ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000460202

Ethics application status

Approved

Date submitted

22/03/2018

Date registered

29/03/2018

Date last updated

10/08/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

vSHADE - An internet-delivered, evidenced-based treatment program for mental health and alcohol use in contemporary Veterans

Scientific title

An internet-delivered, evidenced-based treatment program for mental health and alcohol use in contemporary Veterans - SHADE

Secondary ID [1]

University of Newcastle - G1600670

Universal Trial Number (UTN)

U1111-1211-2026

Trial acronym

vSHADE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Alcohol Use Disorder

Condition category

Condition code

Mental Health

Depression

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will all have online access to the SHADE program (10 modules) for a period of 12 weeks. SHADE was developed by our team and is the first evidence-based internet-delivered cognitive behavioural therapy (CBT) treatment for comorbid depression and alcohol/other drug use problems, which has been evaluated relative to extended face-to-face traditional cognitive behaviour therapy (CBT) in two randomised controlled trials.
Half of the participants will be randomly allocated to also have access to the Breathing Space social network for a period of 12 weeks. Breathing Space is a private, closed, purpose-built social networking app, developed and designed by our research group. Only participants in this project, and research staff will have access to the closed group. The site will be moderated by research staff, including Clinical Psychologists and Psychologists.
SHADE is a 10 module CBT intervention which participants can complete at their own pace and discretion. Each module should take around an hour to complete. As with traditional therapist delivered CBT, SHADE computer modules are delivered according to the following structure: setting the agenda for the current session, reviewing homework activities, learning/developing new skills, assigning homework and conclusion.
Module 1 includes an Introduction of 5-10 minutes that orients the person to the computer program, shows them how to use the mouse and keyboard, and teaches them how to navigate their way through the program. In Module 1 participants will: Learn to examine their own story and learn how to evaluate life events (“hurdles and ladders”) that have led to their current situation; Learn important information about alcohol, drugs and depression; and begin to learn how to identify the pros and cons of using.
In Module 2, participants will In this session, clients will: learn to develop an activity log, to monitor the things they are currently doing in everyday life; learn to examine the costs of drinking/using (including job, finances, personal, health); and learn about “mindful awareness”.
In Module 3, participants will: learn how thoughts and behaviours are linked; learn to analyse pros and cons balance in regard to changing their situation; and learn to experience routine activities in a mindful way.
In Module 4, participants will: learn to use their “activity log” to schedule one pleasant and one achievement activity into each day; learn more about their experience of cravings and impulses; and develop a plan for changing their current situation.

In Module 5, participants will: learn about problematic patterns of thinking common to depression and using alcohol/other drug; learn to manage these problematic patterns; and develop mindfulness skills.
In this Module 6, participants will: learn problem solving skills; and develop mindfulness skills.
In Module 7 participants will: learn about the concept of a schema; identify their own problematic schema; and learn how to develop an alternative, more balanced schema.
In Module 8, participants will: learn how to use mindfulness as a strategy to help cope with unpleasant thoughts, feelings and events; learn the skills to effective refuse offers of alcohol/other drug; and develop and emergency craving plan to help manage real-life high-risk situations for alcohol/other drug use.
In Module 9, participants will: start to prepare for life outside of SHADE therapy; learn about “seemingly irrelevant decisions”; learn to identify and manage the ”breaking the rule” effect; and learn how to look after their wellbeing.
In Module 10, participants will: learn about the importance of relapse prevention; and develop their own relapse management and prevention plan.
Participant adherence to the intervention will be monitored through website analytics that provide details about frequency and duration of log ins and pages visited for each participant.
Breathing Space is a purpose built social networking app where participants who are allocated into the SHADE + Breathing Space intervention of the vSHADE project can obtain support and encouragement from other people who are interested in making changes to their drinking and Depression. It is an opportunity for participants to discuss things that they have learned during the vSHADE project, ask questions and share/receive useful information from others in a safe and supportive environment. This is done through status updates, longer posts and replies to posts from other participants.
Breathing Space is a private social networking site, and as such, only participants who have been allocated to the SHADE + Breathing Space intervention can participate. The site and any of its contents will not be publically visible on the internet and can only be viewed by participants and clinical research staff employed on the project.
Eligible participants of the vSHADE study will be given access to the Breathing Space social networking app for a period of 12 weeks. The site is available 24 hours, and participants can write a post anytime. However, it is made clear that the site is not monitored by the Clinical Psychologist moderators 24/7, and that they are only available to help with any immediate concerns in normal working hours (Mon-Fri 9am-5pm), and therefore, if participants are in a crisis, they are to use the emergency numbers provided on the Crisis tab.
There is no maximum or minimum frequency or duration of participation however participants will receive weekly e-mail or SMS (as per their preference) reminders about the vSHADE study. The number of participants using Breathing Space at any given time will vary between 1-75 plus the research team and site moderators who will also post. Usage of the site will be measured using computer analytics.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control Evidence based SHADE treatment is being compared to SHADE with Breathing Space social networking support.

Control group

Active

Outcomes

Primary outcome [1]

The Depression, Anxiety, Stress Scale (DASS-21) is a 21 item self-report measurement of depression, anxiety and stress.

Timepoint [1]