DepressionNCT04364646
Personalized Integrated Chronotherapy for Perinatal Depression
A study testing Personalized Integrated Chronotherapy in people with Depression and Postpartum Depression, run by Rhode Island Hospital at 3 sites in United States.
Trial summary
Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Postpartum Depression, Prenatal Disorder
- What is being tested?
- Personalized Integrated Chronotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Nov 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women, ages 18-45 years with a HAMD score >=14 and a current DSM-5 diagnosis of major depressive disorder as determined with the Current Major Depression Module of the Structured Clinical Interview for DSM disorders (SCID-I/P)
Who cannot join
- active psychosis or suicidality contraindicating outpatient treatment as determined by the clinical judgement of the research team and as measured with the B/C module of the SCID-I/P and the Columbia-Suicide Severity Rating Scale
- bipolar disorder (because sleep restriction can increase risk of conversion to mania)
- seizure disorder (because sleep restriction can increase seizure risk)
- self report of frequent migraines/headaches precipitated by bright light or sleep deprivation
- preexisting eye/skin disorders contraindicating light therapy
- use of photosensitizing medications
Show all 15Show fewer
- primary Axis I diagnosis other than MDD (e.g., anorexia nervosa, ADHD)
- high risk pregnancy (e.g., conditions requiring mandatory bed rest or complex medical regimens that will interfere with study participation or conditions where poor infant outcomes are anticipated)
- starting antidepressants in the 4 weeks prior to enrollment
- current employment as night shift worker
- Alcohol Use Disorders Identification Test (AUDIT) score > 8 and/or Drug Abuse Screening Test (DAST) > 1 indicating current alcohol or drug use disorders
- women whose infants will not be living in the home or who will have a nighttime caregiver
- Pittsburgh Sleep Quality Inventory (PSQI)190 < 5 (i.e., those who report no sleep complaints during 3rd trimester of pregnancy and for whom an intervention targeting sleep might not be indicated).
- women who do not speak and read English because PIC research instruments are only available in English at this time. If this RCT shows effectiveness, future work will examine effectiveness in women who speak and read languages other than English.
- Women who experience fetal loss or stillbirth, as well as mothers whose infants are born before 36 weeks' gestation or have NICU stays > 5 days, will be discontinued from the study but will continue to receive UC.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Feinstein Institute For Medical Research
Glen Oaks, New York, 11004
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks' gestation), at 36 weeks' gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.
Read the detailed description
The purpose of this research study is to collect data on whether adding light therapy and a prescribed sleep schedule to usual treatment for depression can reduce depression and anxiety symptoms during pregnancy and the postpartum. The study is enrolling pregnant woman between the ages of 18 and 40 who have been diagnosed with depression and (possibly) anxiety.
This study takes place from the 3rd trimester of pregnancy to 18 weeks postpartum. Women who take part in this study will be randomly assigned ("randomized") into one of the study treatment groups (1) the "usual care" group (UC); or (2) the group that receives bright light therapy and a prescribed sleep schedule, also called the "Personalized Integrated Chronotherapy" group (PIC). The usual care group will receive medications and/or talk therapy as decided by the woman and her doctor. Women in the integrated chronotherapy group will receive usual care (as above) and will also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor. Light will be delivered with a portable, broad-spectrum light box. Both groups will have their sleep and light levels monitored during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and 18 after the baby is born (postpartum weeks 2-6 and 18) Sleep monitoring takes place in the home using a small wrist activity monitor called an "actigraph." Participants will also be asked to provide three saliva sample sets over the course of the study to measure melatonin levels.
In addition to the "Personalized Integrated Chronotherapy" study treatment that will supplement the clinical care as described above, participants will be asked to come in for research study visits.
- Conditions
- Depression, Postpartum Depression, Prenatal Disorder, Circadian Dysregulation, Pregnancy Related, Sleep Disturbance
- Being tested
- Personalized Integrated Chronotherapy
- Medical subject headings
- Depression, Depression, Postpartum, Chronobiology Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Integrated ChronotherapyBehavioural
Also called Chronotherapy, Triple Chronotherapy, Bright Light Therapy
Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Women in the usual care group receive medications and/or talk therapy. Sleep and light levels are monitored at home with wrist actigraphy during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and18 after the baby is born (postpartum weeks 2-6 and 18). Receives: Behavioral: Personalized Integrated Chronotherapy |
| Personalize Integrated Chronotherapy | Experimental | Women in the integrated chronotherapy group receive usual care (medications and/or talk therapy, as above) and also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor. Receives: Behavioral: Personalized Integrated Chronotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms
Change in the Hamilton Depression Rating Scale score (range=0-54, higher scores indicate more depressive symptoms), average baseline score was ~19 in both groups, and remission goal is a score of 7 or a change of ~12.
Measured: change from baseline at 33 weeks of gestation
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Measured: change from baseline at 36 weeks of gestation
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Measured: change from baseline at 2 weeks postpartum
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Measured: change from baseline at 6 weeks postpartum
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Measured: change from baseline at 18 weeks postpartum
Secondary outcomes (9)
Change in Circadian Phase
Time of salivary dim light melatonin onset (DLMO)
Measured: change from baseline at 36 weeks pregnancy
Change in Circadian Phase
Time of salivary dim light melatonin onset (DLMO)
Measured: change from baseline at 6 weeks postpartum
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Measured: change from baseline at 33 weeks of pregnancy
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Measured: change from baseline at 36 weeks of pregnancy
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Measured: change from baseline at 2 weeks postpartum
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Measured: change from baseline at 6 weeks postpartum
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Measured: change from baseline at 18 weeks postpartum
Infant Sleep Behavior
infant sleep-wake patterns will be measured with one week of ankle actigraphy
Measured: 18 weeks postpartum
Melatonin Levels and Timing of Onset in Breastmilk
We will examine associations between salivary melatonin levels and melatonin levels in breast milk
Measured: 18 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start2 Nov 2020
- Primary completion22 Oct 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Katherine M. Sharkey, Rhode Island Hospital
- Investigators
- Kristina M Deligiannidis, MD, Principal investigator, Northwell HealthSamantha Meltzer-Brody, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364646
- Sponsor's protocol ID
- 18-0913
- Status last verified
- Nov 2025
- First submitted
- 6 Apr 2020
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIMH guidelines
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Integrated Chronotherapy for Perinatal Depression
- ClinicalTrials.gov ID
- NCT04364646
- Acronym / sponsor ID
- 18-0913
- Conditions
- Depression, Postpartum Depression, Prenatal Disorder, Circadian Dysregulation, Pregnancy Related, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Northwell Health, University of North Carolina, Chapel Hill
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks' gestation), at 36 weeks' gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.
Detailed description
The purpose of this research study is to collect data on whether adding light therapy and a prescribed sleep schedule to usual treatment for depression can reduce depression and anxiety symptoms during pregnancy and the postpartum. The study is enrolling pregnant woman between the ages of 18 and 40 who have been diagnosed with depression and (possibly) anxiety.
This study takes place from the 3rd trimester of pregnancy to 18 weeks postpartum. Women who take part in this study will be randomly assigned ("randomized") into one of the study treatment groups (1) the "usual care" group (UC); or (2) the group that receives bright light therapy and a prescribed sleep schedule, also called the "Personalized Integrated Chronotherapy" group (PIC). The usual care group will receive medications and/or talk therapy as decided by the woman and her doctor. Women in the integrated chronotherapy group will receive usual care (as above) and will also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor. Light will be delivered with a portable, broad-spectrum light box. Both groups will have their sleep and light levels monitored during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and 18 after the baby is born (postpartum weeks 2-6 and 18) Sleep monitoring takes place in the home using a small wrist activity monitor called an "actigraph." Participants will also be asked to provide three saliva sample sets over the course of the study to measure melatonin levels.
In addition to the "Personalized Integrated Chronotherapy" study treatment that will supplement the clinical care as described above, participants will be asked to come in for research study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Personalized Integrated ChronotherapyWomen in the usual care group receive medications and/or talk therapy. Sleep and light levels are monitored at home with wrist actigraphy during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and18 after the baby is born (postpartum weeks 2-6 and 18). |
| Personalize Integrated Chronotherapy | Experimental | Behavioral: Personalized Integrated ChronotherapyWomen in the integrated chronotherapy group receive usual care (medications and/or talk therapy, as above) and also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women, ages 18-45 years with a HAMD score >=14 and a current DSM-5 diagnosis of major depressive disorder as determined with the Current Major Depression Module of the Structured Clinical Interview for DSM disorders (SCID-I/P)
Key exclusion criteria (15 listed)
- active psychosis or suicidality contraindicating outpatient treatment as determined by the clinical judgement of the research team and as measured with the B/C module of the SCID-I/P and the Columbia-Suicide Severity Rating Scale
- bipolar disorder (because sleep restriction can increase risk of conversion to mania)
- seizure disorder (because sleep restriction can increase seizure risk)
- self report of frequent migraines/headaches precipitated by bright light or sleep deprivation
- preexisting eye/skin disorders contraindicating light therapy
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 |
|---|---|---|
| Personalized Integrated ChronotherapyAlso: Chronotherapy, Triple Chronotherapy, Bright Light TherapyBased on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light. | Behavioural | Personalize Integrated Chronotherapy, Usual Care |
Primary outcome
Change in Depressive Symptoms
Time frame: change from baseline at 33 weeks of gestation
Change in the Hamilton Depression Rating Scale score (range=0-54, higher scores indicate more depressive symptoms), average baseline score was ~19 in both groups, and remission goal is a score of 7 or a change of ~12.
Change in Depressive Symptoms
Time frame: change from baseline at 36 weeks of gestation
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Time frame: change from baseline at 2 weeks postpartum
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Time frame: change from baseline at 6 weeks postpartum
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Time frame: change from baseline at 18 weeks postpartum
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
9 secondary outcomes
Change in Circadian Phase
Time frame: change from baseline at 36 weeks pregnancy
Change in Circadian Phase
Time frame: change from baseline at 6 weeks postpartum
Change in Sleep Timing
Time frame: change from baseline at 33 weeks of pregnancy
Change in Sleep Timing
Time frame: change from baseline at 36 weeks of pregnancy
Change in Sleep Timing
Time frame: change from baseline at 2 weeks postpartum
Change in Sleep Timing
Time frame: change from baseline at 6 weeks postpartum
Change in Sleep Timing
Time frame: change from baseline at 18 weeks postpartum
Infant Sleep Behavior
Time frame: 18 weeks postpartum
Melatonin Levels and Timing of Onset in Breastmilk
Time frame: 18 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Per NIMH guidelines
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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.
Kristina M Deligiannidis, MD principal investigator
Northwell Health
Samantha Meltzer-Brody, MD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Integrated Chronotherapy in people with Depression and Postpartum Depression, run by Rhode Island Hospital at 3 sites 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 1 inclusion and 15 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Depressive Symptoms (time frame: change from baseline at 33 weeks of gestation). The study lists 5 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 9 Dec 2025.