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Integrated Chronotherapy for Perinatal Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Rhode Island Hospital
Sponsor:
Collaborators:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Katherine M. Sharkey, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT02053649
First received: January 30, 2014
Last updated: October 26, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Depression
Major Depressive Disorder
Postpartum Depression
Behavioral: Triple Chronotherapy
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Chronotherapy for Perinatal Depression

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Change in Depression Score [ Time Frame: Change in depression score from 28 weeks of pregnancy to 6 weeks postpartum ] [ Designated as safety issue: Yes ]
    17-item Hamilton Depression score


Secondary Outcome Measures:
  • Sleep/Circadian Behavior [ Time Frame: Change in Sleep/Circadian Rhythms from 28 weeks pregnancy to 6 weeks postpartum ] [ Designated as safety issue: No ]
    sleep will be measured with wrist actigraphy and circadian phase will be measured with melatonin onset


Other Outcome Measures:
  • Side Effects [ Time Frame: Pregnancy weeks 33, 36; postpartum weeks 2, 6, 26 ] [ Designated as safety issue: Yes ]
    Systematic Assessment for Treatment Emergent Effects


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Triple Chronotherapy
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02053649

Contacts
Contact: Katherine M Sharkey, MD, PhD 401-421-9440 ksharkey@lifespan.org

Locations
United States, Rhode Island
Miriam Hospital Women's Medicine Collaborative Recruiting
Providence, Rhode Island, United States, 02904
Sub-Investigator: Teri Pearlstein, MD         
Sponsors and Collaborators
Rhode Island Hospital
The Depressive and Bipolar Disorder Alternative Treatment Foundation
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Katherine M Sharkey, MD, PhD Rhode Island Hospital
  More Information

Responsible Party: Katherine M. Sharkey, Assistant Professor, Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02053649     History of Changes
Other Study ID Numbers: 540053-2  1R34MH104377-01A1 
Study First Received: January 30, 2014
Last Updated: October 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
depression
major depressive disorder
postpartum depression
antenatal depression
sleep
circadian
bright light

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on July 26, 2016