MHNA-001 for Young Adults With IBS

March 13, 2023 updated by: Mahana Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303
        • Carolina Institute for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 21 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MHNA-001
Device: MHNA-001
3-month digital therapy program designed to reduce the severity of IBS symptoms
Other Names:
  • Mahana™ for IBS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in IBS Severity Scoring System from Baseline to Week 12
Time Frame: 12 Weeks
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
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject's Global Assessment of Relief at Week 12
Time Frame: 12 Weeks
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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahana Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MHNA-001-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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