Adults 18 to 69, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient Health Questionnaire-9 (PHQ-9)Primary· Baseline through follow-up at 2, 4 and 6 months post-enrollment
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
Group
Value
95% CI
Treatment as Usual (TAU)
12.9
± 5.3
Minimal BLT Encouragement
13.7
± 5.1
Enhanced BLT Encouragement + Adherence Promotion
13.8
± 6.0
2-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
12.2
± 5.6
Minimal BLT Encouragement
10.8
± 6.5
Enhanced BLT Encouragement + Adherence Promotion
9.3
± 5.3
4-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
10.0
± 4.8
Minimal BLT Encouragement
10.0
± 5.7
Enhanced BLT Encouragement + Adherence Promotion
9.1
± 5.2
6-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
10.4
± 6.1
Minimal BLT Encouragement
9.4
± 5.4
Enhanced BLT Encouragement + Adherence Promotion
8.3
± 6.2
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)Secondary· Baseline through follow-up at 2, 4 and 6 months post-enrollment
Change on the QIDS-SR, a self-reported measure of depression symptoms. Minimum score = 0, maximum score = 48, where higher scores = worse outcome.
Baseline
Group
Value
95% CI
Treatment as Usual (TAU)
13.2
± 5.1
Minimal BLT Encouragement
13.2
± 4.0
Enhanced BLT Encouragement + Adherence Promotion
12.2
± 4.8
2-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
11.8
± 4.0
Minimal BLT Encouragement
11.3
± 4.6
Enhanced BLT Encouragement + Adherence Promotion
9.7
± 5.3
4-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
9.7
± 5.1
Minimal BLT Encouragement
9.9
± 4.3
Enhanced BLT Encouragement + Adherence Promotion
8.9
± 4.1
6-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
10.0
± 4.8
Minimal BLT Encouragement
10.0
± 4.5
Enhanced BLT Encouragement + Adherence Promotion
8.8
± 5.6
Pittsburgh Sleep Quality Index (PSQI)Secondary· Baseline through follow-up at 2, 4 and 6 months post-enrollment
Change on self-rated PSQI questionnaire to assess sleep quality and disturbances. Minimum score = 0, maximum score = 21, where higher scores = worse outcome.
Baseline
Group
Value
95% CI
Treatment as Usual (TAU)
9.6
± 3.4
Minimal BLT Encouragement
9.0
± 3.5
Enhanced BLT Encouragement + Adherence Promotion
9.1
± 3.8
2-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
10.1
± 3.8
Minimal BLT Encouragement
8.0
± 3.1
Enhanced BLT Encouragement + Adherence Promotion
8.0
± 3.4
4-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
9.4
± 4.2
Minimal BLT Encouragement
7.5
± 3.3
Enhanced BLT Encouragement + Adherence Promotion
7.1
± 2.8
6-Month Follow-up
Group
Value
95% CI
Treatment as Usual (TAU)
9.3
± 4.0
Minimal BLT Encouragement
7.2
± 2.8
Enhanced BLT Encouragement + Adherence Promotion
7.1
± 3.5
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Kaiser Permanente
Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05356130.