Digital Behavioral Interventions for Insomnia and Depression in Breast Cancer Survivors

PC
Overseen ByPhilip Chow, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Co-occurring symptoms of insomnia and depression is very common in breast cancer survivors, and it is critical that scalable and easily accessible digital behavioral interventions are made available. Digital health interventions are scalable and accessible. Moreover, behavioral digital interventions have been shown to be effective in reducing symptoms of insomnia and depression, respectively, in breast cancer survivors, suggesting strong potential for public impact, though their potential for addressing co-occurring symptoms of insomnia/depression has not been tested. The purpose of this study is to evaluate the efficacy of a digital insomnia program and a digital mental health program in multiple ways: 1) as standalone interventions to reduce both symptoms of co-occurring insomnia and depression for breast cancer survivors; and 2) as components in adaptive behavioral treatment strategies that optimally sequence them for survivors who need additional support, resulting in a multifaceted supportive approach that is low cost, easily accessible, and highly efficient.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with both insomnia and depression.
I have been diagnosed with stage 0-3 breast cancer.
Elevated insomnia severity with Insomnia Severity Index (ISI) score ≥ 10 and elevated depression symptoms with Patient Health Questionnaire-8 (PHQ-8) score ≥ 10
See 2 more

Exclusion Criteria

Cannot read and speak English
Current behavioral or psychological treatment for insomnia or depression
I have changed my insomnia or depression medication in the last 4 weeks.
See 5 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Digital Mental Health Program FirstExperimental Treatment2 Interventions
Group II: Digital Insomnia Program FirstExperimental Treatment2 Interventions
Group III: Psychoeducation OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+