Viewing Study NCT05665933


Ignite Creation Date: 2025-12-25 @ 3:04 AM
Ignite Modification Date: 2025-12-31 @ 2:22 PM
Study NCT ID: NCT05665933
Status: UNKNOWN
Last Update Posted: 2023-01-05
First Post: 2022-12-07
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Acceptance and Commitment Therapy and Test Anxiety
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-23', 'releaseDate': '2024-03-26'}], 'estimatedResultsFirstSubmitDate': '2024-03-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D023801', 'term': 'Directly Observed Therapy'}], 'ancestors': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized controlled trial with pretest posttest, experimental and control groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Exam Anxiety Scale Total Score', 'timeFrame': '6 weeks', 'description': 'Change in test anxiety scale at the end of 6 weeks. The highest score from the test anxiety scale is 80 and the lowest score is 20. A high score defines high anxiety.'}, {'measure': 'Change study skills in adolescents.', 'timeFrame': '6 weeks', 'description': 'Change in test study skills scale.A maximum of 165 and a minimum of 55 points are obtained from the study skills scale. A high score defines the ability to study effectively.'}], 'secondaryOutcomes': [{'measure': 'Change the level of psychological flexibility', 'timeFrame': '6 weeks', 'description': 'Change in test psychological flexibility. A maximum of 196 and a minimum of 28 points are obtained from the psychological flexibility scale. A higher score reflects higher psychological flexibility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acceptance and commitment therapy', 'test anxiety', 'study skills', 'psychological flexibility'], 'conditions': ['Therapy, Directly Observed']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of acceptance and commitment therapy-based psychoeducation on test anxiety, study skills and psychological flexibility on adolescents. test anxiety scale, study skills scale and psychological flexibility scale are data collection tools. The pretest-posttest is a randomized controlled trial. Experimental and control groups were formed. A 6-week psychoeducation will be applied to the experimental group.', 'detailedDescription': 'The aim of this study is to determine the effect of acceptance and commitment therapy-based psychoeducation given to adolescents on test anxiety, study skills and psychological flexibility.The research was designed as a randomized controlled study with pretest, posttest, experimental and control groups aiming to examine the results of Acceptance and Commitment Therapy (ACT) based psychoeducation for test anxiety and study skills. The number of effects of the study was targeted by the randomization method among the adolescents who met the inclusion criteria and accepted the application. In the power analysis, the evaluation of the number of increase is aimed at 0.05 aggression level at the 95% confidence interval, and 52 adolescents, 26 experimental and 26 control groups, to reach 80% power. Randomization methods were used so that individuals could be assigned to the experimental groups with equal chance, similar to the scores they obtained from the laboratory test anxiety periods. 52 adolescents who met the clinical research criteria for randomization were divided into 2 groups using the irregular numbers table, this group was named as the experimental and control groups by drawing lots. The group that came out first in the lottery at this stage was accepted as the experimental group. Psychoeducation is planned to be held between December 2022 and February 2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Students' willingness to participate in research\n* Students being 11th graders\n* Getting a score of 50 or more on the test anxiety scale\n\nExclusion Criteria:\n\n* Any degree of cognitive decline or impairment\n* Presence of depressive disorder\n* Presence of serious psychiatric disorder\n* Being under treatment for a psychiatric condition"}, 'identificationModule': {'nctId': 'NCT05665933', 'briefTitle': 'Acceptance and Commitment Therapy and Test Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Artvin Coruh University'}, 'officialTitle': 'Acceptance and Commitment Therapy and Test Anxiety in Adolescents', 'orgStudyIdInfo': {'id': 'Artvin Coruh U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THE EFFECT OF ACCEPTANCE AND COMMITMENT THERAPY-BASED PSYCOEDUCATION', 'description': 'PSYCHOEDUCATION PROGRAM Total Duration: 6 Weeks Session Duration: 90 min Frequency: 1 day per week Number of People: 30', 'interventionNames': ['Behavioral: ACCEPTANCE AND COMMITMENT THERAPY-BASED PSYCOEDUCATION']}, {'type': 'NO_INTERVENTION', 'label': 'THE EFFECT OF ACCEPTANCE AND COMMITMENT THERAPY-BASED PSYCOEDUCATION ON EXAM ANXIETY IN ADOLESCENTS', 'description': 'Similar training will be provided after the study is completed. Number of People: 30'}], 'interventions': [{'name': 'ACCEPTANCE AND COMMITMENT THERAPY-BASED PSYCOEDUCATION', 'type': 'BEHAVIORAL', 'description': 'Total Duration: 6 Weeks Session Duration: 90 min Frequency: 1 day per week Number of People: 30', 'armGroupLabels': ['THE EFFECT OF ACCEPTANCE AND COMMITMENT THERAPY-BASED PSYCOEDUCATION']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Artvın', 'state': 'Center', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kubra Tan, Master', 'role': 'CONTACT', 'email': 'kubratan@artvin.edu.tr', 'phone': '+90 0466 215 1000', 'phoneExt': '6056'}, {'name': 'Ayşe Okanlı', 'role': 'CONTACT'}, {'name': 'Kubra TAN, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ayşe Okanlı, Prof.Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'ArtvinCoruhU'}, {'city': 'Artvın', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kubra Tan, Master', 'role': 'CONTACT', 'email': 'kubratan@artvin.edu.tr', 'phone': '+90 0466 215 1000', 'phoneExt': '6056'}, {'name': 'Ayşe Okanlı', 'role': 'CONTACT'}, {'name': 'Kubra TAN, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ayşe Okanlı, Prof.Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'ArtvinCoruhU'}], 'centralContacts': [{'name': 'Kübra Tan, Master', 'role': 'CONTACT', 'email': 'tankubra@hotmail.com', 'phone': '+90 5544339729'}, {'name': 'Ayşe Okanlı, Prof. Dr.', 'role': 'CONTACT', 'email': 'a.okanli@gmail.com', 'phone': '+90 5423787828'}], 'overallOfficials': [{'name': 'Kübra Tan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'https://www.artvin.edu.tr/kubra-tan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The name and results of the study will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artvin Coruh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Kubra Tan', 'investigatorAffiliation': 'Artvin Coruh University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-26', 'type': 'RELEASE'}, {'date': '2024-08-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kubra Tan, Lecturer, Artvin Coruh University'}}}}