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Clinical Trials/NCT02769858
NCT02769858CompletedNot Applicable

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

University of Michigan1 site in 1 country10 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • •currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).

Arms & Interventions

Light Therapy

Experimental

Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.

Intervention: Light therapy (Device)

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leslie Swanson

Assistant Professor

University of Michigan

Study Sites (1)

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