Status:
COMPLETED
Bright Start Study
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
The Bright Start study is a randomized trial to compare three approaches, or "arms", for delivering Bright Light Therapy (BLT) to real-world patients. Arm 1 participants will receive Kaiser Permanente...
Detailed Description
The most common treatments for depression are antidepressant medications (ADs) and psychotherapies such as cognitive behavioral therapy (CBT). However, these treatments yield only moderate benefits un...
Eligibility Criteria
Inclusion
- Age 18-69 years, inclusive
- New episode of unipolar depression within the last month, defined as: New ICD-10 diagnosis of SAD or unipolar depression (i.e., major depression, minor depression, depression not otherwise specified, and/or adjustment disorder with depressed mood) AND usual care administration of the PHQ-9 depression scale in the last 30 days, with a total score of 10 or higher
- Participant must have a kp.org MyChart account, with evidence of use in the last 12 months
- Able and willing to conduct study assessments and phone coaching in English
- Phone and internet access
Exclusion
- Chronic depression: ICD-10 diagnosis of SAD or unipolar depression in the 6 months prior to case-identification
- Elevated PHQ-9 (score of 10 or higher) in the 6 months prior to case identification
- Active electronic health record (EHR) diagnoses and prescriptions representing any of the following contraindications for BLT: Conditions that might render skin or eyes more vulnerable to phototoxicity (e.g., ophthalmic disorders such as cataract, macular degeneration, glaucoma, retinitis pigmentosa; disorders affecting the retina such as retinopathy, diabetes, herpes); or photosensitive skin; or if they are taking a photosensitizing medication or herb (e.g., St. John's wort or a psoralen)
- EHR-recorded diagnoses of bipolar disorder I or II
- Participation barriers (e.g., terminal end-stage cancer, moving out of the region, no locator information)
- Contraindicated diagnoses or medications (see EHR exclusion criteria above) in case these are known to patients but are not EHR-recorded (e.g., if they were diagnosed with a contraindicated condition before becoming a KP member and have not yet sought care for it)
- Contraindicated diagnoses or medications (see EHR exclusion criteria) newly reported that were not captured in the EHR
- Emergent bipolar, manic, mixed symptoms that may not have been formally diagnosed yet (e.g., significant mood swings, excessive increases in energy, dramatically less need for sleep)
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05356130
Start Date
February 17 2022
End Date
February 21 2024
Last Update
June 6 2025
Active Locations (1)
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1
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, United States, 97227