Major Depressive DisorderPhase 2RAPIDNCT06345859
Regulation of Affect and Physiology in Depression
A Phase 2 study testing Heart rate variability biofeedback in people with Major Depressive Disorder, run by University of Southern California at 1 site in United States.
Trial summary
Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 31 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-27.
- No lifetime history of any psychiatric disorder.
- No first-degree relatives with a mood disorder.
Who cannot join
- Change in psychotropic medication use within the last 30 days
- Autism spectrum disorder
- Current eating disorder
- Intellectual disability
- Substance use disorder within the past 6 months
- Contraindications for magnetic resonance imaging or electrocardiogram assessment (e.g., presence of metal in body, claustrophobia, cardiac device, pregnancy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Umiemah Farrukh, 2137404503, carlab@usc.edu
About this study
Official title: Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression
Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.
- Conditions
- Major Depressive Disorder
- Being tested
- Heart rate variability biofeedback
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedbackBehavioural
This is a Phase 2 parallel intervention design with random assignment. We will randomly assign participants to one of two biofeedback conditions. Both conditions involve completing breathing exercises at home, 30 minutes per day for 10 days, while receiving continuous feedback about parasympathetic activity from the computer.
| Study group | Role | What they receive |
|---|---|---|
| Osc+ | Experimental | Osc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations. Receives: Behavioral: Heart rate variability biofeedback |
| Osc- | Active comparator | Osc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score. Receives: Behavioral: Heart rate variability biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological regulation success
A slope representing the strength of the relationship between how much each individual's heart rate variability increases after engaging in adaptive regulation strategies (reappraisal, distraction, and/or acceptance). Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
Measured: The two 10-day ambulatory assessment periods.
Average level of heart rate variability
An intercept representing the average level of heart rate variability each person experienced. Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
Measured: The two 10-day ambulatory assessment periods.
Secondary outcomes (1)
Perceived regulation success
An intercept representing the average degree of success each person perceived in regulating their affect. Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
Measured: The two 10-day ambulatory assessment periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start22 Mar 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jonathan Stange, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345859
- Sponsor's protocol ID
- UP-23-00467
- Other IDs
- R01MH133842
- Acronym
- RAPID
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per our data sharing plan, we plan to share the de-identified final research data with the broader scientific community via the National Institute of Mental Health Data Archive. This includes fMRI data, ambulatory data, and clinical, behavioral, and self-report measures.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression
- ClinicalTrials.gov ID
- NCT06345859
- Acronym / sponsor ID
- RAPID / UP-23-00467
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Apr 2024 (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.
Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osc+ | Experimental | Behavioral: Heart rate variability biofeedbackOsc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations. |
| Osc- | Active comparator | Behavioral: Heart rate variability biofeedbackOsc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-27.
- No lifetime history of any psychiatric disorder.
- No first-degree relatives with a mood disorder.
Key exclusion criteria (6 listed)
- Change in psychotropic medication use within the last 30 days
- Autism spectrum disorder
- Current eating disorder
- Intellectual disability
- Substance use disorder within the past 6 months
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 |
|---|---|---|
| Heart rate variability biofeedbackThis is a Phase 2 parallel intervention design with random assignment. We will randomly assign participants to one of two biofeedback conditions. Both conditions involve completing breathing exercises at home, 30 minutes per day for 10 days, while receiving continuous feedback about parasympathetic activity from the computer. | Behavioural | Osc+, Osc- |
Primary outcome
Physiological regulation success
Time frame: The two 10-day ambulatory assessment periods.
A slope representing the strength of the relationship between how much each individual's heart rate variability increases after engaging in adaptive regulation strategies (reappraisal, distraction, and/or acceptance). Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
Average level of heart rate variability
Time frame: The two 10-day ambulatory assessment periods.
An intercept representing the average level of heart rate variability each person experienced. Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
1 secondary outcome
Perceived regulation success
Time frame: The two 10-day ambulatory assessment periods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Per our data sharing plan, we plan to share the de-identified final research data with the broader scientific community via the National Institute of Mental Health Data Archive. This includes fMRI data, ambulatory data, and clinical, behavioral, and self-report measures.
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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.
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 Heart rate variability biofeedback in people with Major Depressive Disorder, run by University of Southern California 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umiemah Farrukh (2137404503, carlab@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological regulation success (time frame: The two 10-day ambulatory assessment periods.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.