Randomized Controlled Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With Primary Biliary Cholangitis in Women (CBP-HOPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- PBC-40 questionaire
研究概览
简要总结
Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk. To treat fatigue in PBC, only medical treatments have been tested with limited efficacy or serious sides' effects. In other diseases, mostly cancer, psychological interventions showed efficacy on fatigue decrease. Most interventions consist in psychoeducation with: education about fatigue, development of self-care or coping techniques, activity management and learning to balance between activities and rest. Hypnosis, which consists in a body work for psycho-therapeutic use (e.g., through imagination), has also shown promising results. Moreover, psychological intervention efficacy seems to be influenced by patients' characteristics, such as personality. Therefore, the first aim of the present single-center randomized controlled phase 2 trial is to assess the efficacy of a psycho educational intervention and a hypnosis intervention on PBC patients' fatigue to demonstrate that both psychoeducational and hypnosis interventions decrease patient fatigue.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women from 18 to 75 years old,
- •Diagnosis of primary biliary cholangitis (PBC) according to recognized criteria (EASL 2017),
- •Medically stable under treatment with UDCA initiated for at least 6 months, ie medically stable on the basis of liver biological parameters (no increase of more than 20% in bilirubin, ALP and transaminases) and absence of disabling pruritus (permanent and EVA> 6/10 or scratching lesions),
- •Presenting a significant level of fatigue (fatigue score on PBC-40>= 33),
- •Understanding the French language,
- •Availability and ability of the patient to access an internet network terminal to answer the online questionnaires of the study,
- •Signed consent form.
排除标准
- •Presence of cirrhosis with a Child-Pugh B or C,
- •Presence of disabling pruritus (permanent, or EVA>= 7/10 in the last 3 weeks, or objectivable scratching skin lesions),
- •Patient on liver transplantation waiting list or total bilirubin> 50 μmol / L (3 mg / dL), or recent complication (<6 months) of cirrhosis (ascites, hepatic encephalopathy, rupture bleeding) of esophageal varices),
- •Untreated depressive disorder,
- •Any comorbidity not medically controlled (i.e. all dosage changes <3 months due to a control of the associated pathology deemed insufficient by the referring physician) or life-threatening in the medium term (within 2 years).
- •Psychiatric disorder modifying the relationship to the reality
研究组 & 干预措施
Control Group (CG)
Patients assigned to no intervention
Hypnosis intervention Group (EG-HYP)
Patients assigned to hypnosis intervention
干预措施: Hypnosis intervention (Behavioral)
Psychoeducational Intervention Group (EG-EDU)
Patients assigned to psychoeducational intervention
干预措施: Psychoeducational Intervention (Behavioral)
结局指标
主要结局
PBC-40 questionaire
时间窗: At month 3
次要结局
- Hospital Anxiety and Depression Scale (HADS) (4)(At month 6)
- Hospital Anxiety and Depression Scale (HADS) (2)(At week 5)
- Hospital Anxiety and Depression Scale (HADS) (3)(At month 3)
- Pittsburg Sleep Quality Inventory (PSQI) (3)(At month 3)
- Pittsburg Sleep Quality Inventory (PSQI) (4)(At month 6)
- Epworth Sleeping Scale (ESS) (1)(At Day 0)
- Epworth Sleeping Scale (ESS) (2)(At week 5)
- Epworth Sleeping Scale (ESS) (3)(At month 3)
- Epworth Sleeping Scale (ESS) (4)(At month 6)
- Hospital Anxiety and Depression Scale (HADS) (1)(At Day 0)
- Short Form Health Survey (SF36) (1)(At Day 0)
- Short Form Health Survey (SF36) (2)(At week 5)
- Short Form Health Survey (SF36) (3)(At month 3)
- Short Form Health Survey (SF36) (4)(At month 6)
- Multidimensional fatigue inventory (MFI) (1)(At Day 0)
- Multidimensional fatigue inventory (MFI) (2)(At week 5)
- Multidimensional fatigue inventory (MFI) (3)(At month 3)
- Multidimensional fatigue inventory (MFI) (4)(At month 6)
- PBC-40 questionaire (1)(At Day 0)
- PBC-40 questionaire (2)(At week 5)
- PBC-40 questionaire (3)(At month 6)
- Pittsburg Sleep Quality Inventory (PSQI) (1)(At Day 0)
- Pittsburg Sleep Quality Inventory (PSQI) (2)(At week 5)