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Trial registered on ANZCTR


Registration number
ACTRN12614000523606
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
16/05/2014
Date last updated
5/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of mindfulness training on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial.
Scientific title
In pregnant women, does mindfulness training, compared to pregnancy support, reduce maternal stress and depressive symptoms, and increase awareness of present moment experience?
Secondary ID [1] 284592 0
None
Universal Trial Number (UTN)
U1111-1156-7824
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291887 0
Stress 291888 0
Anxiety 291889 0
Pregnancy 291915 0
Condition category
Condition code
Mental Health 292229 292229 0 0
Depression
Mental Health 292230 292230 0 0
Anxiety
Reproductive Health and Childbirth 292264 292264 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness group training. The Mindfulness in Pregnancy Program (MiPP) drew on the theoretical constructs of mindfulness and cognitive behavioural therapy adapted for a pregnant population and was informed by the work of Cassandra Vieten’s Mindful Motherhood program (Vieten, 2009; Vieten and Astin, 2008) and Nancy Bardacke’s Mindfulness-Based Childbirth and Parenting program (MBCP) (Bardacke, 2012). Content included experiential learning to enhance awareness, acceptance, compassion, connection and mindfulness in everyday life. The co-emergence model of behaviour reinforcement was built into the MiPP (Cayoun, 2015). This MiPP consisted of 2-hour, weekly sessions, for 8 weeks, using mindfulness of thoughts and feelings through breath awareness, mindfulness of body through guided body scanning and movement practices, and observing self, being present to self and baby, Small groups sessions with a total of 12 were conducted by a registered nurse/midwife trained with a Graduate Diploma in Mindfulness-integrated CBT, experienced in conducting mindfulness programs.
Intervention code [1] 289364 0
Prevention
Intervention code [2] 289384 0
Behaviour
Comparator / control treatment
Pregnancy Support Group (PSP) consisted of an 8-week support group of 2-hour, weekly sessions. Following limited direction from the facilitator, women were encouraged to put forward issues that they would like to have supported. The PSP utilised a generalised midwifery approach to the topics without the mindfulness concepts or practices. PSP topics included: communication, empathy, body image, pain relief options, breastfeeding, caring for the newborn, and mental health and postnatal depression. Class activities included: identification and discussion of stressors (including finances), active listening, identifying own strengths, wants versus needs, self-portrait highlighting physical changes, emotional response to birthing, and breastfeeding images; envisaging support networks, brainstorming resources and childcare options.
Control group
Active

Outcomes
Primary outcome [1] 292102 0
Primary Outcome 1: Perceived Stress Scale; mean difference in pre-, post-, and 6-week post-intervention scores.
Timepoint [1] 292102 0
Pre-intervention, immediately post-intervention and 6 weeks post-intervention
Primary outcome [2] 292103 0
Primary Outcome 2: Edinburgh Postnatal Depression Scale; ; mean difference in pre-, post-, and 6-week post-intervention scores
Timepoint [2] 292103 0
Pre-intervention, immediately post-intervention and 6 weeks post-intervention
Primary outcome [3] 292104 0
Primary Outcome 3: Mindfulness Attention Awareness Scale; mean difference in pre-, post-, and 6-week post-intervention scores.
Timepoint [3] 292104 0
Pre-intervention, immediately post-intervention and 6 weeks post-intervention
Secondary outcome [1] 308209 0
A program satisfaction questionnaire prepared specifically for this study was administered immediately following the program, in paper format; identifying participants' perceptions of what they learnt, impact of the program, what they liked most and least, whether they would recommend the intervention, and other comments.
Timepoint [1] 308209 0
Completed immediately following the intervention.

Eligibility
Key inclusion criteria
Low risk pregnancy in the second trimester at the start of the intervention; 18 years or older; able to read and speak English; having a planned hospital birth; and those who commit to attending all eight sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of mental illness; known inability to attend more than four sessions; a score 13 or higher on the Edinburgh Postnatal Depression Scale, and who answer in the affirmative to question 10 indicating that they have considered self-harm.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once women show an interest in participation and meet the inclusion criteria, they will be given the participant information sheet and consent form to read and given the opportunity to ask questions. If they consent to participate in the study, randomisation will proceed by the researcher taking a concealed, opaque envelope and allocating the intervention group accordingly. Allocation of intervention groups has have been done by an off-site researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomisation was used and the block size is concealed from the recruiting researchers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 24 women in each group would replicate the mean difference of 3.5 between pre- and post-intervention Perceived Stress Scale scores found by Vietan and Austin *, with 80% power, p=0.05, 2-tailed and allowing for attrition of 30%. (*Vieten, C. and J. Astin, Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: Results of a pilot study. Archives of Women's Mental Health, 2008. 11(1): p. 67-74.)
Quantitative data will be analysed using descriptive statistics. Repeated measures MANOVA will be used to analyse between- and within-group differences in the survey scores. Content analysis of qualitative data will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
29/08/2014
Actual
1/08/2014
Date of last data collection
Anticipated
Actual
2/12/2014
Sample size
Target
50
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2458 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 8115 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 289225 0
Charities/Societies/Foundations
Name [1] 289225 0
Nurses Board of Victoria Legacy Limited (NBVLL)
Country [1] 289225 0
Australia
Primary sponsor type
Individual
Name
Jill Beattie
Address
School of Nursing and Midwifery
Monash University
PO Box 527
Frankston Vic 3165
Country
Australia
Secondary sponsor category [1] 287896 0
Individual
Name [1] 287896 0
Christine East
Address [1] 287896 0
Monash University / Monash Health
c/- Birth Suite
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country [1] 287896 0
Australia
Other collaborator category [1] 277945 0
Individual
Name [1] 277945 0
Helen Hall
Address [1] 277945 0
School of Nursing and Midwifery
Monash University
PO Box 527
Frankston, Victoria, 3199
Country [1] 277945 0
Australia
Other collaborator category [2] 277946 0
Individual
Name [2] 277946 0
Rosalind Lau
Address [2] 277946 0
School of Nursing & Midwifery
Monash University, Clayton Campus
Wellington Rd
Clayton, Victoria 3800
Country [2] 277946 0
Australia
Other collaborator category [3] 277947 0
Individual
Name [3] 277947 0
Mary Anne Biro
Address [3] 277947 0
School of Nursing & Midwifery
Building G, Peninsula Campus
Monash University
McMahons Road, Frankston VIC 3199
Country [3] 277947 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290992 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 290992 0
Ethics committee country [1] 290992 0
Australia
Date submitted for ethics approval [1] 290992 0
Approval date [1] 290992 0
24/04/2014
Ethics approval number [1] 290992 0
14103B
Ethics committee name [2] 290993 0
Monash University Human Research Ethics Commitee
Ethics committee address [2] 290993 0
Ethics committee country [2] 290993 0
Australia
Date submitted for ethics approval [2] 290993 0
Approval date [2] 290993 0
07/05/2014
Ethics approval number [2] 290993 0
CF14/1361 - 2014000636

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

Contacts
Principal investigator
Name 48330 0
Dr Jill Beattie
Address 48330 0
Monash University,
PO Box 527
Frankston
VIC, 3165
Country 48330 0
Australia
Phone 48330 0
+61 0414835408
Fax 48330 0
Email 48330 0
[email protected]
Contact person for public queries
Name 48331 0
Jill Beattie
Address 48331 0
Monash University,
PO Box 527
Frankston
VIC, 3165
Country 48331 0
Australia
Phone 48331 0
+61 0414835408
Fax 48331 0
Email 48331 0
[email protected]; [email protected]
Contact person for scientific queries
Name 48332 0
Jill Beattie
Address 48332 0
Monash University,
PO Box 527
Frankston
VIC, 3165
Country 48332 0
Australia
Phone 48332 0
+61 03 9904 4653
Fax 48332 0
Email 48332 0
[email protected]

No information has been provided regarding IPD availability


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.