Integrated Chronotherapy for Perinatal Depression

May 24, 2019 updated by: Katherine M. Sharkey, Rhode Island Hospital
Perinatal depression is a common and serious mood disorder that increases morbidity and mortality in new mothers and results 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 suffer from circadian rhythm disruption are at risk for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an outpatient psychiatry setting to improve treatment outcomes for patients with perinatal depression. IC 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, sleep-wake behavior, social rhythms, and arousal. We will assess the feasibility, safety, and acceptability of an IC intervention for perinatal depressin by testing the treatment in expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components and will be administered via an individualized case formulation approach tailored to each patient. After a baseline assessment, IC 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 administered by a perinatal psychiatrist and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. We will assess the safety profile of the IC intervention with evaluation of side effects/adverse events. Importantly, the study will also examine the putative mechanisms by which IC is hypothesized to work and the "dose" of IC received by patients in the IC+UC group. All participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and sleep duration and timing. 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. This pilot will allow us to refine the IC intervention for future integration into various clinical settings and establish an infrastructue for a larger (R01-scale) trial, including measuring acceptability of IC among UC clinicians and implementing web-based data collection to facilitate data sharing in the planned R01. Perinatal IC could have major public health impact due to the high prevalence of perinatal depression and its negative effects on mothers and their children. This project represents a first step toward achieving this goal, as it will provide the pilot data necessary to prepare for a larger scale intervention study focused on providing non-pharmacologic therapies and improving outcomes for women with perinatal depression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Miriam Hospital Women's Medicine Collaborative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women with a diagnosis of major depressive disorder at 24-28 weeks gestation

Exclusion Criteria:

  • active psychosis or suicidality contraindicating outpatient treatment
  • bipolar disorder
  • seizure disorder
  • self report of frequent migraines/headaches precipitated by bright light or sleep deprivation
  • preexisting eye/skin disorders contraindicating light therapy
  • use of photosensitizing medications
  • primary Axis I diagnosis other than MDD (comorbid phobia, generalized or social anxiety disorder allowed)
  • 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 within 4 weeks of enrollment
  • current employment as shift worker
  • 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) < 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 the complexity of translating the research instruments is beyond the scope of this project)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care
Usual Care will consist of medication administered by a perinatal psychiatrist and/or psychotherapy
Other: Usual Care
UC will consist of medication administered by a perinatal psychiatrist and/or psychotherapy
Experimental: Triple Chronotherapy + Usual Care
triple chronotherapy (TC) will consist of bright light therapy, sleep phase advance, and sleep deprivation/restriction
Other: Usual Care
UC will consist of medication administered by a perinatal psychiatrist and/or psychotherapy
Behavioral: Triple Chronotherapy
triple chronotherapy (TC will consist of bright light therapy, sleep phase advance, and sleep deprivation/restriction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Depression Score
Time Frame: Change in depression score from 28 weeks of pregnancy to 6 weeks postpartum
17-item Hamilton Depression score
Change in depression score from 28 weeks of pregnancy to 6 weeks postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep/Circadian Behavior
Time Frame: Change in Sleep/Circadian Rhythms from 28 weeks pregnancy to 6 weeks postpartum
sleep will be measured with wrist actigraphy and circadian phase will be measured with melatonin onset
Change in Sleep/Circadian Rhythms from 28 weeks pregnancy to 6 weeks postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Side Effects
Time Frame: Pregnancy weeks 33, 36; postpartum weeks 2, 6, 26
Systematic Assessment for Treatment Emergent Effects
Pregnancy weeks 33, 36; postpartum weeks 2, 6, 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rhode Island Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
The Depressive and Bipolar Disorder Alternative Treatment Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine M Sharkey, MD, PhD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 540053-2
  • 1R34MH104377-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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