemofilia-Qol(6 months)
- HRQOL at 12 months as assessed by A36Hemofilia-Qol(12 months)
- Haemophilia related functional limitations at 1 week as assessed by Haemophilia Activities List (HAL)(1 week)
- Haemophilia related functional limitations at 3 months as assessed by HAL(3 months)
- Haemophilia related functional limitations at 6 months as assessed by HAL(6 months)
- Anxiety at 1 week as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form v1.0(1 week)
- Haemophilia related functional limitations at 12 months as assessed by HAL(12 months)
- Anxiety at 12 months as assessed by PROMIS-Anxiety Short Form v1.0(12 months)
- Depression at 1 week as assessed by PROMIS-Depression Short Form v1.0(1 week)
- Depression at 3 months as assessed by PROMIS-Depression Short Form v1.0(3 months)
- Depression at 6 months as assessed by PROMIS-Depression Short Form v1.0(6 months)
- Depression at 12 months as assessed by PROMIS-Depression Short Form v1.0(12 months)
- Pain Catastrophizing at 1 week as assessed by Coping Strategies Questionnaire (CSQ) Catastrophizing Subscale(1 week)
- Pain Catastrophizing at 3 months as assessed by CSQ Catastrophizing Subscale(3 months)
- Pain Catastrophizing at 6 months as assessed by CSQ Catastrophizing Subscale(6 months)
- Pain Catastrophizing at 12 months as assessed by CSQ Catastrophizing Subscale(12 months)
- Illness Perception (Personal Control) at 1 week as assessed by Revised Illness Perception Questionnaire (IPQ-R)(1 week)
- Illness Perception (Emotional Representation) at 1 week as assessed by IPQ-R(1 week)
- Illness Perception (Personal Control) at 3 months as assessed by IPQ-R(3 months)
- Illness Perception (Emotional Representation) at 3 months as assessed by IPQ-R(3 months)
- Illness Perception (Personal Control) at 6 months as assessed by IPQ-R(6 months)
- Illness Perception (Emotional Representation) at 6 months as assessed by IPQ-R(6 months)
- Number of joint bleeds in the previous month, at 1 week(1 week)
- Number of joint bleeds in the previous month, at 3 months(3 months)
- Number of joint bleeds in the previous month, at 6 months(6 months)
- Number of joint bleeds in the previous month, at 12 months(12 months)
- Illness Perception (Personal Control) at 12 months as assessed by IPQ-R(12 months)
- Illness Perception (Emotional Representation) at 12 months as assessed by IPQ-R(12 months)
- Replacement factor (VIII/IX) consumption in the previous month, at 1week(1 week)
- Replacement factor (VIII/IX) consumption in the previous month, at 3 months(3 months)
- Replacement factor (VIII/IX) consumption in the previous month, at 6 months(6 months)
- Replacement factor (VIII/IX) consumption in the previous month, at 12 months(12 months)
- Pettersson Score at 3 months(3 months)
- Pettersson Score at 12 months(12 months)
- Gilbert Score at 3 months(3 months)
- Gilbert Score at 12 months(12 months)
- IL-1β Cytokine at 12 months(12 months)
- IL-6 Cytokine at 3 months(3 months)
- IL-6 Cytokine at 12 months(12 months)
- IL-1β Cytokine at 6 months(6 months)
- C Reactive Protein at 6 months(6 months)
- C Reactive Protein at 12 months(12 months)
- IL-10 Cytokine at 6 months(6 months)
- IL-10 Cytokine at 12 months(12 months)
- TNF-α Cytokine at 6 months(6 months)
- TNF-α Cytokine at 12 months(12 months)
研究者
Patrícia Ribeiro Pinto
Post-doctoral fellow
University of Minho