Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000061336
Ethics application status
Approved
Date submitted
15/12/2016
Date registered
11/01/2017
Date last updated
25/09/2019
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Mindfulness-integrated cognitive behaviour therapy for reducing symptoms of depression, anxiety and stress in patients with common mental health conditions: a randomised controlled trial
Scientific title
Effectiveness of mindfulness-integrated cognitive behaviour therapy (MiCBT) compared to a wait-list control for reducing symptoms of depression, anxiety and stress in patients with common mental health conditions over a six month follow-up: a randomised controlled trial
Secondary ID [1] 290623 0
None
Universal Trial Number (UTN)
U1111-1190-8640
Trial acronym
MiCBT Trial
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Mental Health Condition 301129 0
Stress 301428 0
Depression 301429 0
Anxiety 301430 0
Condition category
Condition code
Mental Health 300895 300895 0 0
Depression
Mental Health 300896 300896 0 0
Anxiety
Mental Health 300897 300897 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research explores MiCBT in a group intervention format comprising weekly two-hour sessions for 8 weeks. The program is based on the published protocol described in "Mindfulness-Integrated CBT, Principles and Practice", Cayoun, 2011 and is delivered by one psychologist to groups of 10-15 participants. The intervention is administered in a psychology clinic. Attendance of participants at each session will be recorded and non-attenders will be followed up. MiCBT integrates aspects of cognitive behaviour therapy with the teaching of mindfulness skills. The mindfulness exercises in the program focus strongly on body scanning techniques requiring daily practice exercises throughout the program. Stage 1 of the program develops self-awareness, attention regulation, metacognitive and interoceptive awareness and response inhibition. Stages 2, 3, and 4, focus on exposure techniques, the application of skills to external and interpersonal contexts and managing avoidance. The impact of ethical and compassionate behaviour is addressed in stage 4. The development of interoceptive awareness with equanimity is considered to be a key aspect of the therapeutic process.
Intervention code [1] 296496 0
Behaviour
Intervention code [2] 296716 0
Treatment: Other
Comparator / control treatment
Wait-list control - will be offered the program after the 6 month follow up with the MiCBT experimental group.
Control group
Active

Outcomes
Primary outcome [1] 300301 0
Change in clinical symptoms measured by the Depression, Anxiety and Stress Scale (DASS 21)
Timepoint [1] 300301 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up. The primary endpoint is 6 months post treatment.
Update

An additional post-intervention data collection point will occur for control group participants who choose to participate in the MiCBT 8 week program following completion of the 6-month data collection. This makes the project more in line with a stepped-wedge design.
Primary outcome [2] 300381 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up. The primary endpoint is 6 months post-treatment.
Update

An additional post-intervention data collection point will occur for control group participants who choose to participate in the MiCBT 8 week program following completion of the 6-month data collection. This makes the project more in line with a stepped-wedge design.
Timepoint [2] 300381 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up. The primary endpoint is 6 months post treatment.
Update

An additional post-intervention data collection point will occur for control group participants who choose to participate in the MiCBT 8 week program following completion of the 6-month data collection. This makes the project more in line with a stepped-wedge design.
Secondary outcome [1] 329651 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up. The primary endpoint is 6 months post treatment.
Update

An additional post-intervention data collection point will occur for control group participants who choose to participate in the MiCBT 8 week program following completion of the 6-month data collection. This makes the project more in line with a stepped-wedge design.
Timepoint [1] 329651 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up. The primary endpoint is 6 months post-treatment.
Update

An additional post-intervention data collection point will occur for control group participants who choose to participate in the MiCBT 8 week program following completion of the 6-month data collection. This makes the project more in line with a stepped-wedge design.
Secondary outcome [2] 330218 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up. The primary endpoint is 6 months post treatment.
Update

An additional post-intervention data collection point will occur for control group participants who choose to participate in the MiCBT 8 week program following completion of the 6-month data collection. This makes the project more in line with a stepped-wedge design.
Timepoint [2] 330218 0
Measurement will occur at baseline, mid-intervention, post-intervention, and at 6 months follow up.
Secondary outcome [3] 330315 0
Change in metacognitive awareness measured by the Experiences Questionnaire (EQ)
Timepoint [3] 330315 0
Baseline, mid-intervention, post-intervention and at 6 months follow up
Secondary outcome [4] 330316 0
Change in interoceptive awareness measured by the Multi-dimensional Assessment of Interoceptive Awareness (MIAI)
Timepoint [4] 330316 0
Baseline, mid-intervention, post-intervention and at 6 months follow up
Secondary outcome [5] 330317 0
Change in non- attachment and equanimity measured by the Non-attachments Scale (NAS)
Timepoint [5] 330317 0
Baseline, mid-intervention, post-intervention and at 6 months follow up
Secondary outcome [6] 330318 0
Change in emotion Regulation and Distress Tolerance measured by the appropriate sub-scales of MSES-R
Timepoint [6] 330318 0
Baseline, mid-intervention, post-intervention and at 6 months follow up
Secondary outcome [7] 330319 0
Change in interpersonal effectiveness, taking responsibility and social skills measured by appropriate sub-scales of the MSES-R
Timepoint [7] 330319 0
Baseline, mid-intervention, post-intervention and at 6 months follow up

Eligibility
Key inclusion criteria
K10 score greater than or equal to 20
Referral from medical practitioner
Fluent in English
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years of age, non-English speakers, current psychotic symptoms, current borderline or antisocial personality disorder, and current drug or alcohol dependency, pervasive developmental delay, organic mental disorder.

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)
Central randomisation by an independent researcher using computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to treatment conditions will be done by an independent researcher using a minimisation routine balancing numbers in groups as randomisation proceeds. To guard against confounding by major differences in baseline severity, other treatment exposures and to support subgroup analyses, randomisation will be stratified by K10 scores (mild-moderate K10 score of less than or equal to 30 vs, severe K10 score greater than or equal to 30), levels of psychological distress), antidepressant or mood stabilizer medication (yes/no) and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using G-power 3.1. Based on a sample size of 102 completers (51 participants in each group) and a recruitment target of 120 (assuming a 15% drop-out rate), the trial is powered to detect a medium effect (Cohen’s d = .5), using the conventional significance level, (.05), and power of .08.

Statistical analysis will be conducted using SPSS statistical software package. The dependent variables are scores on the DASS-21, K10, SWLS and the FS. Mediation variables include the Experiences Questionnaire (EQ), the Mindfulness-based self-efficacy scale (MSES-R), Multi-dimensional Assessment of Interoceptive Awareness (MAIA), and the Non-attachment Scale (NAS). It is expected that the MiCBT group will show significantly improved scores as compared to the treatment as usual control group across the DASS-21 (lower scores), the K10 (lower scores) the MSES-R (higher scores), the MAIA (higher scores), the EQ (higher scores), the SWLS (higher scores), FS (higher scores) and the NAS (higher scores).

The differential changes in the MiCBT group compared to the control group is the primary focus of the analysis. Analysis will use mixed-model repeated measures (MMRM) the method recommended for clinical trial data. Evidence for the efficacy of MiCBT will be demonstrated by a significant two-way interaction demonstrating greater change in the outcome measures in the MiCBT group from the control group pre to post intervention. Baseline to follow-up interactions for the MiCBT group will also be examined and changes compared with post intervention data.

Intention-to-treat (ITT) analysis will be used because this approach uses all available information. Subjects with incomplete data are not discarded and missing data are not replaced with estimated values. This is consistent with the CONSORT standard (Turner et al, 2011). If data are grossly non-normal and cannot be successfully transformed, then it will be analysed using non-parametric methods.

The mediational impact of pre to post MAIA, MSES, EQ and NAS will be assessed using the Sobel test, a powerful method for measuring indirect effects (Sobel, 1982). The test assesses the significance of the product of the coefficients for treatment-mediator and mediator-outcome effects. A bootstrapped multivariate extension of the Sobel test will be used to examine both the total indirect effect and the individual effect of each mediator.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2017
Actual
31/07/2017
Date of last participant enrolment
Anticipated
Actual
10/10/2018
Date of last data collection
Anticipated
5/06/2019
Actual
11/08/2019
Sample size
Target
120
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295058 0
University
Name [1] 295058 0
Monash University
Country [1] 295058 0
Australia
Primary sponsor type
Individual
Name
Dr Frances Shawyer,
Address
Monash Medicine, Nursing and Health Sciences
Southern Synergy
Administration, Research & Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country
Australia
Secondary sponsor category [1] 293873 0
Individual
Name [1] 293873 0
Dr. Bruno Cayoun
Address [1] 293873 0
MiCBT Institute
277 Macquarie St,
Hobart
TASMANIA 7000
Country [1] 293873 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296404 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 296404 0
Ethics committee country [1] 296404 0
Australia
Date submitted for ethics approval [1] 296404 0
06/07/2016
Approval date [1] 296404 0
19/09/2016
Ethics approval number [1] 296404 0
CF16/2278-2016001131

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

Contacts
Principal investigator
Name 70762 0
Dr Frances Shawyer
Address 70762 0
Administration, Research and Training (ART) Building
Adult Mental Health
Dandenong Hospital
126 - 128 Cleeland St
Dandenong Vic 3175
Country 70762 0
Australia
Phone 70762 0
+61 3 9902 9461
Fax 70762 0
+61 3 9902 9900
Email 70762 0
[email protected]
Contact person for public queries
Name 70763 0
Sarah Francis
Address 70763 0
Melbourne Mindfulness Institute
314/530 Little Collins Street
Melbourne
Victoria, 3000
Country 70763 0
Australia
Phone 70763 0
+61 409669688
Fax 70763 0
+61 370005017
Email 70763 0
[email protected]
Contact person for scientific queries
Name 70764 0
Sarah Francis
Address 70764 0
Melbourne Mindfulness Institute
314/530 Little Collins Street
Melbourne
Victoria, 3000
Country 70764 0
Australia
Phone 70764 0
+61 409669688
Fax 70764 0
+61 370005017
Email 70764 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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a randomized control trial to investigate the effectiveness of an 8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention for primary care patients.2020https://dx.doi.org/10.1186/s12888-019-2411-1
EmbaseGroup Mindfulness-Integrated Cognitive Behavior Therapy (MiCBT) Reduces Depression and Anxiety and Improves Flourishing in a Transdiagnostic Primary Care Sample Compared to Treatment-as-Usual: A Randomized Controlled Trial.2022https://dx.doi.org/10.3389/fpsyt.2022.815170
N.B. These documents automatically identified may not have been verified by the study sponsor.