The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression

April 20, 2021 updated by: Leslie Swanson, University of Michigan
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • 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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light Therapy
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Device: Light therapy
Light therapy glasses
Other Names:
  • Re-Timer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks
Time Frame: After five weeks of light therapy
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
After five weeks of light therapy
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
Time Frame: After five weeks of light therapy
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.
After five weeks of light therapy
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
Time Frame: After five weeks of light therapy
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
After five weeks of light therapy

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Leslie Swanson, Ph.D., University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G016030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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