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NCT05356130 · ClinicalTrials.gov registry record · NA
Bright Start Study
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
NCT05356130: Completed NA study, sponsored by Kaiser Permanente.
NCT05356130 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05356130, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Written Educational Material on BLT
- BEHAVIORAL Enhanced BLT Encouragement and Adherence Promotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2022-02-17 |
| Est. Completion | 2024-02-21 |
| Phase | NA |
What the finished NCT05356130 record still lists
NCT05356130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Written Educational Material on BLT is the first listed.
NCT05356130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05356130 about?
NCT05356130 is a clinical study titled "Bright Start Study". 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...
What is the current status of trial NCT05356130?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2022-02-17. Estimated completion is 2024-02-21.
What interventions are being tested in trial NCT05356130?
The interventions under investigation include: Written Educational Material on BLT (BEHAVIORAL), Enhanced BLT Encouragement and Adherence Promotion (BEHAVIORAL).
Who is sponsoring clinical trial NCT05356130?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05356130's enrollment target sits among peer trials
92 937th of 2000 higher than 1,062 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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