Clinical trial NCT04133519: Efficacy and Safety of IBS Digital Behavioral Treatment
Official title: The Efficacy and Safety of IBS Digital Behavioral Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: IBS - Irritable Bowel Syndrome
IBS
Irritable Bowel
Lead sponsor: metaMe Health
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).

Detailed description: EASITx is a pivotal study comparing two self-administered behavioral treatments for irritable bowel syndrome (IBS). The active treatment in EASITx is classified as Software as a Medical Device (SaaMD).

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-70
* Confirmation of the IBS and IBS subtype diagnosis by a study site physician using Rome IV diagnostic criteria
* Possess an iPhone Operating System (iOS) Apple or Android smartphone or iOS tablet (iPad) released in 2015 or later
* Agreement to input information about their abdominal pain and bowel movements on a daily basis into Curebase software
* Agreement to have their anonymized data stored in the cloud for up to 2 years after the conclusion of the study, and to have the data used for research purposes.
* Agreement to maintain stable dosage of IBS medications during the course of treatment and not to add new IBS medication or stop current IBS medications unless directed to do so by the participants treating physician. Changes in treatment will be captured using a concomitant medication assessment.
* Average "Worst Daily Pain Severity" of \>3 on a 11-point numeric rating scale (NRS) over the full 28-day pre-treatment symptom tracking period
* Consistent submission of Pain Severity scores via the Curebase app (data submitted on 80% or more of days in the symptom tracking window)

Exclusion Criteria:

* Evidence of current structural intestinal abnormalities that better explain the participant's IBS symptoms (e.g., celiac disease, inflammatory bowel disease - Crohn's Disease and ulcerative colitis, prior abdominal surgeries such as weight loss surgery or bowel resection)
* Medication use, other illnesses or conditions that can explain their gastrointestinal symptoms e.g.,regular narcotic use or dependency, Over The Counter (OTC) stimulant laxative dependence (i.e, progressively larger doses of Senna or Bisacodyl containing compounds are needed to produce a bowel movement), history of radiation to the abdomen.
* Diagnosed and/or treated for a malignancy within the past 5 years (other than localized basal or squamous cell carcinomas of the skin)
* Current psychotherapy, hypnotherapy, or cognitive behavioral therapy (CBT) for IBS
* Inability to commit to completing all treatment sessions
* Have an unstable extraintestinal condition whose immediate or foreseeable treatment needs would realistically interfere with study demands, e.g., ability to participate in online treatment sessions or follow daily diary.
* Active psychiatric disorder (e.g., post-traumatic stress disorder, depression associated with high risk of suicidal behavior, psychotic or delusional disorders, dissociative disorders, or gross cognitive impairment)
* Subjects that report a current gastrointestinal infection or an infection within the 4 weeks prior to the evaluation that would otherwise obscure IBS symptoms. In cases of gastrointestinal infection baseline evaluation will be delayed a minimum of 4 weeks until after complete recovery.
* Current or recent use of a gut-targeted antibiotic such as Neomycin or Rifaximin during the 12 weeks prior to baseline assessment. In the case of treatment with rifaximin or neomycin, eligibility will be suspended for 12 weeks from the initial date of use.
* Any condition that an investigator feels may interfere with the conduct of the study

Primary outcomes:
measure: Abdominal Pain Intensity Responder
timeFrame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
Secondary outcomes:
measure: Abdominal Pain Intensity
timeFrame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
measure: Abdominal Pain Frequency
timeFrame: Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16)
measure: Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale)
timeFrame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
measure: Daily Stool Frequency
timeFrame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
measure: Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument
timeFrame: Baseline (Week -4) to 4-weeks post-treatment (Week 16)
measure: Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Baseline (Week -4) to 4-weeks post-treatment (Week 16)
measure: Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: 4-weeks post-treatment (Week 16)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Curebase
state: California
Study officials:
affiliation: Elevated Health
name: Lucy Pun, DO
role: PRINCIPAL_INVESTIGATOR
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