VideoconferencingNCT03053934
Evaluation of Online Video Counselling
A study testing Online video-based counselling and Traditional in-person counselling in people with Videoconferencing, run by Swinburne University of Technology at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Videoconferencing
- What is being tested?
- Online video-based counselling and Traditional in-person counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Jun 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Videoconferencing
- Being tested
- Online video-based counselling, Traditional in-person counselling
- Keywords
- Online counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online video-based counsellingBehavioural
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.
Traditional in-person counsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional in-person | Active comparator | 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) Receives: Behavioral: Traditional in-person counselling |
| Online counselling | Experimental | 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) Receives: Behavioral: Online video-based counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group x Time Interaction for overall mental health as measured by the K10 from baseline to 16-week follow up
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.
Measured: Baseline, 8-week follow-up, 16-week follow-up
Secondary outcomes (5)
Group x Time Interaction for the Outcome Rating Scale from baseline to 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).
Measured: Baseline, 8-week follow-up, 16-week follow-up
Group x Time Interaction for Quality of Life from baseline to 16-week follow up
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.
Measured: Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)
Therapeutic (or Working) Alliance
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.
Measured: 8-week follow up
Client Satisfaction
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.
Measured: 8-week follow up
Client and Clinician Experiences
Semi-structured interviews will also be conducted on clients and clinicians to further investigate their respective experiences with the form of treatment
Measured: Up to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start26 Jun 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Why it stopped: Trial no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideoconferencingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swinburne University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Denny Meyer, Principal investigator, Swinburne University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053934
- Sponsor's protocol ID
- OVC-2016
- Status last verified
- May 2018
- First submitted
- 21 Dec 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Online Video Counselling
- ClinicalTrials.gov ID
- NCT03053934
- Acronym / sponsor ID
- OVC-2016
- Conditions
- Videoconferencing
- Keywords
- Online counselling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial no longer feasible
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Swinburne University of TechnologyUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional in-person | Active comparator | Behavioral: Traditional in-person counsellingParticipants 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) |
| Online counselling | Experimental | Behavioral: Online video-based counsellingParticipants randomised to this arm will receive treatment from a clinician via videoconferencing (i.e., communication between the client and clinician will occur via webcam) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online video-based counsellingVideoconferencing 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. | Behavioural | Online counselling |
| Traditional in-person counsellingTraditional 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. | Behavioural | Traditional in-person |
Primary outcome
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
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.
5 secondary outcomes
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
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)
Therapeutic (or Working) Alliance
Time frame: 8-week follow up
Client Satisfaction
Time frame: 8-week follow up
Client and Clinician Experiences
Time frame: Up to 6 months post-treatment
Results and safety
The study was stopped early (reason given: Trial no longer feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denny Meyer principal investigator
Swinburne University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online video-based counselling and Traditional in-person counselling in people with Videoconferencing, run by Swinburne University of Technology at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Trial no longer feasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.