Bright Start Study

NCT05356130 | Completed Results DMC

• 1 other identifier: R34MH122550
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

encouragement; coaching; adherence promotion; health education

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (3)

Treatment as Usual (TAU)

NO INTERVENTION

"Usual care services" control group

Minimal BLT Encouragement

ACTIVE COMPARATOR

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.

Behavioral: Written Educational Material on BLT

Enhanced BLT Encouragement + Adherence Promotion

ACTIVE COMPARATOR

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.

Behavioral: Written Educational Material on BLT; Behavioral: Enhanced BLT Encouragement and Adherence Promotion

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 + Adherence Promotion; Minimal BLT Encouragement

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.

Enhanced BLT Encouragement + Adherence Promotion

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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)

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Depression; Health Education

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Greg Clarke, PhD
• Organization: Kaiser Permanente Center for Health Research

greg.clarke@kpchr.org

503-335-2400

Study Officials

• Greg Clarke, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: February 17, 2022
• Primary Completion: August 20, 2023
• Study Completion: February 21, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)