Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12622000722796
Ethics application status
Approved
Date submitted
18/04/2022
Date registered
19/05/2022
Date last updated
14/06/2023
Date data sharing statement initially provided
19/05/2022
Date results information initially provided
14/06/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
A Social Humanoid Robot to Deliver Cognitive Flexibility Training for Healthy Adults
Query!
Scientific title
An Investigation of Feasibility for A Social Humanoid Robot to Deliver Emotion Regulation Training and its Effect on Cognitive Flexibility in Healthy Adults
Query!
Secondary ID [1]
306877
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cognitive Flexibility
325779
0
Query!
Condition category
Condition code
Mental Health
323118
323118
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Depression and anxiety symptoms often are exacerbated by unhelpful thoughts and beliefs. Identifying unhelpful, automatic thoughts and instead holding alternate thoughts can be termed cognitive flexibility.
This trial is a single-arm, pilot project to evaluate whether a humanoid social robot can deliver a digitised version of an intervention that can help to teach people skills related to cognitive flexibility, and to improve their use of cognitive flexibility on completion of the session. This trial aims to evaluate the feasibility, preliminary effectiveness, and delivery method of a novel robot-delivered intervention.
The use of a humanoid social robot offers a new delivery mechanism for well-established cognitive flexibility interventions. Potential significance includes the capacity to help young adults to improve cognitive flexibility with the secondary aim to potentially reduce the prevalence of thought patterns that can lead to symptoms of depression and anxiety. The novel robot delivery method may assist with scaling and with people who are uncomfortable seeking support from a counsellor or psychologist.
Participants will complete online questionnaires at Baseline and Post-Intervention (2-weeks), and complete a 45-minute intervention session led by the Pepper robot, which will deliver an adapted version of a psychotherapeutic treatment related to cognitive flexibility through the Pepper robot, which is based on Cognitive Behavioural Therapy. This intervention will be delivered both as an in-person test, as well as remote/online as an alterative to those who are unable to attend the in-person session. Participants will engage with the intervention by progressing through the content steps provided during the session.
Query!
Intervention code [1]
323215
0
Behaviour
Query!
Intervention code [2]
323596
0
Treatment: Other
Query!
Comparator / control treatment
There is no comparator or control treatment.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
330886
0
A primary outcome is to determine the impact on specific types of unhelpful, inflexible thoughts such as catastrophizing. Selected subscales from the Cognitive Emotion Regulation Questionnaire (CERQ) will be used to measure specific types of unhelpful, inflexible thoughts.
Query!
Assessment method [1]
330886
0
Query!
Timepoint [1]
330886
0
Baseline, post-intervention (2-weeks).
Query!
Secondary outcome [1]
407923
0
A secondary outcome is to determine the effect on overall emotion regulation difficulty in participants from baseline to post intervention. Difficulties in Emotion Regulation Scale (DERS) is a published validated measure of overall emotion regulation difficulty.
Query!
Assessment method [1]
407923
0
Query!
Timepoint [1]
407923
0
Baseline, post-intervention (2-weeks).
Query!
Secondary outcome [2]
407924
0
A secondary outcome is to determine if cognitive flexibility changes in participants from baseline to post intervention. A secondary outcome will be measured by capturing changes on the UP Cognitive Skills Questionnaire (UPCSQ). The UPCSQ is a published validated measure of cognitive skills, including to assess cognitive flexibility.
Query!
Assessment method [2]
407924
0
Query!
Timepoint [2]
407924
0
Baseline, post-intervention (2-weeks).
Query!
Secondary outcome [3]
408801
0
A secondary outcome is to determine if depression symptoms change from baseline to post intervention. A secondary outcome will be measured by capturing changes on depression symptoms from the PROMIS Depression CATs, which is a published and validated symptom measure.
Query!
Assessment method [3]
408801
0
Query!
Timepoint [3]
408801
0
Baseline, post-intervention (2-weeks).
Query!
Secondary outcome [4]
409686
0
A secondary outcome is to determine if anxiety symptoms change from baseline to post intervention. A secondary outcome will be measured by capturing changes on anxiety symptoms from the PROMIS Anxiety CATs, which is a published and validated symptom measure.
Query!
Assessment method [4]
409686
0
Query!
Timepoint [4]
409686
0
Baseline, post-intervention (2-weeks).
Query!
Eligibility
Key inclusion criteria
At least 18 years of age or older and currently enrolled as a university student.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Participants will be excluded from the study if they: (a) are not a Monash university student, (b) have severe depression or anxiety symptoms (T Scores equal to 70 on the Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS Depression CAT or PROMIS Anxiety CAT, and (c) are under 18 years old.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Demographics and feasibility will be assessed using descriptive statistics. One sample T Tests will be used to assess change scores from baseline to post-intervention.
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Data collected is being analysed
Query!
Reason for early stopping/withdrawal
Participant recruitment difficulties
Query!
Date of first participant enrolment
Anticipated
30/05/2022
Query!
Actual
10/08/2022
Query!
Date of last participant enrolment
Anticipated
25/10/2022
Query!
Actual
14/02/2023
Query!
Date of last data collection
Anticipated
25/11/2022
Query!
Actual
28/02/2023
Query!
Sample size
Target
50
Query!
Accrual to date
Query!
Final
27
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
311106
0
University
Query!
Name [1]
311106
0
Monash University
Query!
Address [1]
311106
0
18 Alliance Lane, Clayton, Victoria, 3800
Query!
Country [1]
311106
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Monash University
Query!
Address
18 Alliance Lane, Clayton, Victoria, 3800
Query!
Country
Australia
Query!
Secondary sponsor category [1]
312437
0
None
Query!
Name [1]
312437
0
Query!
Address [1]
312437
0
Query!
Country [1]
312437
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
310636
0
Monash University Human Research Ethics Committee
Query!
Ethics committee address [1]
310636
0
18 Alliance Lane, Clayton, Victoria, 3800
Query!
Ethics committee country [1]
310636
0
Australia
Query!
Date submitted for ethics approval [1]
310636
0
29/06/2021
Query!
Approval date [1]
310636
0
10/08/2021
Query!
Ethics approval number [1]
310636
0
26268
Query!
Summary
Brief summary
This trial will investigate the use of a social humanoid robot to deliver a novel cognitive flexibility intervention designed to help people to use flexible thinking patterns to overcome cognitive biases or distortions. It is intended that this trial will support university students by teaching them new techniques to help overcome thinking traps and how to better deal with negative automatic thoughts.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
118346
0
Dr Nicole Robinson
Query!
Address
118346
0
Monash University, 18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Query!
Country
118346
0
Australia
Query!
Phone
118346
0
+61 0399058933
Query!
Fax
118346
0
Query!
Email
118346
0
[email protected]
Query!
Contact person for public queries
Name
118347
0
Dr Nicole Robinson
Query!
Address
118347
0
Monash University, 18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Query!
Country
118347
0
Australia
Query!
Phone
118347
0
+61 0399058933
Query!
Fax
118347
0
Query!
Email
118347
0
[email protected]
Query!
Contact person for scientific queries
Name
118348
0
Dr Nicole Robinson
Query!
Address
118348
0
Monash University, 18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Query!
Country
118348
0
Australia
Query!
Phone
118348
0
+61 0399058933
Query!
Fax
118348
0
Query!
Email
118348
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF