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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03053934
Other study ID # OVC-2016
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 26, 2017
Est. completion date April 1, 2018

Study information

Verified date May 2018
Source Swinburne University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 400
Est. completion date April 1, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Australia Swinburne University of Technology Hawthorn Victoria

Sponsors (2)

Lead Sponsor Collaborator
Swinburne University of Technology Department of Veterans' Affairs

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 8-week follow-up, 16-week follow-up
Secondary 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). Baseline, 8-week follow-up, 16-week follow-up
Secondary 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.
Baseline, 8-week follow-up, 16-week follow-up (only administered to participants completing the survey online)
Secondary 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. 8-week follow up
Secondary 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. 8-week follow up
Secondary 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 Up to 6 months post-treatment
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