A Randomized Evaluation of Changes in Anxiety and Depression in Inflammatory Bowel Disease Patients Comparing Structured Mental Health Support to App Based Mental Health Support in Addition to Standard of Care Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Patient Health Questionnaire-9 (PHQ-9) Score
研究概览
简要总结
The purpose of this study is to test the impact of Healing Circuits™; a structured mental health support model on IBD patients. The eligible study participants will be randomly divided into two groups: 1. the group receiving structured mental health support with a social worker and 2. the group receiving structured mental health support via a self-directed online curriculum. Both groups will be receiving the same type of therapy, Healing Circuits™, but the group receiving the therapy via the online self-directed curriculum will be receiving the therapy mostly by web-based video instruction. The two groups will be evaluated over a period of 12 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet each of the following criteria for enrolment into the study:
- •Written informed consent must be obtained and documented.
- •Males and females between the ages of 18 and 75 years of age with documented diagnosis of IBD.
- •GAD7 and/or PHQ9 score of 10 -
- •Ability of subject to participate fully in all aspects of this clinical trial.
- •IBD patients who plan to have ongoing medical care at TIDHI.
排除标准
- •Subjects who exhibit any of the following conditions are to be excluded from the study:
- •Plan for change in systemically delivered IBD-related medical therapy in the 3 months after screening.
- •Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder.
- •Planned change in psychiatric medication, if any is being taken, within 3 months after screening.
- •History of illegal drug abuse (excluding marijuana) or alcohol abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures
研究组 & 干预措施
Sessions with a social worker based on Healing Circuits™ Methodology
干预措施: Healing Circuits™ sessions (Behavioral)
Online modules of a self-directed Healing Circuits™ curriculum
干预措施: self-directed Healing Circuits™ curriculum (Behavioral)
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: 3 months following initiation of Healing Circuits™
PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores range from 0 to 27, with higher scores indicating greater depression severity. This outcome will assess the mean difference in PHQ-9 scores between the one-on-one therapy and app-based therapy groups.
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score
时间窗: 3 months following initiation of Healing Circuits™
The Generalized Anxiety Disorder Assessment (GAD7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Scores range from 0 to 21, with higher scores indicating greater anxiety. This outcome will compare the mean change in GAD-7 scores from baseline between participants receiving one-on-one therapy and those receiving app-based therapy.
Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score
时间窗: 3 months following initiation of Healing Circuits™
Improvement is defined as a ≥2-point reduction from baseline in GAD-7 score. The outcome will compare the time (months ) it takes participants in the one-on-one therapy group and the app-based therapy group to reach this level of improvement.
Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: 3 months following initiation of Healing Circuits™
Improvement is defined as a ≥2-point reduction from baseline in PHQ-9 score. This outcome compares the time (months ) it takes for participants in the one-on-one therapy group and the app-based therapy group to reach the improvement threshold.
次要结局
- Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups(3, 6, 9, and 12 months following initiation of Healing Circuits™)
- Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score(6, 9, and 12 months following initiation of Healing Circuits™)
- Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score(This outcome measures the proportion of participants who experience a reduction of at least 2 points in the PHQ-9 (range: 0-27, higher scores = worse depression) at 6, 9, and 12 months after beginning the Healing Circuits™ intervention.)
- Mean Change in 36-Item Short Form Survey (SF-36) Score Between Groups(3, 6, 9, and 12 months following initiation of Healing Circuits™)