Smartphone Stress Management Training for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 2
- 主要终点
- Change in IBS Symptom Severity
研究概览
简要总结
In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=360), the investigators will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI) reduces daily life stress and IBS symptoms at post-treatment and two-month follow-up, relative to a matched MBI program with acceptance skills training removed (training in attention monitoring skills only; Monitor Only, MO-MBI) or to an active stress management training control group (Coping Control, CC). Participants will not only provide clinician and patient assessed measures of IBS symptoms at the three time points, but they will also provide sensitive experience sampling assessments (using Ecological Momentary Assessment) of their stress and symptoms in daily life at each time point. Finally, as an exploratory aim, participants will provide stool samples at baseline and post-intervention to provide the first ever test of whether MBIs can alter the gut microbiome in IBS. We will also conduct a sub-study that will include completion of a cold-water challenge performance task to test individuals' distress tolerance.
详细描述
All assessments and patient interactions have been designed with COVID-19 uncertainties in mind: the investigators can maintain social distancing and use masks during the two in-person visits, and much of the study, including the follow-up session, is conducted remotely.
Baseline Screening and Assessment. Individuals interested in participating will complete a brief online screening survey, and final study determination will be made by the recruitment project manager. For special cases where eligibility is in doubt or uncertain, members of the investigative team will be contacted to make a final determination. Each eligible participant will come to the Health and Human Performance laboratory at CMU for a baseline assessment appointment. They will be apprised of the study aims and approach, and provide written informed consent. Eligible participants will complete a baseline survey assessment (including measures such as IBS illness severity, IBS quality of life, demographics and health measures) and learn how to complete the EMA assessments on data-enabled smartphones. The EMA smartphone assessments will consist of three types of momentary experience data over a period of seven consecutive days following the baseline appointment: (1) participants will be quasi-randomly sampled 3 times per day during waking hours to assess stress, IBS symptoms, affect, coping, and mindful acceptance; (2) participants will be asked to complete event-driven momentary assessments of distress and IBS symptoms after bowel movements; and (3) participants will be asked to complete a daily diary assessment to assess IBS symptoms, IBS distress, social interactions, and loneliness and mood throughout the day. The investigators will implement an easy-to-use smartphone-enabled EMA sampling program that is downloaded onto each of the phones provided to participants for the duration of the study. Participants will be instructed to complete each EMA assessment within the allotted 60 minute window for quasi-random daily surveys, and within the allotted 3 hour window for daily dairy assessments. Additionally, participants will be given instructions on how to provide a baseline stool sample for microbiome analysis.
Intervention. Participants will be randomized to either MA-MBI, MO-MBI, or Coping Control (CC) using a 2:2:1 randomization sequence (i.e., for every five individuals randomized, 1 will be assigned to CC). Participants will remain blind to the type of intervention program they are receiving until post-study debriefing, to minimize potential expectancies. The MA-MBI program is a Mindfulness-Based Intervention (MBI). The instructed meditation techniques enable participants to (a) monitor their present-moment body experience while (b) accepting each experience. The MO-MBI program is structurally matched to the MA-MBI program, with no instruction on acceptance. The program instructs participants to concentrate on and (a) monitor physical and emotional body experience during each meditation practice. The Coping Control (CC) program, also matched to the MBI programs, includes no monitoring or acceptance instruction and instead focuses on coping effectiveness strategies. Participants are instructed in 3 skills: (a) thoughtful reflection; (b) reappraisal and reframing past and anticipated stressful events; and (c) problem solving, such as analyzing and solving personal problems. Each intervention begins with the same 5-minute introductory video and involves the completion of one 20-minute audio-guided lesson plus daily life homework practice (3-10 minutes) each day for 14 days. Lessons train specific techniques through didactic explanation and guided practices. After each lesson, participants will complete event-based assessments of stress and IBS distress. On Days 3 and 9 of the intervention program, study staff will contact participants by phone to answer training-specific questions, address difficulties, and encourage program adherence.
Post-Treatment Assessment. Participants in all three conditions will be asked to complete a week of EMA sampling in the week following the completion of the intervention programs, identical in form to their baseline EMA week. They will then come back into the lab for a post-intervention assessment of the same measures used during the baseline assessment, as well as to provide a second stool sample.
2-Month Follow-Up Assessment. Two months after the intervention, participants will complete a final week of EMA sampling. They will then be scheduled to complete a final assessment remotely, where they will complete the same trial outcomes assessment battery as they did at baseline and post-intervention. Additionally, participants will be asked to complete a treatment program evaluation survey measure at this time. After completing the study measures at the 2-month follow-up assessment, participants will be debriefed on the study aims and thanked for their participation.
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
- Double (Participant, Investigator)
盲法说明
All study investigators and the participant (excluding the independent unblinded statistician and unblinded project manager(s)), will be blinded to condition assignment.
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
- •Rome IV IBS diagnosis
- •Indicate moderate to high levels of psychological distress over the past two weeks (composite score >=4 on the Patient Health Questionnaire-4)
- •Willingness to provide assessments of bowel symptoms and complete study measures (including smartphone assessments)
- •Willingness/availability to be randomized and participate in all study activities
排除标准
- •Non-English speaking
- •Report a new diagnosis of a (non-acute) medical or psychiatric condition requiring treatment within the last 3 months
- •Have a history of diagnosed IBD or gastrointestinal malignancies.
- •Begun any new treatments for IBS in the four weeks prior to baseline
- •Currently pregnant
- •Had a colonoscopy within 2 weeks of enrolling in the study or within the first 4 weeks of study procedures
- •CGI Interview Only: Is a patient of Dr. David Levinthal
- •Cold Challenge Sub-study. Exclusion criteria: an existing pain condition, Reynaud's disease, history of heart/cardiovascular disease, high blood pressure, recent injuries, circulatory disorders, current or past frostbite, open cuts, or sores in both hands, a history of seizures, asthma, sickle cell disease or trait, cerebrovascular disease, a recent stroke or heart attack, or anxiolytic medication (e.g., Ativan, Xanax) or pain medication (e.g., aspirin) taken in the 2 hours prior to the study, pregnant or might be pregnant, and/or have a tendency/history of fainting after vaccines, shots, and/or blood draws. Participants will be excluded if they have taken anxiolytic medication (e.g., Ativan, Xanax) or pain medication (e.g., aspirin) taken in the 2 hours prior to the lab session. Participants who report viral illness (e.g., cold) and/or negative physical health symptoms (e.g., stomachache, nausea, fever, dehydration, hunger, sleep deprivation) before the start of the session will also be excluded.
- •As they will be visiting our laboratory on campus, participants will now be required to show proof of COVID-19 vaccination to participate in the study. Participants must also show proof of a booster shot, if they do not have one, they will be asked to wear a mask at in-person sessions to participate. Moving forward, we will continue to follow CMU COVID protocols.
结局指标
主要结局
Change in IBS Symptom Severity
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), queries patients on the severity and occurrence of abdominal pain, bloating, tightness, and bowel habits, and IBS life interference over the previous ten days. Scores are totaled (0-500 range) to obtain a composite IBS severity score, with the scale demonstrating acceptable clinical sensitivity to change (50 point changes indicate clinical improvement).
IBS Symptom Improvement
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
The Clinical Global Impressions Scale (CGI-I), a one-item 7-point measure, evaluates improvement in overall clinical condition (1= very much improved since the initiation of the treatment to 7=very much worse since the initiation of the treatment).
Change in Self-Reported Symptom-Related Psychological Outcomes
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
The Brief Symptom Inventory 18-item is a self-report measure used to assess psychological problems in adults. The scale asks patients to rate how bothered they were by symptoms on a 5-point scale (1=not at all bothered to 5= extremely bothered). Therefore, total scores can range from 18 to 90, with a higher score indicating greater distress.
Change in Self-Reported IBS Quality of Life
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
The Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a 34-item scale that measures quality of life specific to IBS. The scores are transformed to a 0-100 scale, with higher scores corresponding to better IBS specific quality of life.
Change in Microbiome Biology
时间窗: Change from baseline to 1-week post-intervention
Gut microbiome diversity evaluated using shotgun metagenomic sequencing for stool samples
Change in Self-Reported Perceptions of Stress
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
Evaluated using Ecological Momentary Assessment using the items "Right now, how much stress are you experiencing or feeling?" (1=no stress to 7 = extremely severe stress); "Since the last survey, did you experience any feelings of stress?" (yes/no).
Change in Self-Reported Perceptions of IBS Distress
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
Evaluated using Ecological Momentary Assessment using the items "Right now, how severe are your IBS symptoms right now? (1=no symptoms to 7=extremely severe symptoms); "Right now, how much are your IBS symptoms interfering with your life right now?" (1=not at all to 7=extremely); "Right now, my IBS symptoms are causing me distress" (1=no distress to 7= extremely severe distress).
Change in Self-Reported Perceptions of IBS Distress During Bowel Movements
时间窗: Change from baseline to 1-week post-intervention and 2-month follow-up
Evaluated using Event-Triggered Ecological Momentary Assessment. Measures their perceptions of distress in the minutes leading up to sitting on the toilet ("how distressed did you feel in the ten minutes leading up to sitting on the toilet? 1=not at all distressed to 7= extremely distressed) and during the bowel movement attempt ("how distressed did you feel while sitting on the toilet? 1=not at all distressed to 7= extremely distressed).
Pain Tolerance following Cold Pressor Task
时间窗: Differences across all three conditions collected at post-intervention
Evaluated by length of time (in minutes, seconds, and milliseconds) participant's hand is under water, where the maximum amount of time is 5 minutes, 0 seconds, 0 milliseconds. Measures the degree of pain/discomfort that can be withstood by the participants following completion of their assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.
Sensation Intensity Rating following Cold Pressor Task
时间窗: Differences across all three conditions collected at post-intervention
Evaluated using a Likert-type scale on a single item ("how intense are the sensations for you at the moment?", 1=no sensations, 10=most intense sensations) every 30 seconds, measures the degree of intense sensations felt following completion of participant's assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.
Distress Rating following Cold Pressor Task
时间窗: Differences across all three conditions collected at post-intervention
Evaluated using a Likert-type scale on a single item ("how distressed are you by the sensations at the moment?", 1=no distress, 10=worse distress) every 30 seconds, measures the degree of distress tolerance that can be withstood by participants following completion of participant's assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.
次要结局
- Change in Gastrointestinal Symptom-Specific Anxiety(Change from baseline to 1-week post-intervention)
- Change in Self-Reported Perceived Stress(Change from baseline to 1-week post-intervention and 2-month follow-up)
- Change in Self-Reported Depressive Symptomatology(Change from baseline to 1-week post-intervention and 2-month follow-up)
- Change in Self-Reported Mindfulness(Change from baseline to 1-week post-intervention and 2-month follow-up)
- Change in Self-Reported Loneliness(Change from baseline to 1-week post-intervention and 2-month follow-up)
- Change in Self-Reported Distress Tolerance(Change from baseline to 1-week post-intervention and 2-month follow-up)
- Change in Self-Reported Perceived Partner Responsiveness(Change from baseline to 1-week post-intervention and 2-month follow-up)
- Change in Self-Reported Sensitivity and Attention to Interoceptive Signals(Change from baseline to 1-week post-intervention)
研究者
David Creswell
Associate Professor of Psychology, Principal Investigator
Carnegie Mellon University