Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
22. juli 2026 oppdatert av: Philip Chow, Ph.D., University of Virginia
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
747
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Philip Chow, PhD
- Telefonnummer: 434-924-8082
- E-post: pic2u@virginia.edu
Studiesteder
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Virginia
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Charlottesville, Virginia, Forente stater, 22903
- University of Virginia
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Ta kontakt med:
- Philip Chow, PhD
- Telefonnummer: 434-924-8082
- E-post: pic2u@virginia.edu
-
Ta kontakt med:
- E-post: pic2u@virginia.edu
-
Hovedetterforsker:
- Philip Chow, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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).
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).
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|
Eksperimentell: 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.
|
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).
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).
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Aktiv komparator: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient Health-Questionnaire-8 (PHQ-8)
Tidsramme: Baseline
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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.
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Baseline
|
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Patient Health Questionnaire-8 (PHQ-8)
Tidsramme: Post 18-weeks
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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.
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Post 18-weeks
|
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Insomnia Severity Index (ISI)
Tidsramme: Baseline
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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.
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Baseline
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Insomnia Severity Index (ISI)
Tidsramme: Post 18-weeks
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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.
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Post 18-weeks
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
1. august 2029
Studiet fullført (Antatt)
30. august 2029
Datoer for studieregistrering
Først innsendt
17. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7466
- R01CA295673 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
Contingent on the approval of the University of Virginia
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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