Informing Implementation of a Circadian-Focused Intervention for Postpartum Depression

University of Michigan30 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Postpartum Depression (PPD)

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≤ 6 months postpartum 2. EPDS score \>10 Exclusion Criteria: 1. Current or past-year substance use disorder 2. Lifetime history of bipolar disorder or psychotic disorder 3. Active suicidal intent 4. Retinal pathology or history of eye surgery 5. Current use of photosensitizing medications 6. Untreated sleep-disordered breathing, untreated restless legs syndrome, or narcolepsy 7. Psychotherapy or psychotropic medications started/dose changed in past month (psychotherapy started and/or current medication at stable dose ≥ 4 weeks are permitted) 8. Medical conditions contraindicated for mBLT (e.g., epilepsy/seizures)

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

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)

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

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)

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)

Central Contacts

Kelley DuBuc

CONTACT

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

Data from ClinicalTrials.gov

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