Background
Methods
Design and population
Recruitment
Recruitment of the selected population to the non-randomised trial
Recruitment of the universal population to the randomised trial
Randomisation in the RCT
Outcome measures and data collection
Process evaluation
Face-to-face qualitative interviews with MindBabyBodyparticipants
Intervention
Data collection
Data analysis
Details of ethics approval
Results
Flowchart of participation
Socio-demographic characteristics
Non-randomised trial (selected population) (n = 20) | Randomised trial (universal population) (n = 32) | Randomised trial - intervention group (n = 17) | Randomised trial – care as usual group (n = 15) | |
---|---|---|---|---|
Age
| ||||
Mean (SD) | 33.70 (1.29) | 32.39 (0.65) | 30.81 (0.75) | 34.08 (0.90) |
Parity
| ||||
No prior births | 10/20 (50.0) | 27/32 (84.4) | 16/17 (94.1) | 11/15 (73.3) |
1 or more prior births | 10/20 (50.0) | 5/32 (15.6) | 1/17 (5.9) | 4/15 (26.7) |
Employment status
| ||||
Paid work | 13/20 (65.0) | 29/32 (90.6) | 16/17 (94.1) | 13/15 (86.7) |
Not in paid work | 7/20 (35.0) | 3/32 (9.4) | 1/17 (5.9) | 2/15 (13.3) |
Education level
| ||||
Higher university degree | 5/20 (25.0) | 14/32 (43.8) | 6/17 (35.3) | 8/15 (53.3) |
University degree | 10/20 (50.0) | 13/32 (40.6) | 7/17 (41.2) | 6/15 (40.0) |
Below university education | 5/20 (25.0) | 5/32 (15.6) | 4/17 (23.5) | 1/15 (6.7) |
Relationship status
| ||||
Married | 16/20 (80.0) | 21/32 (65.6) | 12/17 (70.6) | 9/15 (60.0) |
Living with partner | 2/20 (10.0) | 10/32 (31.3) | 4/17 (23.5) | 6/15 (40.0) |
Single | 2/20 (10.0) | 1/32 (3.1) | 1/17 (5.9) | 0/15 |
Born in Australia
| ||||
Yes | 8/20 (40.0) | 16/32 (50.0) | 7/17 (41.2) | 9/15 (60.0) |
No | 12/20 (60.0) | 16/32 (50.0) | 10/17 (58.8) | 6/15 (40.0) |
English first language
| ||||
Yes | 17/20 (85.0) | 26/32 (81.3) | 12/17 (70.6) | 14/15 (93.3) |
No | 3/20 (15.0) | 6/32 (18.7) | 5/17 (29.4) | 1/15 (6.7) |
Trimester at enrolment
| ||||
First | 0 | 8/32 (25.0) | 3/17 (17.7) | 5/15 (33.3) |
Second | 9/20 (45.0) | 20/32 (62.5) | 12/17 (70.6) | 8/15 (53.3) |
Third | 11/20 (55.0) | 4/32 (12.5) | 2/17 (11.8) | 2/15 (13.4) |
Baseline mental health
Non-randomised trial (selected population) (n = 20)*
|
Randomised trial (universal population) (n = 32)*
|
Comparison
| |||
---|---|---|---|---|---|
M (SD)
|
M (SD)
|
Mean difference (95% CI)
|
t (df)
|
p
| |
Depression
| |||||
CES-D depression | 23.18 (8.04) | 13.74 (8.68) | −9.43 (−14.57, −4.30) | −3.70 (46) |
<0.001
|
DASS depression | 12.95 (8.01) | 6.88 (8.30) | −6.07 (−10.84, −1.30) | −2.56 (49) |
0.01
|
Anxiety
| |||||
STAI state anxiety | 48.39 (12.59) | 35.83 (12.05) | −12.56 (−19.91, −5.20) | −3.44 (46) |
<0.001
|
DASS anxiety | 10.00 (7.54) | 7.25 (7.48) | −2.75 (−7.12, 1.62) | −1.27 (49) | 0.21 |
Stress
| |||||
PSS stress | 21.80 (4.99) | 17.06 (6.43) | −4.74 (−8.13, 1.35) | −2.81 (50) |
<0.001
|
DASS stress | 19.16 (7.25) | 13.88 (10.24) | −5.28 (−10.67, 0.10) | −1.97 (49) | 0.05 |
Mindfulness
| |||||
Nonreactivity | 18.74 (5.25) | 20.00 (6.04) | 1.23 (−2.16, 4.62) | 0.73 (47) | 0.47 |
Observing | 21.68 (4.97) | 24.03 (6.01) | 2.35 (−0.98, 5.67) | 1.42 (47) | 0.16 |
Acting with awareness | 23.68 (3.51) | 26.27 (5.97) | 2.58 (−0.46, 5.63) | 1.71 (47) | 0.10 |
Describing | 26.37 (4.79) | 27.29 (6.70) | 0.92 (−2.63, 4.47) | 0.52 (48) | 0.60 |
Nonjudging | 23.32 (5.96) | 25.87 (6.39) | 2.55 (−1.13, 6.23) | 1.40 (47) | 0.17 |
Full scale
| 113.79 (14.76) | 123.07 (20.74) | 9.28 (−1.79, 20.35) | 1.69 (46) | 0.10 |
Non-randomised trial (selected population)
|
Randomised trial (universal population)
| ||||||
---|---|---|---|---|---|---|---|
Clinical cut-off
|
Above clinical cut-off
|
Above clinical cut-off
| |||||
n
|
%
|
Range
|
n
|
%
|
Range
| ||
CESD depression | ≥ 16 | 12/17 | 71 | 10-34 | 10/31 | 32 | 2-32 |
DASS depression | ≥ 10 | 12/19 | 63 | 0-28 | 8/32 | 25 | 0-36 |
STAI state anxiety | ≥ 40 | 13/18 | 72 | 26-68 | 9/30 | 30 | 20-66 |
DASS anxiety | ≥8 | 11/19 | 58 | 2-28 | 10/32 | 31 | 0-28 |
DASS stress | ≥15 | 14/19 | 74 | 2-32 | 12/32 | 38 | 0-34 |
Pre-post comparison of outcome data
Non-randomised study outcome data
Pre-program M (SD)
|
Post-program M (SD)
|
Mean difference (95% CI)
| t (df) | p | |
---|---|---|---|---|---|
Depression
| |||||
CES-D depression | 24.60 (8.19) | 18.20 (9.13) | 6.40 (0.54, 12.26) | 2.47 (9) |
0.04
|
DASS depression | 13.80 (7.74) | 9.60 (6.10) | 4.20 (1.38, 7.01) | 3.37 (9) |
0.01
|
Anxiety
| |||||
STAI state anxiety | 49.67 (15.22) | 39.33 (8.26) | 10.33 (0.47, 20.20) | 2.42 (8) |
0.04
|
DASS anxiety | 10.20 (2.52) | 7.20 (4.54) | 3.00 (−1.88, 7.88) | 1.39 (9) | 0.20 |
Stress
| |||||
PSS stress | 22.46 (5.79) | 17.18 (5.84) | 5.27 (−0.86, 11.41) | 1.91 (10) | 0.09 |
DASS stress | 21.20 (9.00) | 16.60 (7.24) | 4.60 (−0.45, 9.64) | 2.06 (9) | 0.07 |
Mindfulness
| |||||
Nonreactivity | 18.00 (5.83) | 20.64 (5.71) | −2.64 (−6.48, 1.20) | −1.53 (10) | 0.16 |
Observing | 22.73 (3.17) | 25.55 (4.57) | −2.82 (−5.65, 0.01) | −2.22 (10) | 0.05 |
Acting with awareness | 24.09 (2.91) | 27.45 (4.30) | −3.36 (−5.43, −1.30) | −3.63 (10) |
0.01
|
Describing | 26.27 (4.56) | 29.91 (6.24) | −3.64 (−6.64, −0.63) | −2.69 (10) |
0.02
|
Nonjudging | 25.45 (5.87) | 27.18 (6.15) | −1.73 (−5.02, 1.57) | −1.17 (10) | 0.27 |
Full scale
| 116.55 (13.27) | 130.73 (19.83) | −14.18 (−23.13, −5.23) | −3.53 (10) |
0.01
|
RCT outcome data
MindBabyBody intervention group (n = 13)*
|
Care as usual group (n = 10)*
| |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Pre-program M (SD)
|
Post-program M (SD)
|
Within group comparison
|
Pre-program M (SD)
|
Post-program M (SD)
|
Within group comparison
| |||||
Mean diff (95% CI)
|
t (df)
|
p
|
Mean diff (95% CI)
|
t (df)
|
p
| |||||
Depression
| ||||||||||
CES-D depression | 14.42 (10.05) | 12.08 (4.17) | 2.33 (−4.60, 9.27) | 0.74 (11) | 0.47 | 13.70 (8.00) | 10.10 (8.72) | 3.60 (−1.40, 8.60) | 1.62 (9) | 0.14 |
DASS depression | 7.23 (6.66) | 4.31 (3.64) | 2.92 (−1.16, 7.01) | 1.56 (12) | 0.15 | 8.00 (11.20) | 5.60 (8.32) | 2.40 (−1.91, 6.71) | 1.26 (9) | 0.24 |
Anxiety
| ||||||||||
STAI state anxiety | 35.92 (14.11) | 32.83 (7.08) | 3.08 (−7.02, 13.19) | 0.67 (11) | 0.52 | 34.78 (11.51) | 33.00 (12.78) | 1.78 (6.55, 6.82) | 0.81 (8) | 0.44 |
DASS anxiety | 8.62 (7.72) | 4.62 (3.95) | 4.00 (0.69, 7.31) | 2.63 (12) |
0.02
| 7.00 (8.34) | 4.80 (5.90) | 2.2 (−0.92, 5.32) | 1.59 (9) | 0.15 |
Stress
| ||||||||||
PSS stress | 17.92 (7.14) | 16.54 (6.12) | 1.38 (−4.16, 6.93) | 0.54 (12) | 0.60 | 16.90 (7.08) | 14.40 (8.41) | 2.50 (−1.38, 6.38) | 1.46 (9) | 0.18 |
DASS stress | 16.15 (11.27) | 12.92 (5.01) | 3.23 (−3.74, 10.20) | 1.01 (12) | 0.33 | 13.40 (10.79) | 9.00 (4.92) | 4.40 (−2.89, 11.69) | 1.37 (9) | 0.20 |
Mindfulness
| ||||||||||
Nonreactivity | 20.58 (6.73) | 21.83 (4.45) | −1.25 (−4.89, 2.39) | −0.76 (11) | 0.47 | 19.70 (5.25) | 19.80 (4.78) | −0.10 (−1.83, 1.63) | −0.13 (9) | 0.90 |
Observing | 24.67 (5.25) | 29.92 (4.54) | −5.25 (−8.50, −2.00) | −3.55 (11) |
<0.001
| 24.80 (7.08) | 25.50 (7.28) | −0.70 (−4.82, 3.42) | −0.38 (9) | 0.71 |
Act with awareness | 25.75 (5.79) | 27.17 (4.00) | −1.42 (−4.91, 2.08) | −0.90 (11) | 0.39 | 25.90 (6.38) | 27.00 (2.98) | −1.10 (−4.71, 2.51) | −0.69 (9) | 0.51 |
Describing | 26.38 (6.79) | 28.62 (6.59) | −2.23 (−4.16, −0.30) | −2.52 (12) |
0.03
| 31.20 (5.18) | 31.40 (5.48) | −0.20 (−2.33, 1.93) | −0.21 (9) | 0.84 |
Nonjudging | 25.25 (7.06) | 27.58 (5.20) | −2.33 (−7.16, 2.49) | −1.06 (11) | 0.31 | 24.90 (3.41) | 29.80 (5.12) | −4.9 (−10.11, 0.31) | −2.13 (9) | 0.06 |
Full scale
| 121.55 (23.65) | 134.55 (20.55) | −13.0 (−27.79, 1.79) | −1.96 (10) | 0.07 | 126.50 (15.77) | 133.50 (12.43) | −7.0 (−15.53, 1.53) | −1.86 (9) | 0.10 |
Engagement with mindfulness practices
Qualitative results
Expectations and motivations
Experiences in the group
Engagement with mindfulness practice
Changes attributed to mindfulness practice
Discussion
Key findings
Target population
Recruitment
Retention
Engagement with mindfulness practice
Acceptability and discriminant ability of study measures
Outcome data
Strengths and limitations
Considerations for future trials
-
Employ recruitment strategies to engage younger, less educated, and more ethnically diverse women.
-
Implement strategies to increase participant retention - most notably undertaking recruitment as early as possible in pregnancy given that the most frequent reason for loss to follow-up was delivery of baby prior to follow-up.
-
Explore face-to-face contacts which occur earlier in pregnancy (i.e. the first hospital visit).
-
Reduce repetition in questionnaires, and aim to provide a more holistic picture of women’s health and wellbeing, drawing on learnings from large cohort studies which have achieved excellent retention rates over time [56].
-
Consider the use of an active control group, to avoid participant disappointment in the randomisation process, and to account for group effects.
-
Given the popularity of prenatal yoga (50% in the control group), careful measurement of this in future RCTs will be undertaken to assess the potential for bias.