Bright Start Study
Completed · Not applicable
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT05356130
- Run by
- Kaiser Permanente
- People needed
- 92
- Starts
- 2022-02-17
- Expected to finish
- 2024-02-21
- Last updated by the study team
- 2025-06-06
Who can join
Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Kaiser Permanente Northwest Center for Health Research — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.