Back to resultsMHNA-001 for Young Adults With IBS
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MHNA-001
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Participant meets IBS diagnostic criteria via Rome IV questionnaire.
- Participant has IBS, based on IBS-SSS score of ≥125 at time of screening (corresponding to mild, moderate, or severe IBS).
- Participant is 18-21 years of age at the time of consent.
- Participant is able to speak, read, and understand English.
- Participant is capable and willing to complete questionnaires, track symptoms, and complete exercises associated with use of Mahana™ IBS.
- Participant has unrestricted access to an iOS (running iOS 13 or later) or Android smartphone with internet connectivity and sufficient space for Mahana™ IBS to be installed.
- If participant is taking any prescription IBS-related concomitant medications, he/she must have been on a stable dose/regimen for at least 30 days prior to the date of Screening/Enrollment and is not intended to make changes to dose or regimen during the treatment period (i.e., through Week 12 of the study).
Exclusion Criteria:
- Participant has a medical or psychiatric comorbidity that might account for GI symptoms, confound the measurement of IBS symptoms, or compromise the participant's ability to complete the study (ex. inflammatory bowel disease, chronic liver disease, substance abuse disorder, etc.) in the opinion of the investigator.
- Participant is currently using opioids or plans to use for chronic pain management and/or recreation.
- Participant has been hospitalized for psychiatric reasons within 12 months prior to screening.
- Participant is currently experiencing high depression symptom severity as indicated by a score >14 on the PHQ-8.
- Participant is currently experiencing suicidal ideation as indicated by a score of 2 or 3 on item 9 of the Beck Depression Index (BDI). *
- Participant is currently using any prescription digital therapeutic that delivers components of cognitive-behavioral therapies.
- Participant has undergone CBT, any other skills-based, or GI-specific psychological therapy (e.g. Dialectical Behavioral Therapy, Acceptance and Commitment Therapy, Behavioral Activation, Problem-solving Therapy, Gut-Directed Hypnotherapy, etc.) within 2 years of study entry.
- Participant has participated in any investigational trial within 30 days prior to Screening or plans to participate in another clinical trial during the study period.
- Participant is currently pregnant or nursing.
Sites / Locations
- Carolina Institute for Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MHNA-001
Arm Description
Outcomes
Primary Outcome Measures
Change in IBS Severity Scoring System from Baseline to Week 12
The IBS Severity Scoring System (IBS-SSS) is a validated, 5-item tool for measuring the severity of IBS symptoms in adults with IBS. The survey asks respondents to rate the severity and frequency of their abdominal pain, severity of abdominal distension, stool frequency and consistency, satisfaction with their bowel habits, and interference of IBS with life in general in the last 10 days using a 100-point visual analogue scale. Scores range from 0 to 500 with higher scores indicating more severe IBS symptoms. Mean score changes of 50 points or more over a 3-month period are predictive of a clinically significant improvement
Secondary Outcome Measures
Subject's Global Assessment of Relief at Week 12
The SGA will be completed by participants at the end of treatment (Week 12). Participants rate their relief from IBS symptoms on a scale of 1 (completely relieved) to 5 (worse). Participants scoring from 1 to 3 are considered responders and those scoring 4-5 are considered non-responders.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05333926
Brief Title
MHNA-001 for Young Adults With IBS
Official Title
A Prospective, Open-Label Study of Mahana™ IBS, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Young Adults Aged 18-21 Years Old With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahana Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ IBS together with care as usual in approximately 100 young adults with Irritable Bowel Syndrome.
Detailed Description
Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-001 (Mahana™ for IBS). Participants will use MHNA-001 for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MHNA-001
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MHNA-001
Other Intervention Name(s)
Mahana™ for IBS
Intervention Description
3-month digital therapy program designed to reduce the severity of IBS symptoms
Primary Outcome Measure Information:
Title
Change in IBS Severity Scoring System from Baseline to Week 12
Description
The IBS Severity Scoring System (IBS-SSS) is a validated, 5-item tool for measuring the severity of IBS symptoms in adults with IBS. The survey asks respondents to rate the severity and frequency of their abdominal pain, severity of abdominal distension, stool frequency and consistency, satisfaction with their bowel habits, and interference of IBS with life in general in the last 10 days using a 100-point visual analogue scale. Scores range from 0 to 500 with higher scores indicating more severe IBS symptoms. Mean score changes of 50 points or more over a 3-month period are predictive of a clinically significant improvement
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Subject's Global Assessment of Relief at Week 12
Description
The SGA will be completed by participants at the end of treatment (Week 12). Participants rate their relief from IBS symptoms on a scale of 1 (completely relieved) to 5 (worse). Participants scoring from 1 to 3 are considered responders and those scoring 4-5 are considered non-responders.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant meets IBS diagnostic criteria via Rome IV questionnaire.
Participant has IBS, based on IBS-SSS score of ≥125 at time of screening (corresponding to mild, moderate, or severe IBS).
Participant is 18-21 years of age at the time of consent.
Participant is able to speak, read, and understand English.
Participant is capable and willing to complete questionnaires, track symptoms, and complete exercises associated with use of Mahana™ IBS.
Participant has unrestricted access to an iOS (running iOS 13 or later) or Android smartphone with internet connectivity and sufficient space for Mahana™ IBS to be installed.
If participant is taking any prescription IBS-related concomitant medications, he/she must have been on a stable dose/regimen for at least 30 days prior to the date of Screening/Enrollment and is not intended to make changes to dose or regimen during the treatment period (i.e., through Week 12 of the study).
Exclusion Criteria:
Participant has a medical or psychiatric comorbidity that might account for GI symptoms, confound the measurement of IBS symptoms, or compromise the participant's ability to complete the study (ex. inflammatory bowel disease, chronic liver disease, substance abuse disorder, etc.) in the opinion of the investigator.
Participant is currently using opioids or plans to use for chronic pain management and/or recreation.
Participant has been hospitalized for psychiatric reasons within 12 months prior to screening.
Participant is currently experiencing high depression symptom severity as indicated by a score >14 on the PHQ-8.
Participant is currently experiencing suicidal ideation as indicated by a score of 2 or 3 on item 9 of the Beck Depression Index (BDI). *
Participant is currently using any prescription digital therapeutic that delivers components of cognitive-behavioral therapies.
Participant has undergone CBT, any other skills-based, or GI-specific psychological therapy (e.g. Dialectical Behavioral Therapy, Acceptance and Commitment Therapy, Behavioral Activation, Problem-solving Therapy, Gut-Directed Hypnotherapy, etc.) within 2 years of study entry.
Participant has participated in any investigational trial within 30 days prior to Screening or plans to participate in another clinical trial during the study period.
Participant is currently pregnant or nursing.
Facility Information:
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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MHNA-001 for Young Adults With IBS
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