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NCT Number: NCT07721064

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

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Dyssomnias Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

Digital Insomnia Program

Behavioral

A self-guided, fully automated, interactive, and tailored internet-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). It is fully accessible as a web-based application via smartphones, computers, and tablets. Content is metered out over time through six "Cores". Each Core acts as a digital analog for the typical weekly sessions of face-to-face CBT for insomnia, following the same general structure: (1) Core objectives - what will be learned and why this information is important, (2) review of previous week's homework and sleep diary data, (3) new intervention material, (4) assignment of homework - treatment strategies for the coming week, and (5) a summary of the Core's main points. Users obtain access to a new Core based on a time- and event-based schedule (i.e., time since previous Core, completion of sleep diaries).

Digital Mental Health Program

Behavioral

A self-guided, fully automated app designed for brief, frequent check-ins to promote skill acquisition. Exercises in the app are assigned for 1 week each, and each exercise focuses on a specific mental health target (e.g., cognitive restructuring, savoring positive experiences, increasing knowledge of mental health).

Psychoeducation

Behavioral

An internet delivered program that includes modules containing general health information that is not specific to mental health or insomnia. Modules contain information on the topics such as exercise and heart health,. Content is primarily text-based and contains public domain health information; that is, content that is sourced primarily from US government health websites and is non-proprietary.

Primary outcomes

  1. Patient Health-Questionnaire-8 (PHQ-8)

    Time frame: Baseline

    8 item measure to evaluate severity of depression symptoms. Each item is evaluated on a scale from 0-3. Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.

  2. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: Post 18-weeks

    8 item measure to evaluate severity of depression symptoms. Each item is evaluated on a scale from 0-3. Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.

  3. Insomnia Severity Index (ISI)

    Time frame: Baseline

    7 item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.

  4. Insomnia Severity Index (ISI)

    Time frame: Post 18-weeks

    7 item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Philip Chow, PhD

CONTACT

[email protected]

434-924-8082

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 22, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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