Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000680965
Ethics application status
Approved
Date submitted
8/05/2020
Date registered
15/06/2020
Date last updated
21/10/2021
Date data sharing statement initially provided
15/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a cognitive bias modification of interpretations on anxiety and depressive symptoms in adults
Scientific title
Effect of a cognitive bias modification of interpretations on anxiety and depressive symptoms in adults
Secondary ID [1] 301228 0
None
Universal Trial Number (UTN)
U1111-1251-7298
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 317394 0
Depression 317395 0
Condition category
Condition code
Mental Health 315497 315497 0 0
Anxiety
Mental Health 315498 315498 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study investigates the effectiveness and acceptability of a modified cognitive bias modification of interpretation (CBM-I) training program for adults with high levels of symptoms of both anxiety and depression. Individuals will be randomly allocated to either a training or control condition.
The training condition involves modifying biases associated with both anxiety and depression. Specifically, individuals will be trained to interpret ambiguous information more positively and to attribute positive outcomes to themselves. The single session program will be delivered via internet, on a home computer, laptop or iPad, to participants (usually at home), in the presence of the researcher via Zoom. The Zoom session duration is approximately 1 hour and 15 minutes. There are no further resources/ materials used in the delivery of the training program.
The researcher is a student researcher who volunteered with various organisations in the mental health and support sphere and is able to support participants if they become distressed during or after assessment.

Intervention code [1] 317535 0
Behaviour
Intervention code [2] 317642 0
Treatment: Other
Comparator / control treatment
The training will be compared to a control condition in which sham training is provided (i.e. does not train individuals). Sham training is carried out in the same way as the training (i.e., on a computer or laptop or iPad at home, via the internet, with this researcher present via Zoom. The sham program consists of scenarios without ambiguity or emotional valence, and comprehension questions relate to generic details, such as colour or type. The sham program, along with the same questionnaires as for the training program, takes approximately one hour to complete.
Control group
Placebo

Outcomes
Primary outcome [1] 323740 0
Interpretation bias scores will be measured on the Interpretation Bias Task (IBT) measure, at pre-training, post-training, and 1-week follow-up.
Timepoint [1] 323740 0
Pre training (immediately prior to training session), post training (immediately after training session) and 1-week follow-up. Primary time-point is post-training measurement.
Primary outcome [2] 323741 0
Attribution style scores will be measured on the Attribution Style Questionnaire (ASQ) measure, at pre-training, post-training, and 1-week follow-up.
Timepoint [2] 323741 0
Pre training (immediately prior to training session), post training (immediately after training session) and 1-week follow-up. Primary time-point is post-training measurement.
Secondary outcome [1] 382766 0
Depression, anxiety and stress scores will be measured on the DASS-21 at pre-training (immediately prior to training session) and 1-week follow-up.
Timepoint [1] 382766 0
Pre training (immediately prior to training session), 1-week follow-up.
Secondary outcome [2] 382767 0
Depression and tension scores will be measured on the POMS-SF depression and tension sub-scales at pre-training (immediately prior to training session) and post-training (immediately after training session).
Timepoint [2] 382767 0
Pre training (immediately prior to training session), post training (immediately after training session).
Secondary outcome [3] 382768 0
Score on Acceptability of Treatment Scale (ATS) will be measured.
Timepoint [3] 382768 0
1-week follow-up

Eligibility
Key inclusion criteria
Prior to taking part in the study, individuals will be screened for elevated levels of anxiety and depression symptoms. This is because the study involves training to reduce anxiety and depression symptoms and screening will reduce the likelihood of a floor effect of the training. Only participants who self-report as having mild (or above) levels of anxiety and depressive symptoms using a validated self-report questionnaire of anxiety and depression symptoms (Kessler Psychological Distress Scale K10] (Kessler et al., 2003)) will be invited to take part. Only individuals who meet this eligibility criteria, who are aged 18 years and above and fluent in English will be invited to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those in current treatment for an anxiety- or depression- related mental health condition.

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)
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was carried out using G-Power. We anticipated a medium effect based on the literature and used the following values: .80 power, alpha of .05.
With three measurement points, a total sample size of 42 (21 in each of the two conditions) was indicated. To allow for anticipated drop-out and to garner participants currently experiencing at least mild levels of depression and anxiety, a sample size of 37 in each condition is targeted.
A mixed factorial design will compare means for each outcome measure by group and time. Analysis of variance (ANOVA) will be used to analyse data. Correlation analysis will also be used to compare rates of change between the outcome measures.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment has been completed early, due to research deadline requirements (Honours thesis) and sufficient non-excluded participants.
Date of first participant enrolment
Anticipated
Actual
24/04/2020
Date of last participant enrolment
Anticipated
15/08/2020
Actual
10/08/2020
Date of last data collection
Anticipated
15/08/2020
Actual
10/08/2020
Sample size
Target
74
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305679 0
University
Name [1] 305679 0
Macquarie University
Country [1] 305679 0
Australia
Primary sponsor type
Individual
Name
Dr Gemma Sicouri
Address
Macquarie University
Ryde, NSW2109
Country
Australia
Secondary sponsor category [1] 306088 0
Individual
Name [1] 306088 0
Janine Rogers
Address [1] 306088 0
Macquarie University
Ryde, NSW2109
Country [1] 306088 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305959 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 305959 0
Ethics committee country [1] 305959 0
Australia
Date submitted for ethics approval [1] 305959 0
09/02/2020
Approval date [1] 305959 0
19/03/2020
Ethics approval number [1] 305959 0

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

Contacts
Principal investigator
Name 102214 0
Dr Gemma Sicouri
Address 102214 0
Macquarie University
Ryde, NSW2109
Country 102214 0
Australia
Phone 102214 0
+61 298508714
Fax 102214 0
Email 102214 0
[email protected]
Contact person for public queries
Name 102215 0
Janine Rogers
Address 102215 0
Macquarie University
Ryde, NSW2109
Country 102215 0
Australia
Phone 102215 0
+61 2 9850 7111
Fax 102215 0
Email 102215 0
[email protected]
Contact person for scientific queries
Name 102216 0
Janine Rogers
Address 102216 0
Macquarie University
Ryde, NSW2109
Country 102216 0
Australia
Phone 102216 0
+61 410541785
Fax 102216 0
Email 102216 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.