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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 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 92 participants.

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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.

Interventions

  • BEHAVIORAL Written Educational Material on BLT
  • BEHAVIORAL Enhanced BLT Encouragement and Adherence Promotion

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2022-02-17
Est. Completion 2024-02-21
Phase NA

Sponsor

Kaiser Permanente

294 total trials

What the Registry Record Tells You About NCT05356130

The ClinicalTrials.gov registry entry for NCT05356130 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Written Educational Material on BLT is the first listed.

NCT05356130 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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