Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT04635618
Status:
UNKNOWN
Last Update Posted:
2020-11-19
First Post:
2020-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three-arm randomized clinical trial , including professionals and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak randomized 1:1:1: to the Cognitive Behavioral Brief-Telepsychotherapy group (B-CBT, four sessions), Brief Interpersonal Telepsychotherapy (B-IPT, four sessions) or Telepsychoeducation group (a single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 999}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Reduction at 1-month', 'timeFrame': '1-month', 'description': 'Proportion of participants with a 50% reduction in T-scores at 1-month in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline.'}], 'secondaryOutcomes': [{'measure': 'Symptom Reduction at 3 and 6-months follow-up', 'timeFrame': '3 and 6-month', 'description': 'Proportion of participants with a 50% reduction in T-scores at 3 and 6-months follow-up in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline measured'}, {'measure': 'Remission Levels in distress scales', 'timeFrame': '1, 3 and 6-months', 'description': 'Remission levels (proportion of patients with T-score of 50 or below) in distress scales (PROMIS of Depression, Anxiety and Anger)'}, {'measure': 'Service Satisfaction', 'timeFrame': '1-month', 'description': 'Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)'}, {'measure': 'Improvement in Quality of Life', 'timeFrame': '1, 3 and 6-months', 'description': 'Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Disorder', 'COVID', 'Emotional Distress', 'Depression', 'Anxiety', 'Irritable Mood']}, 'referencesModule': {'references': [{'pmid': '40455512', 'type': 'DERIVED', 'citation': 'Martins DS, Viduani A, Dreher CB, Salum G, Manfro GG. Examining therapeutic alliance, adherence, and dropout in brief telepsychotherapy: A qualitative study. J Couns Psychol. 2025 Nov;72(6):699-709. doi: 10.1037/cou0000806. Epub 2025 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control.\n\nNote: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.', 'detailedDescription': 'PRAGMATIC TREATMENT TRIAL\n\nTITLE: "A pragmatic superiority randomized controlled trial comparing Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation for the reduction of emotional distress during COVID-19 outbreak in professionals and students from essential services with a high level of emotional distress in Brazil".\n\nIMPORTANCE: COVID-19 outbreak is associated with increased emotional distress (depression, anxiety, and irritability) all over the world. Currently, there are no large randomized trials testing interventions to reduce the burden caused by mental disorders during a pandemic outbreak of these proportions.\n\nOBJECTIVE: To test the effectiveness of two modalities of Brief-Telepsychotherapy (Cognitive Behavioral and Interpersonal) to the reduction of symptoms of emotional distress (anxiety, depression, and irritability) in professionals and students from essential services with a high level of those symptoms in Brazil during the COVID-19 outbreak.\n\nDESIGN, SETTING, AND PARTICIPANTS Thee-arm randomized clinical trial. Participants were recruited in Brazil from the national service of telehealth provided by the ministry of health. Participants included professional and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak. High levels of symptoms were defined by either of the following: (1) T score higher than 70 on the PROMIS Anxiety Scale; (2) T score higher than 70 on the PROMIS Depression Scale; (3) T score higher than 70 on the PROMIS Anger Scale.\n\nINTERVENTIONS: All participants will be randomized 1:1:1: to the Cognitive Behavioral Brief-Telepsychotherapy group (B-CBT, four sessions), Brief Interpersonal Telepsychotherapy (B-IPT, four sessions) or Telepsychoeducation group (a single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks).\n\nMAIN OUTCOMES AND MEASURES: The primary outcome will be the proportion of participants with a 50% reduction in T-scores in all the scales that were scored above 70 at baseline at 1-month. Secondary outcomes (1) the same measure of the primary outcome but measured at 3-month and 6-months follow-up; (2) mean score change in individual scales, quality of life and remission levels (proportion of patients with T-score of 50 or below in all of the four emotional distress subscales); (3) the same measure of the primary outcome but measured at midpoint (after the second session or 2-weeks); and (4) service satisfaction and net-promoter score at the end of the treatment.\n\nEXPECTED RESULTS: To detect a 15% group difference between each group, an alpha of 0.017 (3 comparisons, 0,05/3), power of 90%, and 20% loss to follow up, we would need a total of 333 participants per group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProfessionals and students from essential services suffering from high levels of emotional distress\n\n* T score higher than 70 on the PROMIS Anxiety Scale\n* T score higher than 70 on the PROMIS Depression Scale\n* T score higher than 70 on the PROMIS Anger Scale\n\nExclusion Criteria:\n\n* Moderate to severe suicide risk assessed by a psychiatrist'}, 'identificationModule': {'nctId': 'NCT04635618', 'briefTitle': 'Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'A Pragmatic Superiority Randomized Controlled Trial Comparing Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation for the Reduction of Emotional Distress During COVID-19 Outbreak in Professionals and Students From Essential Services With a High Level of Emotional Distress in Brazil in the Context of COVID-19', 'orgStudyIdInfo': {'id': '20200213_Treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention I: Cognitive Behavioral Brief-Telepsychotherapy', 'description': 'Four sessions of cognitive-behavioral therapy (CBT) conducted through a video call by a psychologist, accompanied by sending videos of 2 to 3 minutes with psychoeducational content and content related to CBT technique.', 'interventionNames': ['Behavioral: Cognitive Behavioral Brief-Telepsychotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention II: Brief Interpersonal Telepsychotherapy', 'description': 'Four sessions of interpersonal therapy (IPT) conducted by video call by a psychologist, accompanied by the sending of 2 to 3 minute videos with psychoeducational content and content related to the ITP technique.', 'interventionNames': ['Behavioral: Brief Interpersonal Telepsychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Telepsychoeducation group', 'description': 'One single session of psychoeducation conducted through a video call by a psychologist, accompanied by sending videos of 2 to 3 minutes with psychoeducational content for 4 weeks.', 'interventionNames': ['Behavioral: Telepsychoeducation']}], 'interventions': [{'name': 'Cognitive Behavioral Brief-Telepsychotherapy', 'type': 'BEHAVIORAL', 'description': 'Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos', 'armGroupLabels': ['Intervention I: Cognitive Behavioral Brief-Telepsychotherapy']}, {'name': 'Brief Interpersonal Telepsychotherapy', 'type': 'BEHAVIORAL', 'description': 'Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos', 'armGroupLabels': ['Intervention II: Brief Interpersonal Telepsychotherapy']}, {'name': 'Telepsychoeducation', 'type': 'BEHAVIORAL', 'description': 'A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks', 'armGroupLabels': ['Active Comparator: Telepsychoeducation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Giovanni Salum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Avaliable six months after study completion (antecipated - January 2022)', 'ipdSharing': 'YES', 'description': 'Plan to share study protocol, SAP, ICF, CRS, analytic code and individual-based variables.', 'accessCriteria': 'Researchers and civil society'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giovanni Abrahao Salum Junior', 'investigatorAffiliation': 'Hospital de Clinicas de Porto Alegre'}}}}