Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000758505
Ethics application status
Approved
Date submitted
6/06/2024
Date registered
20/06/2024
Date last updated
18/08/2024
Date data sharing statement initially provided
20/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A blended brain training treatment for overthinking in students
Scientific title
Feasibility of a blended cognitive training intervention for overthinking in students
Secondary ID [1] 312298 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CoCA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 334035 0
anxiety 334036 0
Condition category
Condition code
Mental Health 330707 330707 0 0
Depression
Mental Health 330708 330708 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is called CoCA - Cognitive Control Training Aotearoa.

The digital aspects of the CoCA intervention have been recently developed by our study team at the Department of Psychological Medicine (UOC), in collaboration with University of Otago software design staff and independent sound engineers.

‘Blended’ refers to CoCA including therapist-guided and online/digital components. Participants will access an online interface which will deliver the online cognitive task. The specific training task is modelled on the adaptive Paced Auditory Serial Addition Task (aPASAT), a widely used task for cognitive control training interventions, found to be effective in reducing ruminative thinking and depression severity.

In the aPASAT, participants are presented with digits in a sequential fashion and asked to provide the sum of the 2 last heard digits (by selecting the correct sum on the screen). The aPASAT tailors the exercise based on individual performance by modifying the intertrial interval following every 4 consecutive correct (-100 milliseconds) or incorrect (+100 milliseconds) responses. Within the context of this task, individuals are continuously required to update information in working memory while preventing interference from previous responses.

An auditory distraction component, using a New Zealand-focused soundscape, has been incorporated into the end trial in the aPASAT to more specifically train executive functions of selective attention, mental flexibility, and inhibition. The soundscape plays four sounds, common in New Zealand, through headphones (New Zealand birds, circadas, a running stream, ticking clock and footsteps).

Participants will engage with the online cognitive task (described above) at least once per day for two weeks, at a maximum of twice per day (e.g., total of between 14 – 28 practice sessions). The task will take 8-12 minutes to complete. Participants will meet with a therapist (in-person or via Zoom) three times over the course of the 2-week intervention: 1) an intake session including consent, study information, and psychoeducation about rumination/over-thinking before the start of the intervention, 2) a ‘check-in’ session in the middle involving psychoeducation, supportive listening, and problem-solving, if needed, to increase engagement with online practices, and 3) close-out reflection session. Each session with the therapist will be 30-60 minutes.

The therapist will be a Research Assistant who has extensive experience working with mental health patients within clinical trials. She will be trained in supportive therapy techniques by KD (Clinical Psychologist) and supervised regularly (weekly 1:1 supervision sessions) over the course of the study. Training will occur over the course of 2 weeks, prior to study commencement, with 3 sessions of up to 2 hours. Training and supervision will continue over the course of the study, with weekly, 1 hour sessions.

Adherence to the intervention will be monitored via tracking responses to questions asked immediately after each cognitive training session, on the same app delivering the aPASAT. Participants will also be asked about the number of practices they have completed during the in-person therapist sessions.
Intervention code [1] 328766 0
Behaviour
Intervention code [2] 328815 0
Treatment: Other
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338462 0
Feasibility - recruitment rate and strategy
Timepoint [1] 338462 0
Assessed at the conclusion of the recruitment period.
Primary outcome [2] 338463 0
Feasibility - adherence to study protocol
Timepoint [2] 338463 0
Baseline to treatment-end (2 weeks after baseline) to follow-up (6 weeks after baseline)
Primary outcome [3] 338464 0
Feasibility - treatment acceptability and experience. This will be assessed as a composite outcome.
Timepoint [3] 338464 0
Treatment-end (2 weeks after baseline)
Secondary outcome [1] 436039 0
Rumination
Timepoint [1] 436039 0
Baseline, treatment-end (2 weeks after baseline)
Secondary outcome [2] 436040 0
Depression and anxiety. This will be assessed as a composite outcome.
Timepoint [2] 436040 0
Baseline, treatment-end (2 weeks after baseline)
Secondary outcome [3] 436041 0
Objective cognitive function
Timepoint [3] 436041 0
Baseline, treatment-end (2 weeks after baseline)
Secondary outcome [4] 436042 0
Subjective cognitive function
Timepoint [4] 436042 0
Baseline, treatment-end (2 weeks after baseline)

Eligibility
Key inclusion criteria
Current student at University of Otago, Christchurch campus or University of Canterbury, Christchurch campus
Aged between 18 and 65 years
Self-reporting high levels of rumination (> 50 on the Ruminative Responses Scale)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current suicidal ideation
bipolar disorder
psychotic disorder
neurological disease
current severe substance use disorder
unable to communicate in English
inability to engage with an online intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As well as primary feasibility outcomes above, we will examine effect size differences between baseline and treatment-end (2 weeks) on secondary outcomes. In previous similar intervention trials in remitted depressed participants (Belgium) and in currently depressed participants (USA), similar length cognitive control training interventions showed moderate (d = 0.51) and large (d = 1.4) effect size differences, respectively, in rumination scores from baseline to treatment end. The calculation of effect size on our measure of rumination (Ruminative Responses Scale), and other key outcomes measures (SCIP, DASS, CFQ), will allow us to compare with these previous studies and will provide information critical to a power calculation for a larger-scale RCT.

Qualitative analysis of post-treatment interviews will use thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
12/08/2025
Actual
Sample size
Target
20
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 26365 0
New Zealand
State/province [1] 26365 0
Canterbury

Funding & Sponsors
Funding source category [1] 316688 0
Government body
Name [1] 316688 0
Health Research Council of New Zealand
Country [1] 316688 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 318880 0
None
Name [1] 318880 0
Address [1] 318880 0
Country [1] 318880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315468 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 315468 0
Ethics committee country [1] 315468 0
New Zealand
Date submitted for ethics approval [1] 315468 0
06/06/2024
Approval date [1] 315468 0
12/07/2024
Ethics approval number [1] 315468 0
H24/0082

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

Contacts
Principal investigator
Name 134786 0
A/Prof Katie Douglas
Address 134786 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch
Country 134786 0
New Zealand
Phone 134786 0
+64 3 372 6739
Fax 134786 0
Email 134786 0
katie.douglas@otago.ac.nz
Contact person for public queries
Name 134787 0
Katie Douglas
Address 134787 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch
Country 134787 0
New Zealand
Phone 134787 0
+64 3 3726700
Fax 134787 0
Email 134787 0
katie.douglas@otago.ac.nz
Contact person for scientific queries
Name 134788 0
Katie Douglas
Address 134788 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch
Country 134788 0
New Zealand
Phone 134788 0
+64 3 3726700
Fax 134788 0
Email 134788 0
katie.douglas@otago.ac.nz

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.