Informing Implementation of a Circadian-Focused Intervention for Postpartum Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≤ 6 months postpartum

EPDS score >10

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Light therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retention rate

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

Time frame
At approximately 5 weeks after treatment is started (post-treatment)
2

Adherence rate (as assessed through self-report)

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

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

Secondary outcomes

1

Client Satisfaction Scale (CSS) score

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

Time frame
At approximately 5 weeks after treatment is started (post-treatment)
2

Treatment Satisfaction Scale (TSS) score

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

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

Other outcomes

Sponsors and contacts

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University of Michigan

Lead sponsor

American Academy of Sleep Medicine

Collaborator