NCT05333926

MHNA-001 for Young Adults With IBS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Mahana Therapeutics · Industry
• Sex: All
• Age: 18 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	MHNA-001	3-month digital therapy program designed to reduce the severity of IBS symptoms

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2022-04-19
• Last updated: 2023-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study