Postpartum Depression (PPD)
Conditions
Keywords
Circadian rhythm, Light therapy
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.
Detailed description
This study will test a consumer health light therapy device (Re-Timer)
Interventions
DEVICELight therapy
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.
Sponsors
University of Michigan
American Academy of Sleep Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate | At approximately 5 weeks after treatment is started (post-treatment) | Number of participants who enrolled/number of participants who completed trial ( ≥70% acceptable) |
| Adherence rate (as assessed through self-report) | At approximately 5 weeks after treatment is started (post-treatment) | Percent of participants who completed ≥70% light therapy intervention sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Scale (CSS) score | 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. |
| Treatment Satisfaction Scale (TSS) score | 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. |
Countries
United States
Contacts
CONTACTKelley DuBuc
PRINCIPAL_INVESTIGATORLeslie Swanson, PhD
University of Michigan
Outcome results
None listed