- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03053934
Evaluation of Online Video Counselling
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Victoria
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Hawthorn, Victoria, Australia, 3029
- Swinburne University of Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently residing in Australia
- Eligible to receive support from the Veterans and Veterans Families Counselling Service (VVCS)
- Aged between 18 and 65
- Home access to broadband internet
- Own a device (e.g., computer, laptop, or tablet) that has a webcam and can support videoconferencing
- Be able to reasonably travel to a VVCS centre to access counselling
- Referred for one-to-one counselling or therapy
- Be willing and able to receive either modality of treatment (i.e., online or in-person counselling).
Exclusion Criteria:
- Not currently residing in Australia
- Not eligible to receive support from VVCS
- Significant current risk issues or levels of acute distress requiring crisis management
- Current serving member of the Australian Defence Force with a high security clearance (above Baseline Vetting)
- Referred for couple or family counselling.
- Have received a psychiatric diagnosis of post-traumatic stress disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Traditional in-person
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)
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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.
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EXPERIMENTAL: Online counselling
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)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group x Time Interaction for overall mental health as measured by the K10 from baseline to 16-week follow up
Time Frame: Baseline, 8-week follow-up, 16-week follow-up
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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.
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Baseline, 8-week follow-up, 16-week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group x Time Interaction for the Outcome Rating Scale from baseline to 16-week follow up
Time Frame: Baseline, 8-week follow-up, 16-week follow-up
|
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).
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Baseline, 8-week follow-up, 16-week follow-up
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Group x Time Interaction for Quality of Life from baseline to 16-week follow up
Time Frame: Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)
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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. This 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. |
Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)
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Therapeutic (or Working) Alliance
Time Frame: 8-week follow up
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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.
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8-week follow up
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Client Satisfaction
Time Frame: 8-week follow up
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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.
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8-week follow up
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Client and Clinician Experiences
Time Frame: Up to 6 months post-treatment
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Semi-structured interviews will also be conducted on clients and clinicians to further investigate their respective experiences with the form of treatment
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Up to 6 months post-treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Denny Meyer, Swinburne University of Technology
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OVC-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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