Bright Start Study

Part of paid clinical trials in Portland, Oregon.

Sponsor
Kaiser Permanente
Study ID
NCT05356130
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Feb 17, 2022
Status verified
Sep 2024
Primary completion
Aug 20, 2023
Completion
Feb 21, 2024

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Treatment as Usual (TAU)
    "Usual care services" control group
  • Active Comparator: Minimal BLT Encouragement
    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.
  • Active Comparator: Enhanced BLT Encouragement + 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.

Primary Outcome Measure

Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline through follow-up at 2, 4 and 6 months post-enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northwest Center for Health ResearchPortlandOregon97227-

Find similar trials in Portland, OR

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Kaiser Permanente Northwest Center for Health Research· Portland, OR

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