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Trial record 5 of 28 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Utah, United States ) | NIH, U.S. Fed

Stabilizing Behavioral Rhythms to Improve Mental Health (SRMH)

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ClinicalTrials.gov Identifier: NCT03152864
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 22, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Utah
Information provided by (Responsible Party):
HealthRhythms, Inc.

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.


Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxiety Symptoms Sleep Symptoms Behavioral: Full Package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Stabilizing Behavioral Rhythms to Improve Mental Health
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Full Package 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

No Intervention: Sensing Only



Primary Outcome Measures :
  1. PROMIS Depression [ Time Frame: Change at each timepoint (at 4, 8, 12, and 16 weeks) ]
    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)

  2. PROMIS Anxiety [ Time Frame: Change at each timepoint (at 4, 8, 12, and 16 weeks) ]
    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).

  3. PROMIS Sleep [ Time Frame: Change at each timepoint (at 4, 8, 12, and 16 weeks) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152864


Contacts
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Contact: Ellen Frank, PhD (412) 327-0664 ellen@healthrhythms.com
Contact: Jeremy Kendrick, PhD (801) 583-2500 jeremy.kendrick@hsc.utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Jeremy Kendrick, PhD       jeremy.kendrick@hsc.utah.edu   
Contact: Ellen Frank, PhD    4123270664    ellen@healthrhythms.com   
Sponsors and Collaborators
HealthRhythms, Inc.
National Institute of Mental Health (NIMH)
University of Utah
Investigators
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Principal Investigator: Ellen Frank, PhD HealthRhythms, Inc.

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Responsible Party: HealthRhythms, Inc.
ClinicalTrials.gov Identifier: NCT03152864     History of Changes
Other Study ID Numbers: 1R44MH113520 ( U.S. NIH Grant/Contract )
R44MH113520 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms