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NCT Number: NCT07766161

Informing Implementation of a Circadian-Focused Intervention for Postpartum Depression

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.

Recruiting

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Key information

Conditions

Postpartum Depression (PPD) Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Kelley DuBuc

CONTACT

[email protected]

734-764-1904

Leslie Swanson, PhD

PRINCIPAL_INVESTIGATOR

About this study

This study will test a consumer health light therapy device (Re-Timer)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≤ 6 months postpartum
  • EPDS score >10

Exclusion criteria

  • 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)

Treatment and study plan

Light Therapy

Device

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.

Primary outcomes

  1. Retention rate

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

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

  2. Adherence rate (as assessed through self-report)

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

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

Secondary outcomes

  1. Client Satisfaction Scale (CSS) score

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

    The Client Satisfaction Scale measures satisfaction with the treatment. Total scores range from 5-20; higher total scores indicate greater treatment satisfaction.

  2. Treatment Satisfaction Scale (TSS) score

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

    The Treatment Satisfaction Scale measures the acceptability of the treatment. Total scores range from 2 to 20 ; higher scores indicate greater treatment acceptability.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelley DuBuc

CONTACT

[email protected]

734-764-1904

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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