Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT05745103
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2023-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Behavioral Healthcare Delivery Through Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline', 'description': 'The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '1 month', 'description': 'The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '2 months', 'description': 'The PHQ-9 is intended as a tool to assist clinicians with identifying and diagnosing depression.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline', 'description': 'The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '1 month', 'description': 'The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '2 months', 'description': 'The GAD-7 is intended as a tool to assist clinicians with identifying and diagnosing anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mood Disorders', 'Anxiety Disorders', 'Evidence-Based Practices', 'Community-Based Clinics', 'Artificial Intelligence'], 'conditions': ['Mood Disorders', 'Anxiety Disorders']}, 'referencesModule': {'references': [{'pmid': '37184927', 'type': 'BACKGROUND', 'citation': 'Peretz G, Taylor CB, Ruzek JI, Jefroykin S, Sadeh-Sharvit S. Machine Learning Model to Predict Assignment of Therapy Homework in Behavioral Treatments: Algorithm Development and Validation. JMIR Form Res. 2023 May 15;7:e45156. doi: 10.2196/45156.'}, {'pmid': '36147984', 'type': 'BACKGROUND', 'citation': 'Kellogg KC, Sadeh-Sharvit S. Pragmatic AI-augmentation in mental healthcare: Key technologies, potential benefits, and real-world challenges and solutions for frontline clinicians. Front Psychiatry. 2022 Sep 6;13:990370. doi: 10.3389/fpsyt.2022.990370. eCollection 2022.'}, {'pmid': '35972782', 'type': 'BACKGROUND', 'citation': 'Sadeh-Sharvit S, Rego SA, Jefroykin S, Peretz G, Kupershmidt T. A Comparison Between Clinical Guidelines and Real-World Treatment Data in Examining the Use of Session Summaries: Retrospective Study. JMIR Form Res. 2022 Aug 16;6(8):e39846. doi: 10.2196/39846.'}, {'pmid': '37428547', 'type': 'RESULT', 'citation': 'Sadeh-Sharvit S, Camp TD, Horton SE, Hefner JD, Berry JM, Grossman E, Hollon SD. Effects of an Artificial Intelligence Platform for Behavioral Interventions on Depression and Anxiety Symptoms: Randomized Clinical Trial. J Med Internet Res. 2023 Jul 10;25:e46781. doi: 10.2196/46781.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled clinical trial is to determine the feasibility, acceptability, and preliminary efficacy of an artificial intelligence platform )שׁ( for behavioral health in facilitating better clinical outcomes for adult patients receiving outpatient therapy.\n\nThe main question\\[s\\] it aims to answer are:\n\n* whether an AI platform designed for behavioral healthcare would be feasible and acceptable to patients and therapists.\n* whether the depression and anxiety outcomes of adults receiving outpatient cognitive-behavioral therapy (CBT) in a community-based clinic would be superior among patients whose therapists used an AI-based platform to support clinical decision making and administrative tasks compared to patients receiving treatment-as-usual (TAU).\n\nParticipants will receive CBT for depression or anxiety and complete standardized assessments. Participants will be followed for the first two months of therapy.', 'detailedDescription': "The need for scalable delivery of mental health care services that are efficient and effective is now a major public health priority. Artificial intelligence (AI) tools have the potential to improve behavioral healthcare services by helping clinicians collect objective data on patients' progress, streamline their workflow, and automate administrative tasks.\n\nThe goal of this study is to determine the feasibility, acceptability, and preliminary efficacy of an AI platform for behavioral health in facilitating better clinical outcomes for patients receiving outpatient therapy.\n\nThis open randomized clinical trial will compare an AI platform provided by Eleos Health to treatment-as-usual (TAU) during the first 2 months of therapy. The study will be conducted at a community-based clinic in the U.S. Participants will be adults referred for outpatient, individual cognitive behavioral therapy for a main diagnosis of a depressive or anxiety disorder. Patients will be randomized to receive either therapy provided with the support of an AI platform developed by Eleos Health or TAU at the same clinic.\n\nData analysis will be carried out based on intention-to-treat principle. The primary outcomes include the feasibility and acceptability of the AI platform. Secondary outcomes include changes in depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores as well as treatment attendance and satisfaction.\n\nFindings of this study will inform the optimization of future trials and services offered to individuals seeking mental health support in the U.S."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Older than 18 years old.\n2. Presenting for an outpatient CBT for a depressive or anxiety disorder.\n\nExclusion Criteria:\n\n1. Age \\<18.\n2. individuals who are medically unstable for outpatient treatment.\n3. a severe mental health condition that might interfere with treatment compliance (e.g., psychotic depression, psychosis, active substance dependence).'}, 'identificationModule': {'nctId': 'NCT05745103', 'briefTitle': 'Optimizing Behavioral Healthcare Delivery Through Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eleos Health'}, 'officialTitle': 'Optimizing Behavioral Healthcare Delivery Through Technology', 'orgStudyIdInfo': {'id': 'O1Z2A3R4K5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Eleos Health Platform', 'description': "Therapists in the AI group will use the HIPAA-compliant, secure, password-protected Eleos Health platform. This AI tool was designed for behavioral health to support clinical decision-making and automation of administrative tasks. The platform captures the therapist and patient's utterances during a treatment session, analyzes the data, and offers feedback on the implementation of EBPs. The platform also incorporates a measurement-based care component, wherein standardized assessment scales completed by clients are immediately summarized and graphed for the therapist, who can use these data to inform therapy and share them with the patient. Insights and key indicators from the session data and MBC are summarized into a progress note draft which the therapist can then submit or edit as needed.", 'interventionNames': ['Behavioral: Cognitive behavioral therapy with AI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as Usual', 'description': 'Participants randomized to the control group will receive the routine services provided in the center. Therapists providing TAU will be permitted to use the strategies they deen would be most successful.', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}], 'interventions': [{'name': 'Cognitive behavioral therapy with AI', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders. The Eleos Health platform provides real-time data that optimizes this therapy and helps the provider tailor the intervention to the specific client.', 'armGroupLabels': ['The Eleos Health Platform']}, {'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral therapy is a psycho-social intervention that aims to reduce symptoms of various mental health conditions, primarily depression and anxiety disorders.', 'armGroupLabels': ['Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64804', 'city': 'Joplin', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Ozark Center', 'geoPoint': {'lat': 37.08423, 'lon': -94.51328}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eleos Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Missouri Department of Mental Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}