Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- IBS-SSS at 8 Weeks
研究概览
简要总结
The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
详细描述
Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.
Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.
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
- 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
- •Male and female patients >=18 years old.
- •Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.
- •English proficiency (in order to understand use of the application.
- •Patient must be on a stable regimen for IBS for at least 30 days.
- •Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.
排除标准
- •Laboratory or imaging evidence of an alternative explanation of patient's symptoms.
- •Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application.
- •Patient already undergoing cognitive behavioral therapy.
- •Psychiatric hospitalization within 10 years.
- •Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.
- •Active (within the past 3 months) suicidal ideation.
- •Prisoners or other detained individuals.
- •Adults unable to consent.
- •Pregnant people.
结局指标
主要结局
IBS-SSS at 8 Weeks
时间窗: Baseline and at Week 8.
Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; \>300 = severe).
次要结局
- IBS-SSS at 24 Weeks(Baseline and at Week 24)
- Hospital Anxiety and Depression Scale (HADS) - Depression Score(Baseline, week 8 and week 24)
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Score(Baseline, week 8 and week 24)
- Cohen Perceived Stress Questionnaire (PSQ)(baseline, 24 weeks)
- Work and Social Adjustment Scale (WSAS)(Baseline, week 24)
- Subject's Global Assessment of Relief (SGA)(Baseline, Week 24)
- Work Productivity and Activity Impairment (WPAI) Questionnaire(Baseline, 8 weeks, 24 weeks)
- Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS(24 months)
研究者
Linda Nguyen
Clinical Professor
Stanford University