InsomniaNCT07721064
Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
A study testing Digital Insomnia Program, Digital Mental Health Program and Psychoeducation in people with Insomnia and Depression, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Digital Insomnia Program, Digital Mental Health Program and Psychoeducation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 747 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Philip Chow, PhD, 434-924-8082, pic2u@virginia.edu
pic2u@virginia.edu
About this study
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.
- Conditions
- Insomnia, Depression
- Being tested
- Digital Insomnia Program, Digital Mental Health Program, Psychoeducation
- Keywords
- breast cancer
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Insomnia ProgramBehavioural
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 ProgramBehavioural
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).
PsychoeducationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Digital Insomnia Program First | Experimental | 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. Receives: Behavioral: Digital Insomnia Program; Behavioral: Digital Mental Health Program |
| Digital Mental Health Program First | Experimental | 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. Receives: Behavioral: Digital Insomnia Program; Behavioral: Digital Mental Health Program |
| Psychoeducation Only | Active comparator | 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. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health-Questionnaire-8 (PHQ-8)
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.
Measured: Baseline
Patient Health Questionnaire-8 (PHQ-8)
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.
Measured: Post 18-weeks
Insomnia Severity Index (ISI)
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.
Measured: Baseline
Insomnia Severity Index (ISI)
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.
Measured: Post 18-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 747 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Philip Chow, Ph.D., University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721064
- Sponsor's protocol ID
- 7466
- Other IDs
- R01CA295673
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contingent on the approval of the University of Virginia
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
- ClinicalTrials.gov ID
- NCT07721064
- Acronym / sponsor ID
- 7466
- Conditions
- Insomnia, Depression
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 747 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Digital Insomnia Program First | Experimental | Behavioral: Digital Insomnia Program, Behavioral: Digital Mental Health ProgramParticipants 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 ProgramParticipants 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: PsychoeducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (8 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Insomnia ProgramA 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). | Behavioural | Digital Insomnia Program First, Digital Mental Health Program First |
| Digital Mental Health ProgramA 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). | Behavioural | Digital Insomnia Program First, Digital Mental Health Program First |
| PsychoeducationAn 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. | Behavioural | Psychoeducation Only |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided. Contingent on the approval of the University of Virginia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Insomnia Program, Digital Mental Health Program and Psychoeducation in people with Insomnia and Depression, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Chow, PhD (434-924-8082, pic2u@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health-Questionnaire-8 (PHQ-8) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.