Clinical trial NCT03152864: Stabilizing Behavioral Rhythms to Improve Mental Health
Official title: Stabilizing Behavioral Rhythms to Improve Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Symptoms
Anxiety Symptoms
Sleep Symptoms
Lead sponsor: HealthRhythms, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Utah
First posted: 2017-05-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: PROMIS Depression
timeFrame: Change at each timepoint (at 4, 8, 12, and 16 weeks)
measure: PROMIS Anxiety
timeFrame: Change at each timepoint (at 4, 8, 12, and 16 weeks)
measure: PROMIS Sleep
timeFrame: Change at each timepoint (at 4, 8, 12, and 16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: HealthRhythms, Inc.
name: Ellen Frank, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.