NCT03152864

Stabilizing Behavioral Rhythms to Improve Mental Health

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: HealthRhythms, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In order to assess the efficacy of the Rhythm Stabilization component of HealthRhythms' product, investigators will recruit 128 outpatients between the ages of 18 and 65, presenting to the University of Utah Department of Psychiatry outpatient clinics with a current mood and/or anxiety disorder. Sixty-four of these individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) on their smartphones, while 64 will be asked to consent to Rhythm Sensing only. Participants in both arms will receive treatment as usual (TAU) for their mood and/or anxiety disorders, as typically provided at the University of Utah clinics. The duration of the study will be 16 weeks. The primary outcome measures of the RCT will be the PROMIS Depression, the PROMIS Anxiety and the PROMIS Sleep Disturbance computerized adaptive testing (CAT) measures. The investigators hypothesize that those receiving the full package will demonstrate lower levels of depression, anxiety and sleep disturbance. In addition, investigators will explore the relationship between sensed rhythm stability and scores on patient-reported outcome measures of mood, anxiety and sleep disturbance (PROMIS). The investigators hypothesize that positive changes in the PROMIS measures will be mediated by positive changes in rhythm stability. The primary outcome analyses will be based on random regression models, while the mediation analyses will follow the approach described by Helena Kraemer and colleagues.

Conditions

• Depressive Symptoms
• Anxiety Symptoms
• Sleep Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Full Package	Individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) program on their smartphones

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-05-31
• Completion: 2020-07-31
• First posted: 2017-05-15
• Last updated: 2021-07-01

Locations

1 site across 1 country: United States