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Personalized Integrated Chronotherapy for Perinatal Depression

Primary Purpose

Depression, Postpartum Depression, Prenatal Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Integrated Chronotherapy
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- 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)

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Feinstein Institute For Medical ResearchRecruiting
  • University of North CarolinaRecruiting
  • Rhode Island HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Personalize Integrated Chronotherapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Change in Depressive Symptoms
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)

Secondary Outcome Measures

Change in Circadian Phase
Time of salivary dim light melatonin onset (DLMO)
Change in Circadian Phase
Time of salivary dim light melatonin onset (DLMO)
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Change in Sleep Timing
time of sleep onset and sleep offset measured with wrist actigraphy
Infant sleep behavior
infant sleep-wake patterns will be measured with one week of ankle actigraphy
Melatonin levels and timing of onset in breastmilk
We will examine associations between salivary melatonin levels and melatonin levels in breast milk

Full Information

First Posted
April 6, 2020
Last Updated
June 30, 2023
Sponsor
Rhode Island Hospital
Collaborators
Northwell Health, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT04364646
Brief Title
Personalized Integrated Chronotherapy for Perinatal Depression
Official Title
Personalized Integrated Chronotherapy for Perinatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
Northwell Health, University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum Depression, Prenatal Disorder, Circadian Dysregulation, Pregnancy Related, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
outcome assessments are made by a blinded investigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Personalize Integrated Chronotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Integrated Chronotherapy
Other Intervention Name(s)
Chronotherapy, Triple Chronotherapy, Bright Light Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Time Frame
change from baseline at 33 weeks of gestation
Title
Change in Depressive Symptoms
Description
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Time Frame
change from baseline at 36 weeks of gestation
Title
Change in Depressive Symptoms
Description
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Time Frame
change from baseline at 2 weeks postpartum
Title
Change in Depressive Symptoms
Description
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Time Frame
change from baseline at 6 weeks postpartum
Title
Change in Depressive Symptoms
Description
Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)
Time Frame
change from baseline at 18 weeks postpartum
Secondary Outcome Measure Information:
Title
Change in Circadian Phase
Description
Time of salivary dim light melatonin onset (DLMO)
Time Frame
change from baseline at 36 weeks pregnancy
Title
Change in Circadian Phase
Description
Time of salivary dim light melatonin onset (DLMO)
Time Frame
change from baseline at 6 weeks postpartum
Title
Change in Sleep Timing
Description
time of sleep onset and sleep offset measured with wrist actigraphy
Time Frame
change from baseline at 33 weeks of pregnancy
Title
Change in Sleep Timing
Description
time of sleep onset and sleep offset measured with wrist actigraphy
Time Frame
change from baseline at 36 weeks of pregnancy
Title
Change in Sleep Timing
Description
time of sleep onset and sleep offset measured with wrist actigraphy
Time Frame
change from baseline at 2 weeks postpartum
Title
Change in Sleep Timing
Description
time of sleep onset and sleep offset measured with wrist actigraphy
Time Frame
change from baseline at 6 weeks postpartum
Title
Change in Sleep Timing
Description
time of sleep onset and sleep offset measured with wrist actigraphy
Time Frame
change from baseline at 18 weeks postpartum
Title
Infant sleep behavior
Description
infant sleep-wake patterns will be measured with one week of ankle actigraphy
Time Frame
18 weeks postpartum
Title
Melatonin levels and timing of onset in breastmilk
Description
We will examine associations between salivary melatonin levels and melatonin levels in breast milk
Time Frame
18 weeks postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
people who can become pregnant are eligible, i.e., female sex; any gender identity can be enrolled but must be pregnant
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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) Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine M Sharkey, MD, PhD
Phone
401-793-3497
Email
katherine_sharkey@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina M Deligiannidis, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samantha Meltzer-Brody, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feinstein Institute For Medical Research
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Meltzer-Brody, MD,MPH
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine M Sharkey, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Per NIMH guidelines
IPD Sharing Time Frame
when study is concluded and data are prepared
IPD Sharing Access Criteria
with approval from PI and regulatory bodies

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Personalized Integrated Chronotherapy for Perinatal Depression

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