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

Conditions

• Depression
• Insomnia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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 Dates

First listed

Jul 22, 2026

Start date

Sep 30, 2026

Status verified

Jul 2026

Primary completion

Aug 1, 2029

Completion

Aug 30, 2029

Study Design

Enrollment

747 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Digital Insomnia Program First
  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.
• Experimental: Digital Mental Health Program First
  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.
• Active Comparator: Psychoeducation Only
  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.

Primary Outcome Measure

Patient Health-Questionnaire-8 [ Time Frame: Baseline ]

Central Contacts

• Philip Chow, PhD
  434-924-8082
  [email protected]

Locations (1)

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