Stabilizing Behavioral Rhythms to Improve Mental Health
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/24/2019 |
| Start Date: | March 1, 2018 |
| End Date: | July 31, 2019 |
| Contact: | Ellen Frank, PhD |
| Email: | ellen@healthrhythms.com |
| Phone: | (412) 327-0664 |
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.
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.
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.
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