Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT03053934
Status:
TERMINATED
Last Update Posted:
2018-05-04
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Online Video Counselling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'whyStopped': 'Trial no longer feasible', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2017-02-12', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group x Time Interaction for overall mental health as measured by the K10 from baseline to 16-week follow up', 'timeFrame': 'Baseline, 8-week follow-up, 16-week follow-up', 'description': '0 to 16 week difference in K10 scores in group x time interaction. The Kessler Psychological Distress Scale (K10) (Kessler et al., 2002) is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4-week period.'}], 'secondaryOutcomes': [{'measure': 'Group x Time Interaction for the Outcome Rating Scale from baseline to 16-week follow up', 'timeFrame': 'Baseline, 8-week follow-up, 16-week follow-up', 'description': '0 to 16 week difference in ORS scores in group x time interaction. The Outcome Rating Scale (ORS, Miller, Duncan, Brown, Sparks, \\& Claud, 2003) will also be administered at all three time points. This is a 4-item self-report inventory that measures three different dimensions of client functioning generally considered as valid indicators of treatment progress: individual (or symptomatic) functioning, interpersonal relationships, and social role performance (work adjustment, quality of life).'}, {'measure': 'Group x Time Interaction for Quality of Life from baseline to 16-week follow up', 'timeFrame': 'Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)', 'description': '0 to 16 week difference in AQoL-8D scores in group x time interaction. The Assessment of Quality of Life-8D (AQoL-8D, Richardson et al., 2014) is a 35-item measure of health related quality of life which is sensitive to mental health issues, and is suitable for calculation of QALYs.\n\nThis measure is to be administered at all three data collection points, however, due to the length of this measure, it would be too time consuming for participants to complete this measure over the telephone. Therefore, this measure will only be completed by participants who complete the assessment online.'}, {'measure': 'Therapeutic (or Working) Alliance', 'timeFrame': '8-week follow up', 'description': "The Working Alliance Inventory - Short Revised (WAI-SR). This is a 12-item form of the WAI (Horvath \\& Greenberg, 1989). It is a self-report inventory that measures the quality of the therapeutic relationship from the client's perspective."}, {'measure': 'Client Satisfaction', 'timeFrame': '8-week follow up', 'description': 'The NHS Friends and Family Test (FFT). This is a single-item measure used to help service providers understand whether their clients are satisfied with the service provided.'}, {'measure': 'Client and Clinician Experiences', 'timeFrame': 'Up to 6 months post-treatment', 'description': 'Semi-structured interviews will also be conducted on clients and clinicians to further investigate their respective experiences with the form of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Online counselling'], 'conditions': ['Videoconferencing']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to establish whether online video counselling is at least equally acceptable and equally as effective to clients and clinicians of the Veterans and Veterans Families Counselling Service (VVCS) as in-person counselling. If this is confirmed by the evaluation then online video counselling can be made more widely available to support the veteran and ex-service community, especially for those who may otherwise be unable to attend therapy and for clients who would prefer such web-based services over in-person sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently residing in Australia\n* Eligible to receive support from the Veterans and Veterans Families Counselling Service (VVCS)\n* Aged between 18 and 65\n* Home access to broadband internet\n* Own a device (e.g., computer, laptop, or tablet) that has a webcam and can support videoconferencing\n* Be able to reasonably travel to a VVCS centre to access counselling\n* Referred for one-to-one counselling or therapy\n* Be willing and able to receive either modality of treatment (i.e., online or in-person counselling).\n\nExclusion Criteria:\n\n* Not currently residing in Australia\n* Not eligible to receive support from VVCS\n* Significant current risk issues or levels of acute distress requiring crisis management\n* Current serving member of the Australian Defence Force with a high security clearance (above Baseline Vetting)\n* Referred for couple or family counselling.\n* Have received a psychiatric diagnosis of post-traumatic stress disorder.'}, 'identificationModule': {'nctId': 'NCT03053934', 'briefTitle': 'Evaluation of Online Video Counselling', 'organization': {'class': 'OTHER', 'fullName': 'Swinburne University of Technology'}, 'officialTitle': 'Evaluation of Online Video Counselling', 'orgStudyIdInfo': {'id': 'OVC-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional in-person', 'description': 'Participants randomised to this arm will receive traditional in-person counselling (i.e., treatment will be conducted with the client and clinician occupying the same physical location/room)', 'interventionNames': ['Behavioral: Traditional in-person counselling']}, {'type': 'EXPERIMENTAL', 'label': 'Online counselling', 'description': 'Participants randomised to this arm will receive treatment from a clinician via videoconferencing (i.e., communication between the client and clinician will occur via webcam)', 'interventionNames': ['Behavioral: Online video-based counselling']}], 'interventions': [{'name': 'Online video-based counselling', 'type': 'BEHAVIORAL', 'description': 'Videoconferencing facilitates communication between individuals (i.e., the counsellor and the client) in different geographical locations enabling them to interact simultaneously with each other on a computer monitor in real time. In other words, both the client and the therapist communicate live using both visual and audio aids simulating in-person therapy albeit from two separate geographical locations.', 'armGroupLabels': ['Online counselling']}, {'name': 'Traditional in-person counselling', 'type': 'BEHAVIORAL', 'description': 'Traditional in-person counselling is often referred to as "face-to-face" and can be loosely defined as any mental health intervention, whereby the clinician is in the same room with a client. The terms "in-person" and "same room" are used less frequently, but it has been argued that these terms are more descriptive (since in videoconferencing, clients are also seen "face-to-face" on screen). Therefore, the current study uses the term "in-person" to describe traditional, face-to-face counselling.', 'armGroupLabels': ['Traditional in-person']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3029', 'city': 'Hawthorn', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Swinburne University of Technology', 'geoPoint': {'lat': -37.81992, 'lon': 145.0358}}], 'overallOfficials': [{'name': 'Denny Meyer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swinburne University of Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swinburne University of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}