A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Mean Change in TFI Score From Baseline to Week 6
研究概览
简要总结
The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.
详细描述
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-003 (Mahana™ Tinnitus). Participants will use MHNA-003 for 6 weeks, completing assessments at Baseline and Weeks 2, 4, and 6 following Baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant scores ≥ 25 on the Tinnitus Functional Index.
- •Participant has experienced symptoms of tinnitus for at least 3 months.
- •Participant is at least 18 years of age at the time of consent.
- •Participant resides in the United States.
- •Participant is able to speak, read, and understand English.
- •Participant has access to an iOS or Android smartphone with the ability to complete study tasks.
- •Participant is able to commit the time required to complete therapy modules and study assessments.
排除标准
- •Participant scores ≥2 on item 9 (suicidal thoughts) of the Beck's Depression Index (BDI).
- •Participant has been hospitalized for psychiatric reasons within 12 months of screening.
- •Participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.
结局指标
主要结局
Mean Change in TFI Score From Baseline to Week 6
时间窗: 6 weeks
The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. An improvement of 13 or more points is considered a clinically meaningful change.
Tinnitus Functional Index Responder Rate
时间窗: 6 weeks
The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. A responder is defined as a participant who experienced an improvement of 13 or more points from baseline to Week 6. The responder rate is the percentage of participants considered responders at Week 6.
次要结局
未报告次要终点