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Efficacy and Safety of IBS Digital Behavioral Treatment (EASITx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133519
Recruitment Status : Active, not recruiting
First Posted : October 21, 2019
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
metaMe Health

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Device: Arm 1 - Active behavioral Treatment Arm Device: Arm 2 - Sham Treatment Arm with inactive behavioral treatment Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of IBS Digital Behavioral Treatment Study
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Active Comparator: Arm 1
Arm 1 is an active behavioral treatment for IBS (Software as a Medical Device - SaMD).
Device: Arm 1 - Active behavioral Treatment Arm
The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and sham treatment arms receive a behavioral treatment and since the sham treatment is inactive the subjects are blinded to active treatment.

Sham Comparator: Arm 2
Arm 2 is an inactive behavioral treatment for IBS (Software as a Medical Device - SaMD)
Device: Arm 2 - Sham Treatment Arm with inactive behavioral treatment
The sham treatment consists of an identical treatment, scheduling and reminder platform as the Active Treatment Arm, but in place of the active treatment there is an inactive sham treatment administered in an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks.




Primary Outcome Measures :
  1. Abdominal Pain Intensity Responder [ Time Frame: Baseline to 4-weeks post-treatment ]

    The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked to record their "worst abdominal pain over the past 24-hours".

    An Abdominal Pain Intensity Responder is defined as a subject who experiences a decrease in the worst abdominal pain in the past 24 hours score (measured daily on a 0-10 scale) and averaged over the 4-week post-treatment assessment period of at least 30 percent compared with baseline 4-week average



Secondary Outcome Measures :
  1. Abdominal Pain Frequency [ Time Frame: Baseline to 4-weeks post-treatment ]
    Mean change in reported abdominal pain frequency

  2. Stool Consistency [ Time Frame: Baseline to 4-weeks post-treatment ]
    Mean change in reported stool consistency by Bristol Stool Form Scale (BSFS). The BSFS is a visual aid that allows patients to classify their bowel movements into seven groups ranging from diarrhea (watery stools) to constipation with separate hard lumpy stools. The mid range bowel movements 3,4 and 5 define normal stools. The effect of treatment on the proportion of normal bowel movements will be assessed.

  3. Stool Frequency [ Time Frame: Baseline to 4-weeks post-treatment ]
    Mean change in reported stool frequency

  4. Health-related Quality of Life using the IBS Quality of Life (QOL) Instrument [ Time Frame: Baseline to 4-weeks post-treatment ]
    The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 items are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. IBS QOL scores will be compared pre and post treatment and the mean difference compared by treatment.

  5. Work Productivity and Absenteeism by the Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: Baseline to 4-weeks post-treatment ]
    Productivity and absenteeism will be evaluated using tne WPAI (General Health). Outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity (worse outcomes). WPAI scores will be compared pre and post treatment and the mean difference compared by treatment.

  6. Anxiety and Depression measured using the Patient Health Questionnaire (PHQ-4) [ Time Frame: Baseline to 4-weeks post-treatment ]
    The PHQ-4 is a four question assessment of anxiety and depression. The first two questions assess anxiety and the second two depression, allowing for individual assessment and and an overall score. Each question is scored 0-3 with a maximal score of 12 indicating severe impairment. PHQ-4 scores scores will be compared pre and post treatment and the mean difference compared by treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 iOS 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 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133519


Locations
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United States, California
Curebase
San Francisco, California, United States, 94122
Sponsors and Collaborators
metaMe Health
Investigators
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Principal Investigator: Lucy Pun, DO Elevated Health
Publications:
Lackner JM. The role of psychosocial factors in functional gastrointestinal disorders. Quigley, Hongo, Fukuda (eds): Functional and GI Motility Disorders. 2014(33):104-16.
Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res and Reg Affairs, 2010;27(2):42-51

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Responsible Party: metaMe Health
ClinicalTrials.gov Identifier: NCT04133519    
Other Study ID Numbers: MM001
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by metaMe Health:
IBS - Irritable Bowel Syndrome
IBS
Irritable Bowel
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases