Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Severity of abdominal symptoms
研究概览
简要总结
Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay between the gut and the central nervous system. Several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. Recent surveys have shown that DGBI affect up to 40 % of the general population.
Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. However, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions.
OBJECTIVE: To determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with DGBI.
METHODOLOGY: After development of a program of psycho-education on DGBI using interactive immersion by means of virtual reality (VR) a randomized clinical trial will be developed. Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient in the active treatment group a session of psychoeducation using specifically developed VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means VR). Patients in the placebo group willl take a placebo capsule daily.
OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6 months.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI (Body Mass Index) between 18.5-24.99, with variations of up to 15%.
- •Ability to understand instructions and follow protocol.
- •Access to internet network from usual residence.
排除标准
- •Previous history of abdominal surgery with the exception of appendectomy and herniorrhaphy.
- •Abuse of alcohol, tobacco or narcotics.
- •Medical evidence of organic gastrointestinal pathology, hepatopathy, endocrinopathy, heart disease or contagious disease, as well as major psychiatric disorder.
研究组 & 干预措施
Placebo
干预措施: Placebo (Behavioral)
Psychological intervention
干预措施: Psychological intervention (Behavioral)
结局指标
主要结局
Severity of abdominal symptoms
时间窗: 6 months
Changes from basal scores in the severity of abdominal symptoms will be calculated using the irritable bowel syndrome-symptom severity score (IBS-SSS), where score 0 is the lack of symptoms, and score 500 is maximal severity of symptoms.
次要结局
- IBS related Quality of life(6 weeks)
- Stress(6 weeks)
- Anxiety and depression(6 weeks)
- Somatic co-morbidities(6 weeks)
- Rectal sensitivity(6 weeks)
- Analysis of gut microbiota composition(6 weeks)