Integrated Chronotherapy for Perinatal Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 2/2/2019 |
| Start Date: | January 2014 |
| End Date: | July 2019 |
| Contact: | Katherine M Sharkey, MD, PhD |
| Email: | ksharkey@lifespan.org |
| Phone: | 401-421-9440 |
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.
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.
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)
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