Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06150118
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2023-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-Injury Anxiety Inventory (RIAI)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'This scale measures re-injury anxiety'}, {'measure': 'Sport Injury Rehabilitation Adherence Scale (SIRAS)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'This scale measures rehabilitation adherence'}, {'measure': 'Athletic Injury Self-Efficacy Questionnaire (AISEQ)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'This scale measures Self-Efficacy'}, {'measure': 'Tampa Scale for Kinesiophobia', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'This scale measures kinesiophobia'}, {'measure': 'Return to Sport After Serious Injury Questionnaire (RSSIQ)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'This scale was used to assess whether athletes were psychologically ready to return to sport.'}, {'measure': 'Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'This scale was used to assess whether athletes were psychologically ready to return to sport from ACL surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Re-injury anxiety', 'Adherence', 'Self-efficacy', 'Kinesiophobia', 'psychological readiness to return to sport'], 'conditions': ['Re-injury Anxiety', 'Kinesiophobia', 'Poor Rehabilitation Adherence', 'Poor Rehabilitation Self Efficacy', 'Return to Sport']}, 'descriptionModule': {'briefSummary': 'In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The effectiveness of the protocol was assessed using pre-test, post-test, and two follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).', 'detailedDescription': 'In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The protocol was developed in 5 stages and a randomized controlled trial was conducted with 36 athletes to test its effectiveness. The study consisted of 1 experimental and 2 control groups. One of the control group was a plasebo control group.The effectiveness of the protocol was assessed using pre-test, post-test, and follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Have had an ACL injury operation\n* Be between the ages of 18 and 45\n* To be a professional athlete in Turkish leagues\n* Being an athlete in football, volleyball, and basketball\n\nExclusion Criteria:\n\n* Having a discomfort that prevents participants from participating in VR sessions (panic attack, epilepsy, etc.)\n* Having decided to quit sports even if participants will continue rehabilitation after the operation'}, 'identificationModule': {'nctId': 'NCT06150118', 'acronym': 'CBT+VR', 'briefTitle': 'The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Supporting Physical Rehabilitation After Anterior Cruciate Ligament (ACL) Operation: A Parallel-Arm Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '121K248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT+VR (Cognitive behavioral therapy and virtual reality)', 'interventionNames': ['Other: CBT+VR (Cognitive behavioral therapy and virtual reality)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Behavioral: Control (placebo) group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This arm have no intervention during the research. They only had been followed up by researchers'}], 'interventions': [{'name': 'CBT+VR (Cognitive behavioral therapy and virtual reality)', 'type': 'OTHER', 'description': 'The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.', 'armGroupLabels': ['CBT+VR (Cognitive behavioral therapy and virtual reality)']}, {'name': 'Control (placebo) group', 'type': 'BEHAVIORAL', 'description': 'The investigators are testing whether the placebo control protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Ziya Koruç, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Britton W. Brewer, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Springfield College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hande Turkeri Bozkurt', 'investigatorAffiliation': 'Hacettepe University'}}}}