Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT06555094
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072860', 'term': 'Ecological Momentary Assessment'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Within-person changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment) from pre- to post-EMI', 'timeFrame': 'Through study completion (up to 28 days after inpatient hospital discharge)', 'description': 'Overall changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) from pre- to post-EMI use, among those in the experimental condition only'}, {'measure': 'Between-condition differences in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment)', 'timeFrame': 'Through study completion (up to 28 days after inpatient hospital discharge)', 'description': 'Means and slopes of momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) will be compared between the experimental and control conditions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide Attempt', 'Suicide', 'Suicidal Ideation', 'Unified Protocol', 'Ecological Momentary Intervention', 'mhealth'], 'conditions': ['Suicidal Ideation', 'Suicide', 'Suicide Attempt']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.', 'detailedDescription': 'This study is a companion project to NCT05848089. The present study is a two-arm parallel design RCT to test the efficacy of using ecological momentary intervention (EMI) to deliver therapeutic content based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) - an evidence-based transdiagnostic cognitive behavioral therapy (CBT) that focuses on delivering adaptive skills for managing strong emotions. Participants in this study will be 50 adult psychiatric inpatients with recent suicidal thoughts or behaviors (STBs). Participants will be randomized to receive either the control condition, which consists of treatment as usual (TAU; n = 25) and 4x/daily daily ecological momentary assessment (EMA) of emotions and STBs, or the experimental condition, consisting of TAU, 4x/daily EMA, 3 brief sessions to deliver CBT skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors, all drawn from the UP), and EMI to prompt guided skills practice (n = 25).\n\nControl participants will receive TAU and be prompted to complete 4x/day EMA of emotions and STBs for the duration of their hospital stay and the 28-day post-discharge period. Participants randomized to the experimental conditions will receive TAU plus three brief treatment sessions delivering core UP skills content (during inpatient stays) that may be offered after discharge via either phone or telehealth. Those in the experimental condition will also receive training to use the EMI (which prompts guided skills practice), followed by smartphone-based for the 28-day post-discharge period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult status (18+ years),\n* a recent suicide attempt or any report of current suicidal ideation,\n* the ability to speak and write English fluently, ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone), and\n\nExclusion criteria:\n\n\\- the presence of any factor that impairs an individual\\'s ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.'}, 'identificationModule': {'nctId': 'NCT06555094', 'briefTitle': 'Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Supplementing Brief Psychotherapy With a Mobile App', 'orgStudyIdInfo': {'id': 'Pro2022001944_mod6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment as usual (TAU) + EMA', 'description': 'Participants will receive TAU and be prompted to complete 4x/day smartphone-based EMA surveys of negative emotion and STBs.', 'interventionNames': ['Behavioral: Ecological momentary assessment (EMA)', 'Behavioral: Treatment as usual (TAU)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental intervention + TAU', 'description': 'Participants will receive TAU plus 3 brief sessions of CBT skills, one discretionary post-discharge skills booster session, and 4x/day EMA and prompted EMI, which guides in-the-moment CBT skills practice.', 'interventionNames': ['Behavioral: Treatment as usual (TAU)', 'Behavioral: Brief skills sessions plus EMI skills practice prompts']}], 'interventions': [{'name': 'Ecological momentary assessment (EMA)', 'type': 'BEHAVIORAL', 'description': '4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs', 'armGroupLabels': ['Treatment as usual (TAU) + EMA']}, {'name': 'Treatment as usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'TAU (or usual care) during hospitalization and the 28-day post-discharge period', 'armGroupLabels': ['Experimental intervention + TAU', 'Treatment as usual (TAU) + EMA']}, {'name': 'Brief skills sessions plus EMI skills practice prompts', 'type': 'BEHAVIORAL', 'otherNames': ['cognitive behavioral therapy', 'ecological momentary intervention'], 'description': '(1) Three brief treatment sessions delivering core cognitive behavioral therapy (CBT) skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors) (during hospitalization), (2) a discretionary booster session to reinforce treatment session content (that may be offered after discharge via either phone or telehealth), and (3) ecological momentary intervention (EMI) prompts to engage in guided skills practice exercises via smartphone', 'armGroupLabels': ['Experimental intervention + TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Evan Kleiman', 'role': 'CONTACT', 'email': 'evan.kleiman@rutgers.edu'}, {'name': 'Evan Kleiman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rutgers University Behavioral Healthcare', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'centralContacts': [{'name': 'Evan Kleiman, Ph.D.', 'role': 'CONTACT', 'email': 'evan.kleiman@rutgers.edu', 'phone': '1-848-445-2345'}], 'overallOfficials': [{'name': 'EVAN KLEIMAN, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'These data are from a sensitive, high-risk population'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Evan M. Kleiman, Ph.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}