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

NCT07721064 — Not applicable, Not yet recruiting, 747 participants, University of Virginia

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Registry	NCT07721064
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, factorial, masking: single, treatment
Enrollment	747 (Estimated)
Sponsor	University of Virginia (Other); collaborators: National Cancer Institute (NCI)
Conditions	Insomnia, Depression
Interventions	Digital Insomnia Program, Digital Mental Health Program, Psychoeducation (Behavioral)
Dates	start 2026-09-30 (estimated), primary completion 2029-08-01 (estimated), completion 2029-08-30 (estimated), first posted 2026-07-22, last updated 2026-07-24
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Digital Insomnia Program First	Experimental	Behavioral: Digital Insomnia Program; Behavioral: Digital Mental Health Program	Participants assigned to receive the digital insomnia program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital mental health program) or not.
Digital Mental Health Program First	Experimental	Behavioral: Digital Insomnia Program; Behavioral: Digital Mental Health Program	Participants assigned to receive the digital mental health program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital insomnia program) or not.
Psychoeducation Only	Active comparator	Behavioral: Psychoeducation	Participants assigned to this arm will only receive the psychoeducation program for 9 weeks. They will not be eligible to be re-randomized to receive additional program.

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.

+Outcome measures

Primary outcomes

Patient Health-Questionnaire-8 (PHQ-8) [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.
Patient Health Questionnaire-8 (PHQ-8) [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.
Insomnia Severity Index (ISI) [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.
Insomnia Severity Index (ISI) [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.

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University of Virginia	Charlottesville, Virginia	United States

+Funding

NIH grants: R01CA295673