Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000711314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/05/2026
Date registered
Help: Date registered
15/06/2026
Date last updated
Help: Date last updated
15/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/06/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing a Cognitive Bias Modification Intervention for Informal Caregivers of People With Dementia
Scientific title
Preliminary Effects of Cognitive Bias Modification for Interpretation Among Informal Caregivers of People With Dementia: A Proof-of-Concept Randomized Controlled Trial
Additional trial identifiers [1] 317422 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 342090 0
Anxiety 342091 0
Stress 342093 0
Condition category
Condition code
Mental Health 338211 338211 0 0
Depression
Mental Health 338212 338212 0 0
Anxiety
Mental Health 338359 338359 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention is Cognitive Bias Modification for interpretation (CBM-I) a web based digital intervention. Training items follow the traditional CBM format (i.e., three short sentences depicting everyday ambiguous events), and the final word to allow missing letters. This creates a word task for participants to resolve, which is designed to encourage a positive interpretation of the scenarios in each CBM-I training item. CBM-I included 100 training items. CBM-I training delivered via Qualtrics, an online survey platform, and participants will complete the study remotely on their own devices at home individually. This is a 1.5 hour single session intervention. The content of the intervention related to the everyday ambiguous situations that informal caregivers experience daily basis. The intervention train participants to interpret these situations in positive way by the word task presented. For example "You help your loved one through their daily routine. They start to yell at you. You think you are doing your…" Then the word presented with "b-st". They have to fill the word.
Usually in Qualtrics software provide all the data on number of participants completed the intervention and how long they have taken. Therefore, adherence will calculated by the number participants who completed the study.
Intervention code [1] 334216 0
Treatment: Other
Intervention code [2] 334298 0
Behaviour
Description of the comparator or control
The items in the control group presented with exactly the same as the CBM-I training items except that the control scenarios included are trivial items (e.g., non-ambiguous, factual information). Example; "Tigers are known for their strength and stealth. They can be found in Asia in countries like Thailand, India, and Indonesia. They have black stripes on their…b-dy (body)].
participants will not be gain access to CBM-I intervention.
Control group
Active

Outcomes
Primary outcome [1] 345575 0
Interpretation Bias
Timepoint [1] 345575 0
Baseline and after the CBM-I intervention
Secondary outcome [1] 462215 0
Depression
Timepoint [1] 462215 0
After the CBM-I intervention
Secondary outcome [2] 462219 0
Stress
Timepoint [2] 462219 0
At the end of the CBM-I intervention
Secondary outcome [3] 462220 0
Anxiety
Timepoint [3] 462220 0
At the end of the intervention
Secondary outcome [4] 462221 0
Caregiver burden
Timepoint [4] 462221 0
Baseline and at the end of the intervention
Secondary outcome [5] 462224 0
Cognitive characteristics of Depression
Timepoint [5] 462224 0
At the end of the CBM-I intervention
Secondary outcome [6] 462227 0
State Mindfulness
Timepoint [6] 462227 0
Baseline and at the end of the CBM-I intervention
Secondary outcome [7] 462228 0
Trait Mindfulness
Timepoint [7] 462228 0
At the end of the CBM-I intervention

Eligibility
Key inclusion criteria
18 years and older
Provide care for a person with dementia
Is voluntarily caring for the person and is a family member or a friend
Devotes at least 1 hour per day for each day of the week OR a total of 7 hours per week, sustained over a period of 3 months
Is fluent in English
Is not currently working as professional caregivers elsewhere.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
If they are working as professional caregivers elsewhere.
Currently under any other psychotherapy

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed
Allocation done by the Qualtrics randomization in built software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
participants randomized to either the CBM-I intervention group or the control group through Qualtrics’ randomizer function using simple randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
t- tests to test the mean differences and two way repeated measures ANOVA
Correlation and mediation analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/01/2026
Date of last participant enrolment
Anticipated
6/07/2026
Actual
Date of last data collection
Anticipated
6/07/2026
Actual
Sample size
Target
60
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 28161 0
New Zealand
State/province [1] 28161 0
Otago

Funding & Sponsors
Funding source category [1] 321996 0
University
Name [1] 321996 0
PhD Fund - University of Otago
Country [1] 321996 0
New Zealand
Primary sponsor type
Individual
Name
Jerry Hsu - University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 324872 0
None
Name [1] 324872 0
Address [1] 324872 0
Country [1] 324872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320530 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 320530 0
Ethics committee country [1] 320530 0
New Zealand
Date submitted for ethics approval [1] 320530 0
17/06/2025
Approval date [1] 320530 0
10/07/2025
Ethics approval number [1] 320530 0

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

Contacts
Principal investigator
Name 150770 0
Dr Jerry Hsu
Address 150770 0
Department of Psychological Medicine, 464 Cumberland Street Dunedin 9016 New Zealand
Country 150770 0
New Zealand
Phone 150770 0
+64223752741
Fax 150770 0
Email 150770 0
[email protected]
Contact person for public queries
Name 150771 0
Oshadhi Manathungage
Address 150771 0
Department of Psychological Medicine, 464 Cumberland Street Dunedin 9016 New Zealand
Country 150771 0
New Zealand
Phone 150771 0
+64274731907
Fax 150771 0
Email 150771 0
[email protected]
Contact person for scientific queries
Name 150772 0
Oshadhi Manathungage
Address 150772 0
Department of Psychological Medicine, 464 Cumberland Street, Dunedin 9016, New Zealand
Country 150772 0
New Zealand
Phone 150772 0
+64274731907
Fax 150772 0
Email 150772 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.