Depressive SymptomsPhase 2SRMHNCT03152864
Stabilizing Behavioral Rhythms to Improve Mental Health
A Phase 2 study testing Full Package in people with Depressive Symptoms and Anxiety Symptoms, run by HealthRhythms, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms, Anxiety Symptoms, Sleep Symptoms
- What is being tested?
- Full Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depressive Symptoms, Anxiety Symptoms, Sleep Symptoms
- Being tested
- Full Package
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full PackageBehavioural
Individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) program on their smartphones
| Study group | Role | What they receive |
|---|---|---|
| Full Package | Experimental | Not described Receives: Behavioral: Full Package |
| Sensing Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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
Measured: Change at each timepoint (at 4, 8, 12, and 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Mar 2018
- Primary completion31 May 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthRhythms, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Utah
- Responsible party
- Sponsor
- Investigators
- Ellen Frank, PhD, Principal investigator, HealthRhythms, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152864
- Sponsor's protocol ID
- 1R44MH113520
- Other IDs
- R44MH113520
- Acronym
- SRMH
- Status last verified
- Jun 2021
- First submitted
- 24 Apr 2017
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39639945Frank 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.
PubMed 36120713
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilizing Behavioral Rhythms to Improve Mental Health
- ClinicalTrials.gov ID
- NCT03152864
- Acronym / sponsor ID
- SRMH / 1R44MH113520
- Conditions
- Depressive Symptoms, Anxiety Symptoms, Sleep Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- HealthRhythms, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Utah
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Package | Experimental | Behavioral: Full Package |
| Sensing Only | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full PackageIndividuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) program on their smartphones | Behavioural | Full Package |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 39639945Wallace 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.
- Derived from this study: PubMed 36120713Frank 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Frank, PhD principal investigator
HealthRhythms, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Full Package in people with Depressive Symptoms and Anxiety Symptoms, run by HealthRhythms, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Depression (time frame: Change at each timepoint (at 4, 8, 12, and 16 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.