NCT03152864: SRMH

Stabilizing Behavioral Rhythms to Improve Mental Health

Completed Phase 2 Last updated 1 July 2021

What this trial tests

Phase 2 trial testing Full Package in Depressive Symptoms in 128 participants. Completed in 31 July 2020.

Timeline

1 March 2018

Primary endpoint
31 May 2019

31 July 2020

Quick facts

Lead sponsor	HealthRhythms, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	128
Start date	1 March 2018
Primary completion	31 May 2019
Estimated completion	31 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Full Package

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →
• Anxiety Symptoms — all drugs for Anxiety Symptoms →
• Sleep Symptoms — all drugs for Sleep Symptoms →

Sponsor

HealthRhythms, Inc.

Who can join

Adults 18 to 65, any sex, with Depressive Symptoms or Anxiety Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Personalized digital intervention for depression based on social rhythm principles adds significantly to outpatient treatment.
   Frank E, Wallace ML, Matthews MJ, Kendrick J, et al · · 2022 · cited 18× · PMID 36120713 · DOI 10.3389/fdgth.2022.870522
2. A translationally informed approach to vital signs for psychiatry: a preliminary proof of concept.
   Wallace ML, Frank E, McClung CA, Cote SE, et al · · 2024 · cited 1× · PMID 39639945 · DOI 10.1038/s44277-024-00015-8
3. Precision Digital Intervention for Depression Based on Social Rhythm Principles Adds Significantly to Outpatient Treatment
   Frank E, Wallace M, Matthews MJ, Kendrick J, et al · · 2022 · DOI 10.1101/2022.05.06.22274565