Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000786998
Ethics application status
Approved
Date submitted
3/07/2020
Date registered
4/08/2020
Date last updated
4/08/2020
Date data sharing statement initially provided
4/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Digital Companion for Loneliness During the COVID-19 Pandemic: A Feasibility Study
Scientific title
A Digital Companion for Loneliness During the COVID-19 Pandemic: A Feasibility Study
Secondary ID [1] 301673 0
Nil known
Universal Trial Number (UTN)
U1111-1252-6680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loneliness 318113 0
Stress 318114 0
Condition category
Condition code
Mental Health 316133 316133 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to the digital companion intervention or a waitlist control group. Participants in the intervention group will be required to interact with a digital companion daily for at least 15 minutes per day over a one-week period. The digital companion will be a digital human, which is an animated, embodied conversational agent that uses artificial intelligence to provide social and emotional engagement. The interaction will involve completing two ‘resilience’ module with a digital companion. One module includes the following loneliness intervention techniques: increasing social support, increasing opportunity for social interaction, and increasing social skills. For example, participants will be encouraged to contact someone from their existing social network. A second 'resilience' module includes techniques for reducing loneliness-related distress such as psychoeducation about coping skills and a deep breathing exercise. Participants will be required to participate in at least one resilience module activity per day and then they will have the choice to complete other activities with the digital companion. Some of the other activities participants can do with the digital companion include finding out information about mental health resources and COVID-19. Participants will give a minimum of 1 hour 45 minutes total time to the study over a one week period (at least 15 minutes of daily interaction plus completion of two 15-minute questionnaires). Participation will be completely remote and online, and participants will take part individually from their place of residence. Participants will be sent a daily text reminder to interact with the digital companion. Intervention adherence will be assessed by a self-reported daily use measure administered in the post-intervention questionnaire after one week of interaction.

The digital companion intervention can be accessed via the following URL: https://www.bellahelps.com
Intervention code [1] 317979 0
Treatment: Other
Intervention code [2] 317980 0
Behaviour
Comparator / control treatment
This study includes a waitlist control condition. Participants who are randomly allocated to the waitlist control group will wait one week (i.e. receive no treatment) before completing the same digital companion intervention as participants in the intervention group. All aspects of the intervention and its delivery will be the same as the intervention group, including intervention content, dose, duration, mode of administration, and location of participation.
Control group
Active

Outcomes
Primary outcome [1] 324322 0
Acceptability score as assessed by self-report measures designed for the study
Timepoint [1] 324322 0
7 days after intervention commencement
Primary outcome [2] 324323 0
Acceptability as assessed by self-reported intervention use in an online questionnaire (by a measure specifically designed for this study)
Timepoint [2] 324323 0
7 days after intervention commencement
Secondary outcome [1] 384315 0
Change in UCLA Loneliness score
Timepoint [1] 384315 0
Baseline, 7 days after intervention commencement
Secondary outcome [2] 384316 0
Relationship quality score as assessed by an adapted version of the McGill Friendship Questionnaire
Timepoint [2] 384316 0
7 days after intervention commencement
Secondary outcome [3] 384317 0
Change in COVID-19 related distress as measured by a 1-item scale developed for Jia et al. (2020)

Jia, R., Ayling, K., Chalder, T., Massey, A., Broadbent, E., Coupland, C., & Vedhara, K., (2020). Mental health in the UK during the COVID-19 pandemic: early observations. medRxiv. https://doi.org/10.1101/2020.05.14.20102012.
Timepoint [3] 384317 0
Baseline, 7 days after intervention commencement
Secondary outcome [4] 384318 0
Change in stress as measured by the 4-item Perceived Stress Scale
Timepoint [4] 384318 0
Baseline, 7 days after intervention commencement
Secondary outcome [5] 384319 0
Change in mood as measured by the Scale of Positive and Negative Experience
Timepoint [5] 384319 0
Baseline, 7 days after intervention commencement
Secondary outcome [6] 384355 0
Change in flourishing as measured by the Flourishing Scale
Timepoint [6] 384355 0
Baseline, 7 days after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria are adults aged 70 years or older, or adults aged 18 years or older with at least one of the following medical conditions: A serious respiratory disease (such as chronic lung disease or moderate to severe asthma), a serious heart condition, an immunocompromised condition (such as undergoing cancer treatment, smoking-related illness, bone marrow or organ transplantation, haematologic neoplasms, immune deficiency, uncontrolled HIV or AIDs, prolonged use of corticosteroids and/or other immune weakening medications such as disease-modifying anti-rheumatic drugs), a BMI of 40 or higher, diabetes, chronic kidney disease, undergoing dialysis, liver disease, and/or a pregnancy at the third trimester stage.
All participants must have English fluency and access to a computer and internet connection. Participants in the 70 years and older age group must not have cognitive decline.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are found to not have English fluency or they do not have access to a computer and/or internet connection. Participants in the 70 year old and above age group will be excluded if they have cognitive decline as indicated by a score of 24 or lower on the Mini Mental State Exam which will be administered as part of the eligibility screen.

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)
Participants will be randomly allocated into the intervention or waitlist control group by a researcher using Research Randomizer software. Group allocations will be concealed in sealed opaque envelopes.

Another researcher will conduct eligibility screens and enrol participants into the study over email. Participants in the 70 year old or above age group will have to do an in-person Mini Mental State Exam with a member of the research team as part of their eligibility screen. Once a participant has been enrolled into the study, provided written informed consent, and completed a baseline questionnaire online, the researcher will open the envelope to reveal which condition the participant has been allocated to and provide them with the appropriate instructions for proceeding in the trial over email (either, the participant will be provided with a link to begin the intervention, or they will be instructed they will be participating in the intervention in one weeks time, at which point they will be provided with a link to the intervention).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A waitlist control that receives the same intervention after completing a one-week wait period following enrolment in the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At least 30 participants will be recruited as a minimum of 12 participants per group is recommended for a feasibility study due to precision about the mean and variance (Julious, 2005), and allows for 20% attrition.

Data will be analysed using SPSS Version 26 software. Average acceptability and closeness scores will be calculated, and a series of t-tests will be conducted to compare changes in perceived loneliness, COVID-19 related distress, stress, mood and flourishing between the treatment and waitlist control groups. Qualitative data on intervention acceptability will be coded by two independent raters using conventional content analysis methods. Raters will derive a list of themes that represent the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2020
Actual
Date of last participant enrolment
Anticipated
12/10/2020
Actual
Date of last data collection
Anticipated
19/10/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 22707 0
New Zealand
State/province [1] 22707 0
Auckland
Country [2] 22708 0
New Zealand
State/province [2] 22708 0

Funding & Sponsors
Funding source category [1] 306108 0
University
Name [1] 306108 0
The University of Auckland
Country [1] 306108 0
New Zealand
Funding source category [2] 306109 0
Commercial sector/Industry
Name [2] 306109 0
Soul Machines Ltd
Country [2] 306109 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Psychological Medicine
The University of Auckland School of Medicine
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 306577 0
Commercial sector/Industry
Name [1] 306577 0
Soul Machines Ltd
Address [1] 306577 0
Soul Machines Ltd
106 Customs Street West
Auckland CBD
Auckland 1142
Country [1] 306577 0
New Zealand
Other collaborator category [1] 281377 0
Commercial sector/Industry
Name [1] 281377 0
Soul Machines Ltd
Address [1] 281377 0
Soul Machines Ltd
106 Customs Street West
Auckland CBD
Auckland 1142
Country [1] 281377 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306324 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 306324 0
Ethics committee country [1] 306324 0
New Zealand
Date submitted for ethics approval [1] 306324 0
19/05/2020
Approval date [1] 306324 0
06/07/2020
Ethics approval number [1] 306324 0
024752

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

Contacts
Principal investigator
Name 103510 0
Prof Elizabeth Broadbent
Address 103510 0
Department of Psychological Medicine
The University of Auckland School of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019, Auckland, 1142
Country 103510 0
New Zealand
Phone 103510 0
+6493737599
Fax 103510 0
Email 103510 0
[email protected]
Contact person for public queries
Name 103511 0
Elizabeth Broadbent
Address 103511 0
Department of Psychological Medicine
The University of Auckland School of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019, Auckland, 1142
Country 103511 0
New Zealand
Phone 103511 0
+6493737599
Fax 103511 0
Email 103511 0
[email protected]
Contact person for scientific queries
Name 103512 0
Elizabeth Broadbent
Address 103512 0
Department of Psychological Medicine
The University of Auckland School of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019, Auckland, 1142
Country 103512 0
New Zealand
Phone 103512 0
+6493737599
Fax 103512 0
Email 103512 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.