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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH122550 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Clarke, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northwest Center for Health Research | Portland | Oregon | 97227 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual (TAU) | "Usual care services" control group |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual (TAU) | "Usual care services" control group |
| BG001 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Even though everyone contributes to the statistical analysis, we only report means for those people with observed values. | Posted | Mean | Standard Deviation | score on a scale | Baseline through follow-up at 2, 4 and 6 months post-enrollment |
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Through study completion, an average of 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual (TAU) | "Usual care services" control group | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Clarke, PhD | Kaiser Permanente Center for Health Research | 503-335-2400 | greg.clarke@kpchr.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2023 | Feb 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2021 | Feb 25, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2022 | Feb 25, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| 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. |
|
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 |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG002 | 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. 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. |
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| 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. | Even though everyone contributes to the statistical analysis, we only report means for those people with observed values. | Posted | Mean | Standard Deviation | score on a scale | Baseline through follow-up at 2, 4 and 6 months post-enrollment |
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|
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| 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. | Even though everyone contributes to the statistical analysis, we only report means for those people with observed values. | Posted | Mean | Standard Deviation | score on a scale | Baseline through follow-up at 2, 4 and 6 months post-enrollment |
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| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. 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. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | 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. 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. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| 2-Month Follow-up |
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| 4-Month Follow-up |
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| 6-Month Follow-up |
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| 2-Month Follow-up |
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| 4-Month Follow-up |
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| 6-Month Follow-up |
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