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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|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|
- 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)
- 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).
- 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
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
|Contact: Ellen Frank, PhD||(412) email@example.com|
|Contact: Jeremy Kendrick, PhD||(801) firstname.lastname@example.org|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Jeremy Kendrick, PhD email@example.com|
|Contact: Ellen Frank, PhD 4123270664 firstname.lastname@example.org|
|Principal Investigator:||Ellen Frank, PhD||HealthRhythms, Inc.|