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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - Online video-based counselling
BEHAVIORAL - 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)


BEHAVIORAL: 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.

BEHAVIORAL: 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
BEHAVIORAL
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
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
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
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
Timepoint [3] 0 0
8-week follow up
Secondary outcome [4] 0 0
Client Satisfaction
Timepoint [4] 0 0
8-week follow up
Secondary outcome [5] 0 0
Client and Clinician Experiences
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2018
Sample size
Target
Accrual to date
Final
400
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/study/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/study/NCT03053934