Stabilizing Behavioral Rhythms to Improve Mental Health

Depressive Symptoms Clinical Trial

— SRMH  

Official title:

Stabilizing Behavioral Rhythms to Improve Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152864
• Other study ID #: 1R44MH113520
• Secondary ID: R44MH113520
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: June 2021
• Source: HealthRhythms, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65

• Is currently in treatment for a mood and/or anxiety disorder, as defined by the DSM-5 (American Psychiatric Association, 2013).

• Patient participants need to be on a stable medication, however changes in dosage will be allowed during the course of this study

• Ability and willingness to give informed, written consent

Exclusion Criteria:

• Severe or poorly controlled concurrent medical disorders that may cause confounding depressive symptoms (e.g., untreated hypothyroidism or lupus) or require medication(s) that could cause depressive symptoms (e.g., high doses of beta blockers or alpha interferon)

• Meets criteria for one of the following concurrent DSM-5 psychiatric disorders: any organic or psychotic mental disorder other than bipolar disorder, current alcohol or drug dependence, primary obsessive compulsive disorder, primary eating disorder, or antisocial personality disorder

• Acute suicidal or homicidal ideation or requiring psychiatric hospitalization. Those who require inpatient treatment will be excluded (or discontinued) from the study and referred to for inpatient treatment.

• Cognitive deficits precluding use of a smartphone app and/or completion of patient-reported outcomes used at the University of Utah

• Insufficient fluency in English, provide clear verbal feedback about problems with the app, complete the study assessments, or make use of a smartphone app that involves very minimal instructions written in English.

Related Conditions & MeSH terms

• Anxiety Symptoms
• Depression
• Depressive Symptoms
• Sleep Symptoms

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
HealthRhythms, Inc.	National Institute of Mental Health (NIMH), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Depression	The PROMIS Depression instruments assess self-reported negative mood (sadness, guilt), views of self (selfcriticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose)	Change at each timepoint (at 4, 8, 12, and 16 weeks)
Primary	PROMIS Anxiety	The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).	Change at each timepoint (at 4, 8, 12, and 16 weeks)
Primary	PROMIS Sleep	The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep	Change at each timepoint (at 4, 8, 12, and 16 weeks)