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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03053934




Registration number
NCT03053934
Ethics application status
Date submitted
21/12/2016
Date registered
15/02/2017
Date last updated
4/05/2018

Titles & IDs
Public title
Evaluation of Online Video Counselling
Scientific title
Evaluation of Online Video Counselling
Secondary ID [1] 0 0
OVC-2016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Videoconferencing 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Online video-based counselling
Behaviour - Traditional in-person counselling

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)

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)


Behaviour: Online video-based counselling
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.

Behaviour: Traditional in-person counselling
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.

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, 8-week follow-up, 16-week follow-up
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Baseline, 8-week follow-up, 16-week follow-up
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
8-week follow up
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
8-week follow up
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to 6 months post-treatment

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
3029 - Hawthorn

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
US Department of Veterans Affairs
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/show/NCT03053934
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Denny Meyer
Address 0 0
Swinburne University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03053934