NCT05356130|CompletedResultsDMC
Bright Start Study
Feasibility Pilot in Preparation for Large Pragmatic Encouragement Trial of Bright Light Therapy (BLT) for Depression
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
92
1 country
1
Study Start
February 17, 2022
Actual (reported)Primary Completion
August 20, 2023
Actual (reported)Study Completion
February 21, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 21, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 17, 2022
Actual (reported)April 20, 2022
Actual (reported)May 2, 2022
Actual (reported)August 20, 2023
Actual (reported)February 21, 2024
Actual (reported)June 6, 2025
Actual (reported)Patient Health Questionnaire-9 (PHQ-9)
Change on continuous total score of the PHQ-9, a measure of self-reported depression symptoms. Minimum score = 0, maximum score = 27, higher scores = worse outcome.
Baseline through follow-up at 2, 4 and 6 months post-enrollment
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
Baseline through follow-up at 2, 4 and 6 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
Baseline through follow-up at 2, 4 and 6 months post-enrollment
"Usual care services" control group
Two minimal written communications promoting BLT as a promising treatment and outlining steps for patients to self-initiate. Arm 2 will not include any phone coaching or adherence promotion.
2-4 brief calls to encourage BLT use, advise on purchase of a light box (LB), assist with obtaining compensation for LB purchase, educate for correct LB use, and provide motivational interviewing (MI) as needed to promote adherence. Arm 3 participants will also receive the written educational material on BLT.
Participants in both Arms 2 and 3 will receive written information about how to obtain the greatest BLT benefit, including recommended day/time usage, session duration, eye distance from light box, the length of time to continue using, and the small risk of emergent mania or BD and how to recognize this. Written best practices for ideal BLT will be provided in both Arms 2 and 3 via secure EHR message, email, and/or USPS. PDFs of best practices for BLT will also be available for download on our study website.
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, 97227, United States
The relatively small pilot sample size was planned from the beginning to be insufficient for fully powered hypothesis testing, but sufficient for protocol/procedures feasibility testing. Effect sizes should be interpreted with caution. The racial and ethnic makeup of the sample limits the generalizability of results. We intentionally enrolled either SAD or non-SAD depression, which may limit generalizability due to durable medical equipment reimbursement only available for SAD depression.
Greg Clarke, PhD
Kaiser Permanente
92 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2022
First Posted
May 2, 2022
Study Start
February 17, 2022
Actual (reported)Empower@Home: A Feasibility Pilot
BLT phone coaches will follow a four-step approach in engaging with Arm 3 participants: (a) provide encouragement to consider using BLT; (b) provide guidance regarding light box purchase and assist with obtaining compensation for purchase; (c) educate participants about ideal BLT use to obtain maximum benefit; and (d) provide ongoing brief telephonic adherence promotion and motivational interviewing (MI) where warranted to maximize persistent and appropriate BLT use.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 20, 2023
Actual (reported)Study Completion
February 21, 2024
Actual (reported)Last Updated
June 6, 2025
Results First Posted
June 6, 2025
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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