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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02769858
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Depression, Postpartum	Device: Light therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks [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

2. Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks [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.

3. Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

• Lupus

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leslie Swanson, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02769858
• Other Study ID Numbers: G016030
• First Posted: May 12, 2016
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Light Therapy
Arm/Group Description	Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses
Period Title: Overall Study
STARTED	10
COMPLETED	8
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Light Therapy
Arm/Group Description	Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (3)
Sex: Female, Male (Count of Participants)
Female	10 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 20%
White	8 80%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Therapy
Arm/Group Description	Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses
Measure Participants	8
Pre-treatment	24.75 (4.83)
Post-treatment	12.88 (7.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Light Therapy
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Therapy
Arm/Group Description	Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses
Measure Participants	8
Pre-Treatment (EPDS	12.75 (4.2)
Post-Treatment (EPDS)	7.75 (7.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Light Therapy
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.019
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Therapy
Arm/Group Description	Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses
Measure Participants	8
Mean (Standard Deviation) [minutes]	-6 (20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Light Therapy
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.502
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	5 weeks
Arm/Group Title	Light Therapy
Arm/Group Description	Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses
All Cause Mortality
	Light Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Light Therapy
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Light Therapy
	Affected / at Risk (%)	# Events
Total	5/10 (50%)
Eye disorders
Eyestrain	2/10 (20%)
Nervous system disorders
Headache	5/10 (50%)
Psychiatric disorders
Irritability	4/10 (40%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.