Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT06160869
Status:
UNKNOWN
Last Update Posted:
2023-12-07
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Acceptance and Commitment Therapy on Psychotic Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'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', 'maskingDescription': 'Information is not withheld from trial participants'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Current study is an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of Acceptance and Commitment Therapy (ACT) added to treatment as usual (TAU) as opposed to treatment as usual (TAU) alone on patients with schizophrenia. The study adheres to the rules for writing Clinical Trials: "The Consolidated Standards of Reporting Trials" (CONSORT) statement'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-11-29', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': '7 weeks', 'description': 'Measuring symptom severity of patients with schizophrenia. This is a 30-item instrument. Rating of each item is from (one, no evidence) to (seven, strong evidence) and the total score for overall psychopathology ranges from 30 to 210.'}], 'secondaryOutcomes': [{'measure': 'Difficulties in Emotion Regulation Scale', 'timeFrame': '7 weeks', 'description': "A 36 item measure assesses individuals' typical levels of difficulties in emotion regulation"}, {'measure': 'Recovery Assessment Scale', 'timeFrame': '7 weeks', 'description': '38 items scale evaluate mental health recovery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychosis', 'Emotional regulation', 'Recovery'], 'conditions': ['Psychosis', 'Emotion Regulation', 'Recovery']}, 'referencesModule': {'references': [{'pmid': '39034443', 'type': 'DERIVED', 'citation': 'Zoromba MA, Sefouhi L, Alenezi A, Selim A, Awad S, El-Gazar HE, El-Monshed AH. Effectiveness of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychoses: A Randomized Controlled Trial. Int J Ment Health Nurs. 2024 Dec;33(6):2239-2256. doi: 10.1111/inm.13388. Epub 2024 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'Our study aims to assess the efficacy of Acceptance and Commitment Therapy on psychotic severity among Inpatients with primary psychosis: A Randomized Controlled Trial.', 'detailedDescription': 'Current study was an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of Acceptance and Commitment Therapy (ACT) added to treatment as usual (TAU) as opposed to treatment as usual (TAU) alone on patients with schizophrenia. The study adheres to the rules for writing Clinical Trials: "The Consolidated Standards of Reporting Trials" (CONSORT) statement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria Participants' criteria of inclusion involved those patients who were\n\n1. Current psychiatric hospitalization;\n2. DSM-5 diagnosis of a primary psychotic disorder; (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder, brief psychotic disorder, and unspeciļ¬ed psychotic disorder, this diagnosis was confirmed by a psychiatrist\n3. 18 years or older;\n4. ability to talk, read and write in Arabic; and\n5. willingness to participate in the study that was scheduled for seven weeks.\n\nExclusion criteria Patients were excluded if they\n\n1. had a comorbid learning disability or organic brain disorder;\n2. psychosis related to a general medical condition or substance-induced psychotic disorder;\n3. were considered mentally unstable; or\n4. unfit to participate in the study by their therapist, and/or had newly had (been receiving) psycho-education or somewhat designed psychosocial intervention."}, 'identificationModule': {'nctId': 'NCT06160869', 'briefTitle': 'Effect of Acceptance and Commitment Therapy on Psychotic Severity', 'organization': {'class': 'OTHER', 'fullName': 'Port Said University'}, 'officialTitle': 'Efficacy of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychosis: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'P.0553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACT Group', 'description': 'Received 90-minutes weekly group sessions of acceptence and commitment therapy plus treatment as usual.', 'interventionNames': ['Behavioral: Acceptance and commitment therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual (TAU) group', 'description': 'Will receive the TAU alone', 'interventionNames': ['Combination Product: Treatment as usual']}], 'interventions': [{'name': 'Acceptance and commitment therapy', 'type': 'BEHAVIORAL', 'description': 'The psychoeducational intervention will consist of seven structured sessions aimed at introducing patients with primary psychosis to the principles and practices of Acceptance and Commitment Therapy (ACT). The primary focus of the intervention is to empower participants to effectively manage distressing thoughts and feelings while pursuing meaningful and valued life goals. Each session covers specific aspects of ACT.\n\nAcceptance and commitment therapy will be adminitered in addition to treament as usual provided to patients.', 'armGroupLabels': ['ACT Group']}, {'name': 'Treatment as usual', 'type': 'COMBINATION_PRODUCT', 'description': 'The treatment as usual (TAU) for all patients regardless of condition will consist of hospital treatment, including daily medication management sessions with a psychiatrist (e.g., antipsychotic and other medications as appropriate), community meetings, other group therapy, case management, occupational therapy, open air walks, discharge planning, physical examination, and other services (e.g., medical testing).', 'armGroupLabels': ['Treatment as usual (TAU) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25711', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohamed Zoromba, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To ensure privacy and confidentiality of participants their data will be secured'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Port Said University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}