N/A
Completed N=92
Bright Start Study
Source: ClinicalTrials.gov NCT05356130 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Patient Health Questionnaire-9 (PHQ-9) — 12.9; 13.7; 13.8; 12.2 score on a scale
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 (KP) treatment as usual (TAU) with no BLT assistance. Arm 2 participants will receive brief written educational material on BLT but no phone coaching. Arm 3 participants will receive written educational material and phone coaching assistance for BLT initiation and adherence. This pilot will prepare for a future, fully powered effectiveness trial and is not powered for hypothesis testing. Therefore, the investigators do not expect between-condition comparisons to yield significant differences. The investigators will conduct analyses similar to those that would be used in a subsequent fully powered trial of the same design. These pilot study analyses posit that (a) Arms 2+3 are superior to Arm 1 in PHQ-9 continuous depression response; and (b) Arm 3 is superior to Arm 2 in PHQ-9 continuous depression response. The investigators will also conduct exploratory analyses to prepare for a future fully powered trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Health Questionnaire-9 (PHQ-9) |
12.9; 13.7; 13.8; 12.2; 10.8; 9.3 | — |
| SECONDARY Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR) |
13.2; 13.2; 12.2; 11.8; 11.3; 9.7 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
9.6; 9.0; 9.1; 10.1; 8.0; 8.0 | 0.014 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT05356130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.