Trial Outcomes & Findings for Bright Start Study (NCT NCT05356130)
NCT ID: NCT05356130
Last Updated: 2025-06-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Baseline through follow-up at 2, 4 and 6 months post-enrollment
Results posted on
2025-06-06
Participant Flow
Participant milestones
| Measure |
Treatment as Usual (TAU)
"Usual care services" control group
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
|
Overall Study
COMPLETED
|
31
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Treatment as Usual (TAU)
"Usual care services" control group
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
Baseline Characteristics
Bright Start Study
Baseline characteristics by cohort
| Measure |
Treatment as Usual (TAU)
n=31 Participants
"Usual care services" control group
|
Minimal BLT Encouragement
n=30 Participants
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.
|
Enhanced BLT Encouragement + Adherence Promotion
n=31 Participants
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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
37.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through follow-up at 2, 4 and 6 months post-enrollmentPopulation: Even though everyone contributes to the statistical analysis, we only report means for those people with observed values.
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.
Outcome measures
| Measure |
Treatment as Usual (TAU)
n=31 Participants
"Usual care services" control group
|
Minimal BLT Encouragement
n=30 Participants
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.
|
Enhanced BLT Encouragement + Adherence Promotion
n=31 Participants
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.
|
|---|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
12.9 score on a scale
Standard Deviation 5.3
|
13.7 score on a scale
Standard Deviation 5.1
|
13.8 score on a scale
Standard Deviation 6.0
|
|
Patient Health Questionnaire-9 (PHQ-9)
2-Month Follow-up
|
12.2 score on a scale
Standard Deviation 5.6
|
10.8 score on a scale
Standard Deviation 6.5
|
9.3 score on a scale
Standard Deviation 5.3
|
|
Patient Health Questionnaire-9 (PHQ-9)
4-Month Follow-up
|
10.0 score on a scale
Standard Deviation 4.8
|
10.0 score on a scale
Standard Deviation 5.7
|
9.1 score on a scale
Standard Deviation 5.2
|
|
Patient Health Questionnaire-9 (PHQ-9)
6-Month Follow-up
|
10.4 score on a scale
Standard Deviation 6.1
|
9.4 score on a scale
Standard Deviation 5.4
|
8.3 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Baseline through follow-up at 2, 4 and 6 months post-enrollmentPopulation: Even though everyone contributes to the statistical analysis, we only report means for those people with observed values.
Change on the QIDS-SR, a self-reported measure of depression symptoms. Minimum score = 0, maximum score = 48, where higher scores = worse outcome.
Outcome measures
| Measure |
Treatment as Usual (TAU)
n=31 Participants
"Usual care services" control group
|
Minimal BLT Encouragement
n=30 Participants
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.
|
Enhanced BLT Encouragement + Adherence Promotion
n=31 Participants
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.
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
Baseline
|
13.2 score on a scale
Standard Deviation 5.1
|
13.2 score on a scale
Standard Deviation 4.0
|
12.2 score on a scale
Standard Deviation 4.8
|
|
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
2-Month Follow-up
|
11.8 score on a scale
Standard Deviation 4.0
|
11.3 score on a scale
Standard Deviation 4.6
|
9.7 score on a scale
Standard Deviation 5.3
|
|
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
4-Month Follow-up
|
9.7 score on a scale
Standard Deviation 5.1
|
9.9 score on a scale
Standard Deviation 4.3
|
8.9 score on a scale
Standard Deviation 4.1
|
|
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
6-Month Follow-up
|
10.0 score on a scale
Standard Deviation 4.8
|
10.0 score on a scale
Standard Deviation 4.5
|
8.8 score on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline through follow-up at 2, 4 and 6 months post-enrollmentPopulation: Even though everyone contributes to the statistical analysis, we only report means for those people with observed values.
Change on self-rated PSQI questionnaire to assess sleep quality and disturbances. Minimum score = 0, maximum score = 21, where higher scores = worse outcome.
Outcome measures
| Measure |
Treatment as Usual (TAU)
n=31 Participants
"Usual care services" control group
|
Minimal BLT Encouragement
n=30 Participants
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.
|
Enhanced BLT Encouragement + Adherence Promotion
n=31 Participants
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.
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
9.6 score on a scale
Standard Deviation 3.4
|
9.0 score on a scale
Standard Deviation 3.5
|
9.1 score on a scale
Standard Deviation 3.8
|
|
Pittsburgh Sleep Quality Index (PSQI)
2-Month Follow-up
|
10.1 score on a scale
Standard Deviation 3.8
|
8.0 score on a scale
Standard Deviation 3.1
|
8.0 score on a scale
Standard Deviation 3.4
|
|
Pittsburgh Sleep Quality Index (PSQI)
4-Month Follow-up
|
9.4 score on a scale
Standard Deviation 4.2
|
7.5 score on a scale
Standard Deviation 3.3
|
7.1 score on a scale
Standard Deviation 2.8
|
|
Pittsburgh Sleep Quality Index (PSQI)
6-Month Follow-up
|
9.3 score on a scale
Standard Deviation 4.0
|
7.2 score on a scale
Standard Deviation 2.8
|
7.1 score on a scale
Standard Deviation 3.5
|
Adverse Events
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minimal BLT Encouragement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced BLT Encouragement + Adherence Promotion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Greg Clarke, PhD
Kaiser Permanente Center for Health Research
Phone: 503-335-2400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place