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

22 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

747

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22903
        • University of Virginia
        • Contact:
        • Contact:
        • Chercheur principal:
          • Philip Chow, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Digital Insomnia Program
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).
Comportemental: Digital Mental Health Program
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).
Expérimental: 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.
Comportemental: Digital Insomnia Program
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).
Comportemental: Digital Mental Health Program
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).
Comparateur actif: 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.
Comportemental: Psychoeducation
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient Health-Questionnaire-8 (PHQ-8)
Délai: 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.
Baseline
Patient Health Questionnaire-8 (PHQ-8)
Délai: 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.
Post 18-weeks
Insomnia Severity Index (ISI)
Délai: 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.
Baseline
Insomnia Severity Index (ISI)
Délai: 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.
Post 18-weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Virginia

Collaborateurs

National Cancer Institute (NCI)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 septembre 2026

Achèvement primaire (Estimé)

1 août 2029

Achèvement de l'étude (Estimé)

30 août 2029

Dates d'inscription aux études

Première soumission

17 juillet 2026

Première soumission répondant aux critères de contrôle qualité

17 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 7466
  • R01CA295673 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

Contingent on the approval of the University of Virginia

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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