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A Wearable Morning Light Treatment for Postpartum Depression

Primary Purpose

Post Partum Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright Light Therapy
Dim Light Therapy
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Depression focused on measuring post partum, depression, light therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • less or equal (≤) to 24 weeks postpartum
  • meet criteria for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V)
  • not currently receiving treatment for depression (for example, prescription medications or psychotherapy).

Exclusion Criteria:

  • Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID.
  • current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy.
  • retinal pathology or history of eye surgery
  • current use of photosensitizing medications,
  • current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers)
  • medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures).

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Bright Light Therapy

Dim Light Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in score for the Structured interview guide score for the Hamilton Depression Rating Scale - Seasonal Affective Version (SIGH-SAD total score)
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 in Phase angle difference
Phase angle difference is calculated as the time interval between the time of dim light melatonin onset and the midpoint of sleep.

Secondary Outcome Measures

Edinburgh Postnatal Depression Scale (EPDS) total score
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.
Epworth Sleepiness Scale (ESS) total score
Participants complete this 8 item scale and select response from would never doze (0), to high chance of dozing (3). A score of ≥ 10 indicates excessive daytime sleepiness on the ESS.
Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction with Participation in Social Roles (SPSR) total score
This is 14 questions regarding social roles where participants select items on a 5-point Likert scale (1) to very much (5). The higher the score the more satisfaction.
Patient Reported Outcomes Measurement Information System Sleep-related impairment (SRI) total score
This is an 8 question scale regarding sleep impairment where participants select items on a 6-point Likert scale not at all (0) to very much (5). The higher the score the more impairment.
Social functioning as measured by the Postpartum Bonding Questionnaire (PBQ) total score
The PBQ is a is a 25 question self-report measure of maternal-infant bonding. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), sum score ranging from 0 to 125; high = problematic.

Full Information

First Posted
April 9, 2021
Last Updated
May 17, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04845347
Brief Title
A Wearable Morning Light Treatment for Postpartum Depression
Official Title
A Wearable Morning Light Treatment for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock). Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results. The hypotheses regarding the bright light versus the placebo dim light of the study are: morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms. morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression
Keywords
post partum, depression, light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized using the minimization method. The study team will balance assignment to group based on the following baseline characteristics: baseline Structured Interview Guide For The Hamilton Depression Rating Scale (SIGH-SAD) score, maternal age, parity, and infant age.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bright Light Therapy
Arm Type
Experimental
Arm Title
Dim Light Therapy
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Bright Light Therapy
Other Intervention Name(s)
Re-Timer
Intervention Description
Participants will be provided with active, unaltered Re-Timer glasses that will be worn in the morning daily for 60 minutes for 5 weeks on study.
Intervention Type
Device
Intervention Name(s)
Dim Light Therapy
Other Intervention Name(s)
Re-Timer- (placebo version)
Intervention Description
Participants on this arm will wear the placebo version of the Re-Timer fitted with neutral density filters. These will be worn in the morning daily for 60 minutes for 5 weeks on study.
Primary Outcome Measure Information:
Title
Change in score for the Structured interview guide score for the Hamilton Depression Rating Scale - Seasonal Affective Version (SIGH-SAD total score)
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
pre-treatment (baseline), post light therapy treatment (approximately week 5)
Title
Change in Phase angle difference
Description
Phase angle difference is calculated as the time interval between the time of dim light melatonin onset and the midpoint of sleep.
Time Frame
pre-treatment (baseline), post light therapy treatment (approximately week 5)
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS) total score
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
pre-treatment (baseline), post light therapy treatment (approximately week 5)
Title
Epworth Sleepiness Scale (ESS) total score
Description
Participants complete this 8 item scale and select response from would never doze (0), to high chance of dozing (3). A score of ≥ 10 indicates excessive daytime sleepiness on the ESS.
Time Frame
pre-treatment (baseline), post light therapy treatment (approximately week 5)
Title
Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction with Participation in Social Roles (SPSR) total score
Description
This is 14 questions regarding social roles where participants select items on a 5-point Likert scale (1) to very much (5). The higher the score the more satisfaction.
Time Frame
pre-treatment (baseline), post light therapy treatment (approximately week 5)
Title
Patient Reported Outcomes Measurement Information System Sleep-related impairment (SRI) total score
Description
This is an 8 question scale regarding sleep impairment where participants select items on a 6-point Likert scale not at all (0) to very much (5). The higher the score the more impairment.
Time Frame
up to 3 months
Title
Social functioning as measured by the Postpartum Bonding Questionnaire (PBQ) total score
Description
The PBQ is a is a 25 question self-report measure of maternal-infant bonding. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), sum score ranging from 0 to 125; high = problematic.
Time Frame
pre-treatment (baseline), post light therapy treatment (approximately week 5)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: less or equal (≤) to 26 weeks postpartum meet criteria for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V) not currently receiving treatment for depression (for example, prescription medications or psychotherapy). Exclusion Criteria: Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder if the onset is outside of the perinatal period, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID. current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy. retinal pathology or history of eye surgery current use of photosensitizing medications, current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers) medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures). nightshift work currently pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelley DuBuc
Phone
734-764-2256
Email
dubuck@umich.edu
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelley DuBuc
Phone
734-764-2256
Email
dubuck@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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A Wearable Morning Light Treatment for Postpartum Depression

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