Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design

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Conditions studied: Insomnia, Depression

In brief

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.

Key facts

Study ID

NCT07721064

Run by

University of Virginia

People needed

747

Starts

2026-09-30

Expected to finish

2029-08-30

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• (1) age ≥18 years
• (2) Diagnosed with stage 0-3 breast cancer
• (3) Primary treatment for cancer (i.e., chemotherapy, immunotherapy, radiation, and surgical procedures intended to remove malignant tissue) finished between 3 months to 5 years from enrollment, with the exception of adjuvant hormonal, endocrine, and immunotherapy
• (4) elevated insomnia severity as measured by the Insomnia Severity Index (ISI) score ≥ 10, and elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10
• (5) meets DSM 5 criteria for insomnia and depression.

You may not qualify if…

• (1) Current behavioral or psychological treatment for insomnia or depression
• (2) a change in medication for insomnia or depression within the past 4 weeks
• (3) irregular sleep schedules or shift work (i.e., usual bedtimes outside 8:00 p.m.-2:00 a.m. or arising time outside 4:00 a.m.-10:00 a.m.)
• (4) mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care (as indicated from the Pitt-Optimum Suicide Management Protocol)
• (5) other self-reported untreated sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome)
• (6) no reliable internet access (e.g., home broadband, public network, personal data plan) by smartphone
• (7) cannot read and speak English
• (8) does not reside within the US.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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