Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000366954
Ethics application status
Approved
Date submitted
24/02/2020
Date registered
16/03/2020
Date last updated
2/03/2021
Date data sharing statement initially provided
16/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An internet-delivered, evidenced-based treatment program for mental health and alcohol use in Older Australians
Scientific title
A randomised control trial of a targeted intervention program for reducing depression, alcohol use, social isolation and suicide in older Australians: The SHADEPlus trial
Secondary ID [1] 300410 0
Nil Known
Universal Trial Number (UTN)
U1111-1248-6874
Trial acronym
SHADEPlus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 316053 0
Suicide 316054 0
Alcohol Misuse 316055 0
Condition category
Condition code
Mental Health 314326 314326 0 0
Addiction
Mental Health 314327 314327 0 0
Suicide
Mental Health 314328 314328 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who join the research study will be randomly allocated to 1 of 2 treatment conditions;
1. BreathingSpace + 10 weekly brief telephone check in's (n = 75), or
2. BreathingSpace + SHADE + 10 weekly brief telephone check in's (n = 75).
Following randomisation study participants will be given the option of receiving a brief introductory telephone call (10 minutes) to orient them to the style of intervention, introduce them to the program/s they have been allocated, and assist initial engagement with the BreathingSpace app and online programs by provision of technical support.

BreathingSpace
Breathing Space is a private, purpose built online social network in app form developed by the research team. Only participants who complete the screening assessment and are deemed eligible to participate in the study will have access to the BreathingSpace community. Eligible participants will have the choice of to join the research part of the study, or just join BreathingSpace. As such, the BreathingSpace online community will consist of older Australians who meet the eligibility criteria for study participation, including both non-study participants and those in the research study. The site and any of its contents will not be publicly visible on the internet and can only be viewed by participants and clinical research staff employed on the project.

BreathingSpace will be similar in function to a Facebook group (except that it will be anonymous) enabling participants to post their thoughts, messages of support, update their status, share their experiences, and report on progress related to their mood and alcohol use. The site will be moderated by clinicians including Psychologists, Clinical Psychologists and Social Workers. Moderators will also be responsible for posting regular content to stimulate discussion ( 2-3 times per week) and assist in online community engagement. 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 moderators 24/7, and that they are only available to help with any immediate concerns in normal working hours (Mon-Fri 9am-5pm). Therefore, if participants are in a crisis, they are to use the emergency numbers provided on the Crisis tab. Eligible participants will be given access to the BreathingSpace social network for 12 weeks.
The number of participants using Breathing Space at any given time will vary between 1 to > 150 plus the research team and site moderators who will also participate in the community. Usage of the site will be measured using computer analytics.

Participant use of the BreathingSpace app is at their own discretion. Particpants can log in as little or as often as they would like. Participants will be sent email notifications to log into the community if they have not logged into BreathingSpace after one week.

BreathingSpace analytics will collect information on number of log in's, time spent on the app, number of posts made etc. These analytics will provide some information about overall use of the app.

SHADE
SHADE- Is a 10-session evidence based program of web-based intervention for problematic alcohol use and depressed mood. SHADE consists of information and interactive components, including case vignettes, in-session exercises and homework activities which participants can access via the internet, computer or smartphone. SHADE is comprised of 10 individual treatment modules each designed to be completed at a rate of one module per week ( taking approximately 1 hour to complete). The treatment modules are designed to be done in order, and while participants will have access to all modules at commencement they are advised to complete them sequentially. The treatment uses cognitive behaviour therapy (CBT), motivational interviewing techniques and mindfulness based stress reduction.
SHADE was developed by our team and is the first evidence-based internet-delivered cognitive behavioural therapy (CBT) treatment for co-morbid 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.

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. Homework activities are completed at each session and are designed to help the participant build on skills learned within session. Individual modules are described below:

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.Home work tasks include reviewing the case formulation and the decisional balance sheet that was completed within session and to consider how they might address some of their concerns.

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”. Homework tasks include completing a mood monitor, mindfulness activity and activity log each day.

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. Homework tasks include completion of a daily thought monitor, mindfulness activity and their activity log.

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. Homework tasks include completion of thought monitoring, activity log and experimenting with modification of their alcohol use utilising skills developed within session.

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. Homework tasks include continuing with the daily activity log, mindfulness activities, and thought management activities.

In this Module 6, participants will: learn problem solving skills; and develop mindfulness skills. Homework activities include consolidating skills developed in previous sessions and practising problem solving using a real life example.

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. Homework tasks include skill consolidation and the use of an alternative view worksheet to assist participants to develop alternative views to their current schemas.

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. Homework activities include continued skill consolidation and practice of refusal skills in challenging situations.

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. Homework tasks include skill consolidation of all skills developed in previous sessions, and use of emergency planning worksheet when required.

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. Honework activities at the conclusion of the program include a discussion on what skills participants would like to utilise independently at the completion of program, and to develop a plan for incorporating these activities.

Brief weekly telephone check- in
All study participants, regardless of treatment allocation will receive 10 weekly brief telephone check in's.
Weekly check in phone calls will be brief (10- 15 minutes duration) and will cover topics including mood assessment (and suicide risk assessment if required), their use of SHADE and/or Breathing Space, including any set homework activities (SHADE only) and support for any program related issues.
Telephone interaction with the participant will be used to guide impressions of current mood, but participants will also be asked more directly about their mood/suicidal ideation, and via completion of a formal mood assessment if required.



Intervention code [1] 316700 0
Treatment: Other
Intervention code [2] 317077 0
Behaviour
Comparator / control treatment
An active comparator control group will be used in the current study.

Participants will be randomly allocated to one of two treatment conditions. See below:
1. Breathing Space + 10 weekly brief telephone check in's (comparator)
2. BreathingSpace + SHADE + 10 weekly brief telephone check in's (intervention)

These conditions are already described above in "Description of intervention/exposure"
Control group
Active

Outcomes
Primary outcome [1] 322840 0
The Geriatric Depression Scale (short form) is a 15-item screening tool used to identify depression in older adults.
Timepoint [1] 322840 0
This is completed at the time of the screening assessment for study entry and follow up assessment time points at 12 and 26 weeks post baseline assessment.
Primary outcome [2] 322841 0
The short Michigan Alcoholism Screening test- Geriatric Version (sMAST) is 10 item screening test to identify alcoholism in older adults.
Timepoint [2] 322841 0
This is completed at the time of the screening assessment for study entry and follow up assessment time points at 12 and 26 weeks post baseline assessment.
Primary outcome [3] 322842 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] 322842 0
This is completed at baseline and 12 and 26 weeks post baseline
Secondary outcome [1] 379981 0
The SIDAS is designed to screen individuals in the community for presence of suicidal thoughts and assess the severity of these thoughts. It consists of five items, each targeting an attribute of suicidal thoughts: frequency, controllability, closeness to attempt, level of distress associated with the thoughts and impact on daily functioning. Responses are measured on a 10-point scale.
Timepoint [1] 379981 0
This is completed at baseline and 12 and 26 weeks post baseline
Secondary outcome [2] 379982 0
The WHOQOL-OLD is a multidimensional measure of quality of life in older persons and comprises 24 items divided into six facets or subscales of four items each. These facets are sensory abilities, autonomy, past, present, and future activities, social participation, death and dying, and intimacy.
Timepoint [2] 379982 0
This is completed at baseline and 12 and 26 weeks post baseline.
Secondary outcome [3] 379983 0
The UCLA 3 Item Loneliness Scale comprises 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation.
Timepoint [3] 379983 0
This is completed at baseline and 12 and 26 weeks post baseline.

Eligibility
Key inclusion criteria
1) 60 years of age or older;
2) Current depressive symptoms (score 5+ on the Geriatric Depression Scale, GDS);
3) Current risky alcohol consumption (score of 2 or more on the short Michigan Alcoholism Screening Test – Geriatric Version, sMAST-GV);
4) Ability and willingness to access the internet.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current, acute, high risk of suicide, as measured by the 5-item subscale of the GDS;
2) Acquired brain injury/significant cognitive impairment/insufficient English to prevent informed consent and understand the interventions;
3) Acute psychotic symptoms. Ineligible participants will be provided with referral options.

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.
The data will be analysed using an intention-to-treat design.
Social network analysis will be done at baseline, 12 week and 26-week follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2021
Actual
Date of last participant enrolment
Anticipated
1/09/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304832 0
Charities/Societies/Foundations
Name [1] 304832 0
Suicide Prevention Australia
Country [1] 304832 0
Australia
Primary sponsor type
Individual
Name
Professor Frances Kay-Lambkin
Address
School of Medicine and Population Health
University of Newcastle
University Drive
CALLAGHAN 2308 NSW
Australia
Country
Australia
Secondary sponsor category [1] 305293 0
None
Name [1] 305293 0
Address [1] 305293 0
Country [1] 305293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305243 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 305243 0
Ethics committee country [1] 305243 0
Australia
Date submitted for ethics approval [1] 305243 0
28/02/2020
Approval date [1] 305243 0
01/06/2020
Ethics approval number [1] 305243 0
H-2020-0077

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

Contacts
Principal investigator
Name 99742 0
Prof Frances Kay-Lambkin
Address 99742 0
School of Medicine and Public Health
Centre for Brain and Mental Health Research (CBMHR)
PO Box 833
Newcastle
NSW 2300
Country
Australia
Country 99742 0
Australia
Phone 99742 0
+61 2 4921 6023
Fax 99742 0
+61 2 4033 5692
Email 99742 0
[email protected]
Contact person for public queries
Name 99743 0
Frances Kay-Lambkin
Address 99743 0
School of Medicine and Public Health
Centre for Brain and Mental Health Research (CBMHR)
PO Box 833
Newcastle
NSW 2300
Country
Australia
Country 99743 0
Australia
Phone 99743 0
+61 2 4921 6023
Fax 99743 0
61 2 4033 5692
Email 99743 0
[email protected]
Contact person for scientific queries
Name 99744 0
Frances Kay-Lambkin
Address 99744 0
School of Medicine and Public Health
Centre for Brain and Mental Health Research (CBMHR)
PO Box 833
Newcastle
NSW 2300
Country
Australia
Country 99744 0
Australia
Phone 99744 0
+61 2 4921 6023
Fax 99744 0
+61 2 4033 5692
Email 99744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.