NCT07766161

Brief Summary

The proposed study is an open-label trial of Re-Timer® wearable morning bright light therapy for postpartum depression. The study is focused on evaluating the feasibility, acceptability, and implementation context of morning Bright Light Treatment (mBLT) for postpartum depression.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026May 2027

Study Start

First participant enrolled

July 29, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 5, 2026

Last Update Submit

August 10, 2026

Conditions

Postpartum Depression (PPD)

Keywords

Circadian rhythmLight therapy

Outcome Measures

Primary Outcomes (2)

  • Retention rate

    Number of participants who enrolled/number of participants who completed trial ( ≥70% acceptable)

    At approximately 5 weeks after treatment is started (post-treatment)

  • Adherence rate (as assessed through self-report)

    Percent of participants who completed ≥70% light therapy intervention sessions

    At approximately 5 weeks after treatment is started (post-treatment)

Secondary Outcomes (2)

  • Client Satisfaction Scale (CSS) score

    At approximately 5 weeks after treatment is started (post-treatment)

  • Treatment Satisfaction Scale (TSS) score

    At approximately 5 weeks after treatment is started (post-treatment)

Study Arms (1)

Light therapy

EXPERIMENTAL

Participants in the arm will be approximately 30 women who are within 6 months postpartum and have an Edinburgh Postnatal Depression Scale (EPDS) score \> 10.

Device: Light therapy

Interventions

Light therapyDEVICE

Participants will use the Re-Timer daily for 5 weeks (approximately 35 days). All participants will be provided with a "light therapy window" during which they will wear the device for 60 mins.

Light therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 6 months postpartum
  • EPDS score \>10

You may not qualify if:

  • Current or past-year substance use disorder
  • Lifetime history of bipolar disorder or psychotic disorder
  • Active suicidal intent
  • Retinal pathology or history of eye surgery
  • Current use of photosensitizing medications
  • Untreated sleep-disordered breathing, untreated restless legs syndrome, or narcolepsy
  • Psychotherapy or psychotropic medications started/dose changed in past month (psychotherapy started and/or current medication at stable dose ≥ 4 weeks are permitted)
  • Medical conditions contraindicated for mBLT (e.g., epilepsy/seizures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Leslie Swanson, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelley DuBuc

CONTACT

734-764-1904dubuck@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Psychiatry

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 14, 2026

Study Start

July 29, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)