NCT03053934

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

December 21, 2016

Last Update Submit

May 1, 2018

Conditions

Keywords

Online counselling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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)

  • Therapeutic (or Working) Alliance

    8-week follow up

  • Client Satisfaction

    8-week follow up

  • Client and Clinician Experiences

    Up to 6 months post-treatment

Study Arms (2)

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)

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)

Behavioral: Online video-based counselling

Interventions

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.

Online 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.

Traditional in-person

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swinburne University of Technology

Hawthorn, Victoria, 3029, Australia

Location

Study Officials

  • Denny Meyer

    Swinburne University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

February 15, 2017

Study Start

June 26, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations