NCT03152864

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

April 24, 2017

Last Update Submit

June 28, 2021

Conditions

Depressive SymptomsAnxiety SymptomsSleep Symptoms

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Full Package

EXPERIMENTAL
Behavioral: Full Package

Sensing Only

NO INTERVENTION

Interventions

Full PackageBEHAVIORAL

Individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) program on their smartphones

Full Package

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

  • Wallace ML, Frank E, McClung CA, Cote SE, Kendrick J, Payne S, Frost-Pineda K, Leach J, Matthews MJ, Choudhury T, Kupfer DJ. A translationally informed approach to vital signs for psychiatry: a preliminary proof of concept. NPP Digit Psychiatry Neurosci. 2024;2:14. doi: 10.1038/s44277-024-00015-8. Epub 2024 Aug 26.

    PMID: 39639945DERIVED

  • Frank E, Wallace ML, Matthews MJ, Kendrick J, Leach J, Moore T, Aranovich G, Choudhury T, Shah NR, Framroze Z, Posey G, Burgess SA, Kupfer DJ. Personalized digital intervention for depression based on social rhythm principles adds significantly to outpatient treatment. Front Digit Health. 2022 Sep 2;4:870522. doi: 10.3389/fdgth.2022.870522. eCollection 2022.

    PMID: 36120713DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Ellen Frank, PhD

    HealthRhythms, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 15, 2017

Study Start

March 1, 2018

Primary Completion

May 31, 2019

Study Completion

July 31, 2020

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

The project will contain two distinct datasets: 1) data from HealthRhythms' collaboration with ImagineCare; and 2) data from the RCT of the Rhythm Stabilization Product (n=128). The investigators will not share the first dataset because it contains proprietary data not owned by HealthRhythms. The investigators will share the RCT data which will consist of self-reported measures, smartphone-sensed data and clinical assessments. Although the final dataset will be stripped of identifiers prior to sharing, there will remain a remote possibility of deductive disclosure of participants' identity using the sensed location data. The investigators will make the data and its documentation available to individuals via a data sharing agreement that requires a prior written commitment: 1) to only use the data for research purposes and not to identify participants; 2) to protect and secure the data using best practice security methods; and 3) to destroy the data once analysis has been completed.

Locations

US(1)