Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001121358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/08/2026
Date registered
Help: Date registered
9/09/2026
Date last updated
Help: Date last updated
9/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/09/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
An eight-week mindfulness and psychoeducation program to investigate metacognitive beliefs as a mechanism of effect on anxiety and depression symptoms in a general population.
Scientific title
An eight-week mindfulness and psychoeducation program to investigate metacognitive beliefs as a mechanism of effect on anxiety and depression symptoms in a general population.
Additional trial identifiers [1] 318087 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
anxiety 343148 0
depression 343149 0
Condition category
Condition code
Mental Health 339233 339233 0 0
Anxiety
Mental Health 339234 339234 0 0
Depression
Public Health 339465 339465 0 0
Health promotion/education
Public Health 339466 339466 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This was an intervention of eight 90-minute weekly sessions comprised of mindfulness training and psychoeducation on emotions, anxiety and depression. A certified trainer of the Cultivating Emotional Balance (CEB) program, on which this intervention was based, delivered it face-to-face, with more than fifteen years of experience teaching mindfulness and meditation.
It was delivered at the University of the Sunshine Coast, Sippy Downs campus, over 8 successive weekends.
Participants were allocated to different groups in the order they signed up for the study, making this a quasi-randomised trial.
Participants received workbooks to complete both in class with support and to journal their meditation practice and emotional reactivity between classes. The content of these journals was kept private, except for voluntary disclosure during in-class discussions.
Participants were asked to do 15 minutes of formal mindfulness practice per day, with the option of guided recordings or self-guided practice. Participants recorded the timing and comments about the session in a provided meditation tracking form.
Four of the eight sessions taught an appraisal model of emotions and provided support in developing plans to respond better under the influence of anger, sadness, fear, and enjoyable emotions. This content is based on the psychoeducational component of CEB, taken from the teacher training manual.
The other four sessions were mindfulness training, teaching basic theory and including 2x15-minute formal sessions. The content of this component was also taken from the CEB teacher training manual.
Attendance was monitored, as participants were required to attend 80% of the sessions.
Intervention code [1] 334987 0
Behaviour
Description of the comparator or control
A waitlist control group completed the same data collection measures within the same week as the experimental group. This was done face-to-face at the Engage Research Lab at the Sippy Downs campus of the University of the Sunshine Coast.
There were no requirements of this group beyond attending the three data collection sessions.
They were given access to an on-demand, online vesion of the same course material at the conclusion of the study.
Control group
Active

Outcomes
Primary outcome [1] 346466 0
Metacognitive beliefs
Timepoint [1] 346466 0
The primary timepoint was post-intervention, directly after the final session on week 8. Data was also collected at baseline (immediately before the first session), and mid point (after week 4 session).
Secondary outcome [1] 465947 0
Mindfulness
Timepoint [1] 465947 0
Baseline (before session 1), Midway ( after session 4), and post (after session 8)
Secondary outcome [2] 465948 0
Mindfulness
Timepoint [2] 465948 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [3] 465949 0
Mindfulness
Timepoint [3] 465949 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [4] 465950 0
Emotional recognition
Timepoint [4] 465950 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [5] 465951 0
Rumination (brooding)
Timepoint [5] 465951 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [6] 465952 0
Worry
Timepoint [6] 465952 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [7] 465953 0
Metacognitive beliefs
Timepoint [7] 465953 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [8] 465954 0
Anxiety
Timepoint [8] 465954 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [9] 465955 0
Depression
Timepoint [9] 465955 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [10] 467182 0
Rumination (reflective)
Timepoint [10] 467182 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [11] 467183 0
Mind-wandering: Deliberate
Timepoint [11] 467183 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)
Secondary outcome [12] 467184 0
Mind-wandering: Spontaneous
Timepoint [12] 467184 0
Baseline (before session 1), mid point (after session 4), post intervention (after session 8)

Eligibility
Key inclusion criteria
Fluent in English, Availble to attend 8 weekly sessions, and approximately 15 minutes of homework per day.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Sudden increase in anxiety or depression symptoms.

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/09/2022
Date of last participant enrolment
Anticipated
Actual
5/10/2022
Date of last data collection
Anticipated
Actual
27/11/2022
Sample size
Target
60
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 322645 0
University
Name [1] 322645 0
University of the Sunshine Coast
Country [1] 322645 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
Country
Australia
Secondary sponsor category [1] 325596 0
None
Name [1] 325596 0
Address [1] 325596 0
Country [1] 325596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321103 0
Human Research Ethics Committee of the University of the Sunshine Coast
Ethics committee address [1] 321103 0
Ethics committee country [1] 321103 0
Australia
Date submitted for ethics approval [1] 321103 0
04/03/2021
Approval date [1] 321103 0
19/05/2021
Ethics approval number [1] 321103 0
S201458

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

Contacts
Principal investigator
Name 152678 0
Prof Christian Jones
Address 152678 0
Engage Lab, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs QLD 4556
Country 152678 0
Australia
Phone 152678 0
+61 7 5459 4849
Fax 152678 0
Email 152678 0
[email protected]
Contact person for public queries
Name 152679 0
Dr Corey Jackson
Address 152679 0
Engage Lab, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs QLD 4556
Country 152679 0
Australia
Phone 152679 0
+61 466383767
Fax 152679 0
Email 152679 0
[email protected]
Contact person for scientific queries
Name 152680 0
Dr Corey Jackson
Address 152680 0
Engage Lab, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs QLD 4556231 Nolan St, Unanderra NSW 2526
Country 152680 0
Australia
Phone 152680 0
+61 466383767
Fax 152680 0
Email 152680 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participants were advised that their data would only be used by the current research team.



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.