Evaluation of Online Video Counselling

Sponsor

Swinburne University of Technology (Other)

Overall Status

Terminated

CT.gov ID

NCT03053934

Collaborator

US Department of Veterans Affairs (U.S. Fed)

400

Enrollment

Location

Arms

9.2

Actual Duration (Months)

43.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Videoconferencing	Behavioral: Online video-based counselling Behavioral: Traditional in-person counselling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Evaluation of Online Video Counselling

Actual Study Start Date :

Jun 26, 2017

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

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)	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.
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.

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)

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.

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.

Outcome Measures

Primary Outcome Measures

Group x Time Interaction for overall mental health as measured by the K10 from baseline to 16-week follow up [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.

Secondary Outcome Measures

Group x Time Interaction for the Outcome Rating Scale from baseline to 16-week follow up [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).
Group x Time Interaction for Quality of Life from baseline to 16-week follow up [Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)]
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.
Therapeutic (or Working) Alliance [8-week follow up]
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.
Client Satisfaction [8-week follow up]
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.
Client and Clinician Experiences [Up to 6 months post-treatment]
Semi-structured interviews will also be conducted on clients and clinicians to further investigate their respective experiences with the form of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swinburne University of Technology	Hawthorn	Victoria	Australia	3029

Sponsors and Collaborators

Swinburne University of Technology
US Department of Veterans Affairs

Investigators

Principal Investigator: Denny Meyer, Swinburne University of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Swinburne University of Technology

ClinicalTrials.gov Identifier:

NCT03053934

Other Study ID Numbers:

OVC-2016

First Posted:

Feb 15, 2017

Last Update Posted:

May 4, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Swinburne University of Technology

Online counselling

Study Results

No Results Posted as of May 4, 2018