Back to resultsThe Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Primary Purpose
Depression, Postpartum
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Postpartum
Eligibility Criteria
Inclusion Criteria:
- Within 6 months postpartum
- Meet DSM-V diagnostic criteria for MDD
- Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).
Exclusion Criteria:
- current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
- past history of mania/hypomania,
- chronic medical conditions associated with depression (e.g., thyroid conditions)
- ocular or retinal pathology
- history of seizures or epilepsy
- color blindness
- Lupus
- currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Light Therapy
Arm Description
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Outcomes
Primary Outcome Measures
Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks
Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02769858
Brief Title
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Official Title
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light Therapy
Arm Type
Experimental
Arm Description
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Intervention Type
Device
Intervention Name(s)
Light therapy
Other Intervention Name(s)
Re-Timer
Intervention Description
Light therapy glasses
Primary Outcome Measure Information:
Title
Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks
Description
Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression
Time Frame
After five weeks of light therapy
Title
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
Description
Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.
Time Frame
After five weeks of light therapy
Title
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
Description
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin
Time Frame
After five weeks of light therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Within 6 months postpartum
Meet DSM-V diagnostic criteria for MDD
Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).
Exclusion Criteria:
current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
past history of mania/hypomania,
chronic medical conditions associated with depression (e.g., thyroid conditions)
ocular or retinal pathology
history of seizures or epilepsy
color blindness
Lupus
currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Swanson, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29603017
Citation
Swanson LM, Burgess HJ, Zollars J, Todd Arnedt J. An open-label pilot study of a home wearable light therapy device for postpartum depression. Arch Womens Ment Health. 2018 Oct;21(5):583-586. doi: 10.1007/s00737-018-0836-z. Epub 2018 Mar 30.
Results Reference
derived
Learn more about this trial
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
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