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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests online programs for sleep problems and mental health in breast cancer survivors who have both insomnia (trouble sleeping) and depression. It tests each program on its own and how to use them in sequence for people who need more support.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You were diagnosed with stage 0–3 breast cancer.
  • You finished your main cancer treatment 3 months to 5 years before joining. Some follow-up hormone treatments and immunotherapy (treatment that uses the immune system) are allowed.
  • You score 10 or higher on both the ISI sleep questionnaire and the PHQ-8 depression questionnaire.
  • You meet the DSM-5 medical guidelines for both insomnia and depression.

Who can't join

  • You are getting behavioral treatment or talk therapy for insomnia or depression.
  • Your medicine for insomnia or depression changed in the past 4 weeks.
  • You have irregular sleep times or do shift work: your usual bedtime is outside 8 p.m.–2 a.m., or your wake-up time is outside 4 a.m.–10 a.m.
  • You have a history of psychosis (trouble knowing what is real) or bipolar disorder (major mood swings) that could make the study unsafe or hard to follow, or current thoughts of suicide that need more care.
  • You have another untreated sleep disorder, such as sleep apnea (breathing that stops and starts during sleep) or restless legs syndrome (a strong urge to move your legs).
  • You do not have reliable internet access through a smartphone.
  • You cannot read and speak English.
  • You do not live in the United States.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

VA