Minimal BLT Encouragement for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Northwest Center for Health Research, Portland, OR
Depression
Written Educational Material on BLT - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline through follow-up at 2, 4 and 6 months post-enrollment

Month 6
Patient Health Questionnaire-9 (PHQ-9)
Pittsburgh Sleep Quality Index (PSQI)
Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR)

Trial Safety

Trial Design

3 Treatment Groups

Minimal BLT Encouragement
1 of 3
Treatment as Usual (TAU)
1 of 3
Enhanced BLT Encouragement + Adherence Promotion
1 of 3
Active Control

90 Total Participants · 3 Treatment Groups

Primary Treatment: Minimal BLT Encouragement · No Placebo Group · N/A

Minimal BLT Encouragement
Behavioral
ActiveComparator Group · 1 Intervention: Written Educational Material on BLT · Intervention Types: Behavioral
Treatment as Usual (TAU)NoIntervention Group · 1 Intervention: Treatment as Usual (TAU) · Intervention Types:
Enhanced BLT Encouragement + Adherence PromotionActiveComparator Group · 2 Interventions: Written Educational Material on BLT, Enhanced BLT Encouragement and Adherence Promotion · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through follow-up at 2, 4 and 6 months post-enrollment
Closest Location: Kaiser Permanente Northwest Center for Health Research · Portland, OR
Photo of Portland 1Photo of Portland 2Photo of Portland 3
2021First Recorded Clinical Trial
2 TrialsResearching Depression
1 CompletedClinical Trials

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
496 Previous Clinical Trials
22,186,097 Total Patients Enrolled
31 Trials studying Depression
127,519 Patients Enrolled for Depression
Greg Clarke, PhDPrincipal InvestigatorKaiser Permanente
1 Previous Clinical Trials
488 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 18-69 years, inclusive.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.