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Trial registered on ANZCTR


Registration number
ACTRN12621000960853
Ethics application status
Approved
Date submitted
1/06/2021
Date registered
23/07/2021
Date last updated
23/03/2023
Date data sharing statement initially provided
23/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Mindfulness Based Intervention for Adults with Cerebral Palsy with Anxiety and/or Emotion Regulation Difficulties
Scientific title
A study to investigate the effect of a mindfulness based intervention for adults with cerebral palsy with anxiety and/or emotion regulation difficulties, on mindfulness knowledge and practice.
Secondary ID [1] 304374 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 322163 0
anxiety 322164 0
emotion dysregulation 322167 0
Condition category
Condition code
Mental Health 320311 320311 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Mindfulness Based Stress Reduction (MBSR) and waitlist control
Mode of delivery: MBSR group sessions will occur through TEAMS (teleconferencing software) and will be approximately 1.5 hours long.
The MBSR program will run over 9 sessions (weekly for 9 weeks) each being 1.5 hours long. Additionally participants will also have homework activities that they will be asked to work on between sessions. The social worker leading the group will guide them through each mindfulness session which will have a specific area of focus.
These are:
Session 1: Course overview and What is Mindfulness?
Session 2: The mind-body connection – how our body responds physiologically to anxiety and stress.
Session 3: How to practice mindfulness meditation
Session 4: How mindfulness works with anxiety and stress
Session 5: Mindfulness for the body
Session 6: Deepening your practice – sitting meditation
Session 7: Meditation for anxiety and stress
Session 8: Loving kindness meditation
Session 9: Interpersonal mindfulness and how to make mindfulness part of your everyday life

Participants will access the MBSR program via TEAMS, most likely at their place of residence.
In order to monitor adherence to the intervention a session attendance checklist will be completed each week by the social worker leading the group.
Intervention code [1] 320741 0
Treatment: Other
Comparator / control treatment
Waitlist control
The waitlist control group will be offered the intervention 8 weeks after the 9 week intervention period.
The control group will receive no interventions during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 327729 0
The primary outcome measure is the mean between group difference in Cognitive and Affective Mindfulness Scale-R (CAMS-R) total scores from T1 to T2.
Timepoint [1] 327729 0
Baseline T1 and completion of MBSR intervention T2
Secondary outcome [1] 396371 0
The mean between group difference in Cognitive and Affective Mindfulness Scale-R scores from T1 to T3
Timepoint [1] 396371 0
Baseline (T1) and 8 weeks post completion of intervention (T3)
Secondary outcome [2] 396372 0
The mean within group difference in the Cognitive and Affective Mindfulness Scale-R total score from T1 to T2 and T1 to T3 for the MBSR intervention group.
Timepoint [2] 396372 0
Baseline (T1) , on completion of MBSR intervention (T2) and 8 weeks after completion of intervention (T3)
Secondary outcome [3] 396374 0
Depression assessed using Depression Anxiety and Stress Scale – 21 (DASS-21), mean within group difference from T1 to T2 and T1 to T3



Timepoint [3] 396374 0
Baseline (T1) , on completion of MBSR intervention (T2 ) and eight weeks post-intervention (T3)
Secondary outcome [4] 397893 0
Anxiety assessed using Depression Anxiety and Stress Scale – 21 (DASS-21), mean within group difference from T1 to T2 and T1 to T3
Timepoint [4] 397893 0
Baseline (T1) , on completion of MBSR intervention (T2 ) and eight weeks post-intervention (T3)
Secondary outcome [5] 397894 0
Stress assessed using Depression Anxiety and Stress Scale – 21 (DASS-21), mean within group difference from T1 to T2 and T1 to T3
Timepoint [5] 397894 0
Baseline (T1) , on completion of MBSR intervention (T2 ) and eight weeks post-intervention (T3)
Secondary outcome [6] 397895 0
Emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) mean within group difference from T1 to T2 and T1 to T3
Timepoint [6] 397895 0
Baseline (T1) , on completion of MBSR intervention (T2 ) and eight weeks post-intervention (T3)
Secondary outcome [7] 397896 0
Pain intensity using the Brief Pain Inventory (BPI) Short Form mean within group difference from T1 to T2 and T1 to T3
Timepoint [7] 397896 0
Baseline (T1) , on completion of MBSR intervention (T2 ) and eight weeks post-intervention (T3)
Secondary outcome [8] 397897 0
Pain interference using the Brief Pain Inventory (BPI) Short Form mean within group difference from T1 to T2 and T1 to T3
Timepoint [8] 397897 0
Baseline (T1) , on completion of MBSR intervention (T2 ) and eight weeks post-intervention (T3)
Secondary outcome [9] 397898 0
Level of anxiety using a 10 point Likert scale for 5 individually identified anxiety inducing situations, point changes between T1 and T3
Timepoint [9] 397898 0
Baseline (T1) and eight weeks post-intervention (T3)

Eligibility
Key inclusion criteria
Adult with CP
Aged 20-40 years of age
English speaker/communicator
Identify as having elevated anxiety or emotional regulation difficulties; and obtain one or more of the following scores on baseline assessment:
Mild to extremely severe score on the Anxiety subscale of the (Depression, Anxiety, Stress Scale-21) DASS-21
Difficulties in Emotion Regulation Scale (DERS) total raw score of 99 or higher
No reported moderate to severe intellectual impairment
Identify as having functional hearing and vision
Has not participated in active mindfulness training in the past 12-months.
Has access to Internet, laptop or personal computer for access to TEAMS and have a web camera and microphone (standard on most laptops/personal computers).
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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 computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified by ambulant /non-ambulant ability using block randomization of 4, to ensure equal spread of ambulance level across treatment/wait list control groups. The Gross Motor Function Classification System (GMFCS) will be used to categorize participants as ambulant (GMFCS levels I and II) or non-ambulant (GMFCS levels III-V).

Allocation using this method will be completed using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Adults with CP with anxiety and/or emotion regulation difficulties minimum n=30.
This study aims to detect a large effect size equivalent to Cohen’s d = 0.8 in the primary outcome with 80% power and a two-sided significance level of alpha = 0.05. Based on results found by Lau et al. (2015), it is reasonable to assume that the primary outcome change will have a standard deviation of SD = 3.05. Assuming a moderately high within-subject correlation of r = 0.7 between baseline and post-intervention scores on the primary outcome, to achieve the desired statistical power using a baseline-adjusted ANCOVA model we would require a minimum of 13 participants in the intervention group and 13 in the intervention group for a total of n = 26.
Accounting for a dropout rate of 10%, we would require a minimum of n = 30 (15 in each group) recruited participants to detect a large effect size with 80% power, 5% significance and an assumed r = 0.7. As such we aim to recruit a minimum of 15 participants for the intervention group and 15 for the waitlist control group, allowing for a 10% drop out rate.




Data will be analysed using SPSS (Version 25). Descriptive statistics will be used to examine the survey responses at each time point. Following this, normality will be assessed using Shapiro-wilk, visual inspection of the histogram and box plot for outliers. T-tests will be employed to compare baseline measurements of demographic and condition specific variables between groups. Analysis of covariance (ANCOVA) will then be used to compare the changes in CAMS-R between the MBSR and control groups. Paired t-tests will be run to measure change in scores within groups for the secondary outcomes (CAMS-R total scores, Anxiety, Stress, Depression scores from the DASS-21; DERS total scores; pain intensity and interference scores; and point changes in ratings on a 10-point rating scale, across 5 individual specific anxiety inducing situations). P-values of <0.05 will be considered statistically significant. Where assumptions are not met, non-parametric Wilcoxon Signed Rank Test will be conducted, and change scores will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
31/08/2021
Actual
31/03/2022
Date of last data collection
Anticipated
31/10/2022
Actual
20/12/2022
Sample size
Target
35
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 308745 0
Other Collaborative groups
Name [1] 308745 0
Australian Centre for Health, Independence, Economic Participation and Value Enhanced Care for adolescents and young adults with cerebral palsy (CP-Achieve)
Country [1] 308745 0
Australia
Funding source category [2] 308748 0
Charities/Societies/Foundations
Name [2] 308748 0
Cerebral Palsy Alliance
Country [2] 308748 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 309647 0
None
Name [1] 309647 0
Address [1] 309647 0
Country [1] 309647 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308665 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 308665 0
Ethics committee country [1] 308665 0
Australia
Date submitted for ethics approval [1] 308665 0
17/03/2021
Approval date [1] 308665 0
17/05/2021
Ethics approval number [1] 308665 0
2021/239

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

Contacts
Principal investigator
Name 111478 0
Dr Hayley Smithers-Sheedy
Address 111478 0
Cerebral Palsy Alliance Research Institute
The University of Sydney
88 Mallet St
Camperdown
NSW 2050
Country 111478 0
Australia
Phone 111478 0
+61 405426148
Fax 111478 0
Email 111478 0
[email protected]
Contact person for public queries
Name 111479 0
Hayley Smithers-Sheedy
Address 111479 0
Cerebral Palsy Alliance Research Institute
The University of Sydney
88 Mallet St
Camperdown
NSW 2050
Country 111479 0
Australia
Phone 111479 0
+61 405426148
Fax 111479 0
Email 111479 0
[email protected]
Contact person for scientific queries
Name 111480 0
Hayley Smithers-Sheedy
Address 111480 0
Cerebral Palsy Alliance Research Institute
The University of Sydney
88 Mallet St
Camperdown
NSW 2050
Country 111480 0
Australia
Phone 111480 0
+61 405426148
Fax 111480 0
Email 111480 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
Due to the small sample size there would be concern that participant data could be identifying. We do not have ethics approval to allow IPD sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11879Study protocol  [email protected] nil



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.