Bright Start Study

Depression Clinical Trial

Official title:

Feasibility Pilot in Preparation for Large Pragmatic Encouragement Trial of Bright Light Therapy (BLT) for Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05356130
• Other study ID #: R34MH122550
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The most common treatments for depression are antidepressant medications (ADs) and psychotherapies such as cognitive behavioral therapy (CBT). However, these treatments yield only moderate benefits under ideal circumstances. These effects are further eroded when real world patients initiate treatments at low rates and have poor adherence or early discontinuation. This represents a depression care gap that supports the development and promotion of other interventions. One of these alternative treatments, bright light therapy (BLT), has established efficacy for seasonal affective disorder (SAD) and non-SAD depression, is relatively low cost, and has few adverse effects-but is often overlooked and has little presence in routine clinical care. This R34 pilot study is in preparation for a subsequent large, pragmatic trial to examine the effectiveness of bright light therapy (BLT) for depression when delivered to real-world patients with little "scaffolding" typical of highly controlled efficacy trials. The investigators will conduct a feasibility pilot with a sample of 90 patients selected with a new clinical diagnosis of unipolar depression or SAD and PHQ-9 score >= 10, recorded in the health plan's electronic health record (EHR). Participants will be randomized to one of three arms: - Arm 1 Treatment as Usual (TAU): A "usual care services" control group (e.g., ADs, psychotherapy; all TAU is permitted and will be recorded for all participants in all conditions); - Arm 2 TAU + Minimal BLT Encouragement: TAU plus two minimal written communications (mailed letter, secure EHR message, or email) 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; - Arm 3 TAU + Enhanced BLT Encouragement + Adherence Promotion: TAU plus 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. The primary outcome is PHQ-9 self-reported depression symptoms; the primary test of BLT effectiveness is the contrast between Arms 2+3 vs. Arm 1. This underpowered pilot study is not powered for hypothesis testing. Therefore, the investigators do not expect between-condition comparisons to yield significant differences. Nonetheless, as part of this pilot the investigators will conduct analyses similar to those that would be used in the planned, 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 conduct exploratory analyses to prepare for a future fully powered trial. The investigators will examine other secondary outcomes including anxiety, disability, and mood seasonality, and other secondary contrasts; e.g., Arm 2 vs Arm 3. The investigators will also examine moderation effects; variation of BLT effects in subgroups (e.g., those receiving vs. not receiving TAU antidepressants); and the investigators will examine mechanisms of BLT and MI intervention effects via candidate mediators including normalized circadian rhythm, improved sleep, and increased physical activity (for BLT), and readiness for change (for MI). This pilot will yield feasibility products to assist with successful conduct of a subsequent full trial: estimates of recruitment success, participant retention, and adherence with BLT protocol; refinement of the adherence promotion protocol; and an estimate (with wide confidence intervals) of BLT effectiveness.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: March 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Contraindicated diagnoses or medications (see EHR exclusion criteria above) in case these are known to patients but are not EHR-recorded (e.g., if they were diagnosed with a contraindicated condition before becoming a KP member and have not yet sought care for it)
• Contraindicated diagnoses or medications (see EHR exclusion criteria) newly reported that were not captured in the EHR
• 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)

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• 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.
• Enhanced BLT Encouragement and Adherence Promotion
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northwest Center for Health Research	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR)	Change on the QIDS-SR, a self-reported measure of depression symptoms. Minimum score = 0, maximum score = 48, where higher scores = worse outcome.	Baseline through follow-up at 2, 4 and 6 months post-enrollment
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Change on self-rated PSQI questionnaire to assess sleep quality and disturbances. Minimum score = 0, maximum score = 21, where higher scores = worse outcome.	Baseline through follow-up at 2, 4 and 6 months post-enrollment