Efficacy and Safety of IBS Digital Behavioral Treatment (EASITx)
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|ClinicalTrials.gov Identifier: NCT04133519|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2019
Last Update Posted : August 7, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||378 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- 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
- Abdominal Pain Frequency [ Time Frame: Baseline to 4-weeks post-treatment ]Mean change in reported abdominal pain frequency
- 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.
- Stool Frequency [ Time Frame: Baseline to 4-weeks post-treatment ]Mean change in reported stool frequency
- 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.
- 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.
- 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.
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
|United States, California|
|San Francisco, California, United States, 94122|
|Principal Investigator:||Lucy Pun, DO||Elevated Health|