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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] 294393 0
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 307138 0
Alcohol Use Disorder 307139 0
Condition category
Condition code
Mental Health 306259 306259 0 0
Depression
Mental Health 306260 306260 0 0
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] 300695 0
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] 305264 0
The Depression, Anxiety, Stress Scale (DASS-21) is a 21 item self-report measurement of depression, anxiety and stress.
Timepoint [1] 305264 0
12 weeks (post baseline assessment and commencement of treatment)
Primary outcome [2] 305265 0
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems.
Timepoint [2] 305265 0
12 weeks (post baseline assessment and commencement of treatment)
Primary outcome [3] 305266 0
The Opiate Treatment Index (OTI) - Alcohol scale is a self-report measure which asks about the quantity of alcohol consumed and date of consumption of the last three occasions of alcohol use within the past month. This information is used to estimate the average daily amount of alcohol consumed in the last month.
Timepoint [3] 305266 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [1] 344657 0
Quality of Life will be assessed by the EUROHIS-QOL 8-item index.
Timepoint [1] 344657 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [2] 344658 0
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ),
Timepoint [2] 344658 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [3] 344660 0
The Fagerström Test for Nicotine Dependence will be used to assess the intensity of physical addiction to nicotine. The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
Timepoint [3] 344660 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [4] 344939 0
The Opiate Treatment Index (OTI) - Tobacco, which asks about the quantity and mode of tobacco, used and date of consumption of the last three occasions of use within the past month. This information is used to estimate the average daily amount of tobacco, used in the last month.
Timepoint [4] 344939 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [5] 344940 0
The Opiate Treatment Index (OTI) – Cannabis scale, which asks about the quantity and mode of cannabis used and date of consumption of the last three occasions of use within the past month. This information is used to estimate the average daily amount of cannabis used in the last month.

Timepoint [5] 344940 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [6] 344941 0
The Opiate Treatment Index (OTI) - Amphetamines scale, which asks about the quantity and mode of amphetamines used and date of consumption of the last three occasions of use within the past month. This information is used to estimate the average daily amount of amphetamines used in the last month.
Timepoint [6] 344941 0
12 weeks (post baseline assessment and commencement of treatment)
Secondary outcome [7] 344942 0
Drug Use History will be measured by self report of first occasion, last occasion and frequency of use of a range of substances.
Timepoint [7] 344942 0
12 weeks (post baseline assessment and commencement of treatment)

Eligibility
Key inclusion criteria
Have served in the Australian Defence Forces (Army, Airforce and/or Navy);
Not currently serving (i.e. a veteran);
Current depressive symptoms measured by a DASS-21 score greater or equal to 6;
Current alcohol misuse measured by the AUDIT-C score greater or equal to 3.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not having regular access to the internet;
Not having served in the armed forces;
Still serving in the armed forces.

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)
Allocation concealment will be ensured by central randomisation using a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
150 participants will be recruited, with 75 in each experimental condition.

Descriptive and between groups analyses will be carried out.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
2/07/2018
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
1/02/2019
Actual
Sample size
Target
150
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299028 0
Charities/Societies/Foundations
Name [1] 299028 0
Defence Health Foundation
Country [1] 299028 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2038
Country
Australia
Secondary sponsor category [1] 298253 0
None
Name [1] 298253 0
Address [1] 298253 0
Country [1] 298253 0
Other collaborator category [1] 280041 0
Commercial sector/Industry
Name [1] 280041 0
ASPEN Medical
Address [1] 280041 0
Suite 17C
2 King St
Deakin
ACT 2600
Country [1] 280041 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299963 0
Department of Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 299963 0
Ethics committee country [1] 299963 0
Australia
Date submitted for ethics approval [1] 299963 0
24/01/2017
Approval date [1] 299963 0
01/06/2017
Ethics approval number [1] 299963 0
E017/001
Ethics committee name [2] 299994 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 299994 0
Ethics committee country [2] 299994 0
Date submitted for ethics approval [2] 299994 0
14/06/2017
Approval date [2] 299994 0
29/06/2017
Ethics approval number [2] 299994 0
H-2017-0179

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82102 0
A/Prof Frances Kay-Lambkin
Address 82102 0
University of Newcastle
School of Medicine and Public Health
CBMHR
PO Box 833
Newcastle
NSW 2300
Country 82102 0
Australia
Phone 82102 0
+61 416204031
Fax 82102 0
Email 82102 0
frances.kaylambkin@newcastle.edu.au
Contact person for public queries
Name 82103 0
Frances Kay-Lambkin
Address 82103 0
University of Newcastle
School of Medicine and Public Health
CBMHR
PO Box 833
Newcastle
NSW 2300
Country 82103 0
Australia
Phone 82103 0
+61 416204031
Fax 82103 0
Email 82103 0
frances.kaylambkin@newcastle.edu.au
Contact person for scientific queries
Name 82104 0
Frances Kay-Lambkin
Address 82104 0
University of Newcastle
School of Medicine and Public Health
CBMHR
PO Box 833
Newcastle
NSW 2300
Country 82104 0
Australia
Phone 82104 0
+61 416204031
Fax 82104 0
Email 82104 0
frances.kaylambkin@newcastle.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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