THE ROLE OF GUT-DIRECTED HYPNOTHERAPY IN RELAPSE PREVENTION FOR ULCERATIVE COLITI

肠道导向催眠疗法在预防溃疡性结肠炎复发中的作用

• 批准号: 7314862
• 负责人: LAURIE A KEEFER
• 金额: $ 19.63万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7314862
• 关键词: Adherence; Affect; Arousal; Attention; Behavioral; Caring; Characteristics; Chronic; Clinical; Clinical assessments; Condition; Daily; Disease; Disease Outcome; Disease remission; Drops; Eating; End Point; Enrollment; Evaluation; Exercise; Feces; Flare; Frequencies; Future; Goals; Hemorrhage; Hormones; Hypnotherapy; Inflammatory Bowel Diseases; Intervention; Life Style; Maintenance; Mesalamine; Methods; Numbers; Participant; Patients; Perceived quality of life; Pharmaceutical Preparations; Physicians; Physiological; Precipitating Factors; Process; Production; Psychological Stress; Quality of life; Randomized; Rate; Relapse; Resistance; Risk; Role; Self Care; Self Efficacy; Self Management; Severities; Severity of illness; Standards of Weights and Measures; Steroids; Stress; Symptoms; Techniques; Time; Ulcerative Colitis; Week; clinically significant; concept; coping; cost; day; demographics; diaries; disease characteristic; disorder control; disorder later incidence prevention; disorder risk; follow-up; immune function; improved; prevent; psychologic; psychological distress; rectal; size; stress management

DESCRIPTION (provided by applicant): Aim 1 is to determine whether gut-directed hypnotherapy, an established CAM intervention that targets psychological stress, is feasible and acceptable to patients with Ulcerative Colitis (UC). Aim 2 is to estimate effect sizes for gut-directed hypnotherapy on relapse prevention and other clinical disease outcomes in UC. This project is a step towards our long-term goal, which is to help patients with Inflammatory Bowel Diseases (IBD) employ behavioral self-management techniques in order to obtain better disease control, reduce the frequency, severity and duration of flare-ups and achieve improved quality of life. The introduction of maintenance medications has been critical for a portion of patients with respect to increasing time between flares, but relapse prevention methods are limited. IBD patients and their doctors cite stress as a common trigger for relapse. Gut-directed hypnotherapy may impact UC by improving adherence and attention to positive lifestyle factors and altering stress-related physiological and psychological processes that contribute to disease flare and quality of life. 88 UC patients in remission will be randomized to a) 8 weeks of gut directed hypnotherapy + standard care (HYP), b) 8 weeks time/attention control + standard care (TA) or c) standard care alone (SCA). Assessments are repeated at baseline, 8 weeks (post-treatment), 20 weeks, 36 weeks and 52 weeks. Aim 1 Endpoints: 1) proportion of patients who are retained over the trial period in comparison to those who did not complete/enter the trial. We expect that HYP will be feasible and acceptable to at least a subset of patients with inactive UC; 2) differences between participants who enroll and those who decline enrollment/drop-out on demographics, disease characteristics, adherence and perceived stress. We expect that there will be differences between groups: HYP > TA > SCA. Aim 2 Endpoints: 1) the proportion of participants in each treatment group that are still in remission at 52 weeks, as determined by daily symptom diaries and physician evaluation. We expect that HYP, when used in conjunction with standard care, may increase the proportion of patients who remain in remission at 1-year follow-up more than either TA or SCA, demonstrating proof of concept that hypnotherapy may positively impact risk of relapse; 2) mean number of days to relapse, characteristics of first flare, quality of life, perceived control, perceived stress and adherence: HY P>TA>SCA.

描述（由申请人提供）： 目的1是确定是否肠道定向催眠治疗，一个既定的CAM干预，针对心理压力，是可行的，并接受溃疡性结肠炎（UC）患者。目的2是估计肠道定向催眠疗法对UC复发预防和其他临床疾病结局的效果大小。 这个项目是朝着我们的长期目标迈出的一步，即帮助炎症性肠病患者 (IBD)采用行为自我管理技术，以获得更好的疾病控制，减少 发作的频率、严重程度和持续时间，并提高生活质量。引入 维持药物对于一部分患者来说是至关重要的， 复发，但预防复发的方法有限。IBD患者和他们的医生认为压力是一种常见的 复发的诱因肠道定向催眠治疗可能通过改善对以下方面的依从性和注意力来影响UC： 积极的生活方式因素和改变与压力相关的生理和心理过程， 疾病爆发和生活质量。88例缓解期UC患者将随机分配至a）8周肠道定向 催眠疗法+标准护理（HYP），B）8周时间/注意力控制+标准护理（TA）或c） 单独标准护理（SCA）。在基线、8周（治疗后）、20周、36周（治疗后） 周和52周。目的1终点：1）在试验期间保留的患者比例， 与未完成/进入试验的患者进行比较。我们预期油�地计划是可行的， 至少一部分非活动期UC患者可接受; 2）入组受试者之间的差异 以及那些在人口统计学、疾病特征、依从性和 感知压力我们预计各组之间会有差异：HYP > TA > SCA。目的2 终点：1）每个治疗组中在52周时仍处于缓解状态的参与者比例， 通过每日症状日记和医生评估确定。我们预计，当HYP用于 与标准治疗结合，可能会增加1年时保持缓解的患者比例 比TA或SCA更多的随访，证明催眠疗法可能积极的概念证据 影响复发风险; 2）复发平均天数、首次发作特征、生活质量 控制感、压力感与依从性的关系：HY P>TA>SCA。