[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07721064":3,"trial-entities:NCT07721064":105,"trial-summary:NCT07721064":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":58,"sex":59,"minimum_age":60,"maximum_age":16,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":79,"locations":82,"central_contacts":100,"overall_officials":102,"references":103,"see_also_links":104},"NCT07721064","7466","Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design","NOT_YET_RECRUITING","2029-08-30","2026-07","2026-07-24","2026-09-30","University of Virginia","OTHER",true,"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\u002Fdepression 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.",null,[18,19],"Insomnia","Depression",[21],"breast cancer","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},747,"ESTIMATED",[30,37,41],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","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).",[35,36],"Digital Insomnia Program First","Digital Mental Health Program First",{"type":31,"name":38,"description":39,"armGroupLabels":40},"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).",[35,36],{"type":31,"name":42,"description":43,"armGroupLabels":44},"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.",[45],"Psychoeducation Only",[47,51,54,57],{"measure":48,"description":49,"timeFrame":50},"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.","Baseline",{"measure":52,"description":49,"timeFrame":53},"Patient Health Questionnaire-8 (PHQ-8)","Post 18-weeks",{"measure":55,"description":56,"timeFrame":50},"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.",{"measure":55,"description":56,"timeFrame":53},[],"FEMALE","18 Years",false,{"inclusion":63,"exclusion":69,"raw_text":78},[64,65,66,67,68],"(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.",[70,71,72,73,74,75,76,77],"(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.","Inclusion Criteria:\n\n* (1) age ≥18 years\n* (2) Diagnosed with stage 0-3 breast cancer\n* (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\n* (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\n* (5) meets DSM 5 criteria for insomnia and depression.\n\nExclusion Criteria:\n\n* (1) Current behavioral or psychological treatment for insomnia or depression\n* (2) a change in medication for insomnia or depression within the past 4 weeks\n* (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.)\n* (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)\n* (5) other self-reported untreated sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome)\n* (6) no reliable internet access (e.g., home broadband, public network, personal data plan) by smartphone\n* (7) cannot read and speak English\n* (8) does not reside within the US.",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":12,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":97},"Charlottesville","Virginia","22903","United States",[89,94,95],{"name":90,"role":91,"phone":92,"email":93},"Philip Chow, PhD","CONTACT","434-924-8082","pic2u@virginia.edu",{"role":91,"email":93},{"name":90,"role":96},"PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},38.02931,-78.47668,[101],{"name":90,"role":91,"phone":92,"email":93},[],[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107,19,18],"Breast Carcinoma",[],{"nct_id":4,"found":14,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This study is interventional and plans to include 747 women. The specific design details like randomization or blinding are not provided.","completed","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.","Your progress will be measured at the start of the study and again after 18 weeks.",101,"Not specified in the trial record.","Not stated in the trial record.",[32,38,42],"v2"]