Back to search results

Digital Programs for Insomnia and Depression in Breast Cancer Survivors

This study is looking at how well digital programs can help breast cancer survivors with insomnia (trouble sleeping) and depression. You might try a "Digital Insomnia Program," a "Digital Mental Health Program," or "Psychoeducation" (general health information). We want to see if these programs improve your sleep and mood, measured by questionnaires like the PHQ-8 and Insomnia Severity Index over 18 weeks. You could join if you are a woman aged 18 or older, have had stage 0-3 breast cancer, and finished your main cancer treatment (like chemotherapy or surgery) between 3 months and 5 years ago, and have significant insomnia.

Study design
This study is interventional and plans to include 747 women. The specific design details like randomization or blinding are not provided.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at the start of the study and again after 18 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07721064

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of Virginia
~747 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Digital Insomnia ProgramDigital Mental Health ProgramPsychoeducation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Health-Questionnaire-8 (PHQ-8)
Measured over Baseline
+3 more outcomes measured

Conditions

Insomnia
Depression

Explore related trials

Breast CarcinomaDepressionInsomnia

Where it's being run

1 sites across 1 states
Virginia1

Who to contact

Philip Chow, PhD
[email protected]
434-924-8082
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

(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

(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.

What this trial measures

  • 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.