Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04839718
Status:
WITHDRAWN
Last Update Posted:
2023-03-02
First Post:
2021-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study redesigned to be a data-only cohort study and not a clinical trial prior to any patient recruitment activities.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reach', 'timeFrame': 'through study completion, 2 years', 'description': 'Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT'}], 'secondaryOutcomes': [{'measure': 'Member characteristics associated with depression remission', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience).'}, {'measure': 'Member characteristics associated with anxiety remission', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience).'}, {'measure': 'Efficacy: Patient therapy engagement', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'number of therapy contacts (individual, group and combined)'}, {'measure': 'Efficacy: Patient medication provider engagement', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'number of clinical pharmacy contacts'}, {'measure': 'Efficacy: Patient medication engagement', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'medication length of treatment'}, {'measure': 'Efficacy: Patient psychiatry engagement', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'number of contact with psychiatrist'}, {'measure': 'Efficacy: Patient time to care', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'average time from ADAPT referral to first appointment with therapist or pharmacist'}, {'measure': 'Efficacy: Depression outcomes', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Examine if patients enrolled in ADAPT demonstrate non-inferior depression outcomes defined by change in the patient health questionnaire (PHQ-9) score compared to treatment as usual.'}, {'measure': 'Efficacy: Anxiety outcomes', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual.'}, {'measure': 'Efficacy: Time to clinical improvement', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Compare time to clinical improvement as defined by change in Adult Outcomes Questionnaire (AOQ score) from baseline to 3, and 6 months for members in ADAPT compared to treatment as usual.'}, {'measure': 'Implementation: measurement-based care', 'timeFrame': 'through study completion, 2 years', 'description': 'Examine provider use of measurement-based care'}, {'measure': 'Implementation: Diagnosis', 'timeFrame': 'through study completion, 2 years', 'description': 'Examine provider use of a specific depression or anxiety diagnosis'}, {'measure': 'Maintenance: Measurement-based care', 'timeFrame': 'through study completion, 2 years', 'description': 'Examine provider use of measurement-based care over time'}, {'measure': 'Maintenance: Diagnosis', 'timeFrame': 'through study completion, 2 years', 'description': 'Examine provider use of a specific depression or anxiety diagnosis over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Anxiety'], 'conditions': ['Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients. Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. ADAPT is a novel collaborative care model. By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times. This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care. The hypothesis is that: ADAPT program will have good program reach and efficacy. We will examine program implementation and maintenance. Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Outcomes Questionnaire (AOQ) score between 10-30\n* English-Speaking\n\nExclusion Criteria:\n\n* High risk for suicide defined by answer to question 9 on PHQ-9 of 1 or more\n* Diagnosis of bipolar disorder\n* Diagnosis of a psychotic disorder\n* Dementia diagnosis\n* Active substance use disorder diagnosis\n* Current hospice\n* Current home-based palliative care\n* Residing in a skilled nursing facility\n* Residing in an assisted living facility\n* Non-Kaiser Permanente Member\n* Established psychiatric care outside of Kaiser Permanente'}, 'identificationModule': {'nctId': 'NCT04839718', 'acronym': 'ADAPT', 'briefTitle': 'Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Evaluating the Implementation and Outcomes of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Collaborative Care Program in A Large, Integrated Healthcare System: A Mixed Methods Observational Study Protocol', 'orgStudyIdInfo': {'id': '1421043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Patients receiving referral to specialty mental healthcare'}, {'label': 'ADAPT', 'description': 'ADAPT', 'interventionNames': ['Behavioral: ADAPT']}], 'interventions': [{'name': 'ADAPT', 'type': 'BEHAVIORAL', 'description': 'The Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program is a novel collaborative psychiatric care model that is designed to unburden PCPs and psychiatrists, increase access to quality specialty mental healthcare for Kaiser Permanente members, and improve patient depression and anxiety treatment outcomes by utilizing technology-driven appointments. This program uses principles of collaborative care, including patient-centered care, population-based care, evidence-based care, measurement-based treatment to target, and accountable care.', 'armGroupLabels': ['ADAPT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California Division of Research', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Kathryn K Erickson-Ridout, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}