Table 1
Outcomes, method(s) of assessment and timing of assessments. Q, questionnaire; ESM, experience sampling method.
| OUTCOMES | METHOD(S) OF ASSESSMENT | TIMING OF ASSESSMENT | ||
|---|---|---|---|---|
| BASELINE | 1.5 MONTHS | 3 MONTHS | ||
| Primary outcome measures | ||||
| Quality of life | Self-report Q | X | X | X |
| Emotional distress | ESM | X | X | X |
| Self-report Q | X | X | X | |
| Secondary outcome measures | ||||
| Mindfulness skills | Self-report Q | X | X | X |
| ESM | X | X | X | |
| Repetitive negative thinking | Self-report Q | X | X | X |
| Self-compassion | Self-report Q | X | X | X |
| User-rated quality of the app | Self-report Q | X | ||
| Use of the app | App-tracking | X | X | X |
| Background information | Self-report Q | X | ||
Figure 1
App interface showing the six consecutive mindfulness modules.
Figure 2
CONSORT flowchart of participants.
Note. T1 = 1.5 months after randomisation; T2 = 3 months after randomisation.
a The ♀♂ symbol denotes the total number of couples participating in the study, with each couple counted as two individual participants.
Table 2
Sociodemographic Characteristics of Participants at Baseline.
| Baseline characteristic | n (%) | p | |
|---|---|---|---|
| CONTROL | INTERVENTION | ||
| Age: M ± SD | 32.3 ± 3.2 | 31.3 ± 3.9 | .23 |
| Sex: ♂/♀ | 6 (16)/32 (84) | 5 (15)/29 (85) | .9 |
| Employment status | .8 | ||
| Full timea | 29 (76) | 27 (79) | |
| Parttimea | 6 (16) | 6 (18) | |
| Unemployed, deliberately unemployed, incapacitateda | 3 (8) | 1 (3) | |
[i] Note. M = mean; SD = standard deviation.
a Reflects the number and percentage of participants answering ‘yes’ to this question.
Table 3
Descriptive Statistics of the Primary Outcomes.
| SYMPTOMS OF EMOTIONAL DISTRESS | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| FERTIQOL | DASS-21 | ESM | ||||||||
| WAVE | ||||||||||
| Group | Statistic | T0 | T1 | T2 | T0 | T1 | T2 | T0 | T1 | T2 |
| C | M | 56.9 | 42.4 | 58.9 | 40.8 | 40.8 | 39.1 | 19.1 | 20 | 16.7 |
| SD | 13.3 | 12.8 | 11.8 | 19.4 | 21.7 | 23.6 | 9.1 | 15.5 | 9.1 | |
| n | 34 | 23 | 18 | 38 | 24 | 20 | 28 | 12 | 15 | |
| Missing | 4 | 8 | 12 | 0 | 7 | 10 | 10 | 19 | 15 | |
| I | M | 59.4 | 46.4 | 63.1 | 38.3 | 36.2 | 25.2 | 21.5 | 19 | 19.7 |
| SD | 13.2 | 9.9 | 12.9 | 20.4 | 20.7 | 15.1 | 13 | 14.3 | 13.8 | |
| n | 33 | 24 | 20 | 34 | 25 | 20 | 31 | 18 | 13 | |
| Missing | 1 | 6 | 6 | 0 | 5 | 6 | 3 | 12 | 13 | |
[i] Note. FertiQoL = fertility related quality of life; DASS-21 = depression, anxiety, and stress scale – 21 items; ESM = experience sampling method; T0 = baseline; T1 = 1.5 months after randomisation; T2 = 3 months after randomisation; C = control; I = intervention.
Table 4
Descriptive Statistics of the Secondary Outcomes.
| MINDFULNESS SKILLS | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PTQ | CHIME-SF | ESM | SCS-SF | ||||||||||
| WAVE | |||||||||||||
| GROUP | STATISTIC | T0 | T1 | T2 | T0 | T1 | T2 | T0 | T1 | T2 | T0 | T1 | T2 |
| C | M | 34.5 | 33 | 32.2 | 83 | 80 | 79 | 57 | 58.9 | 62 | 2.7 | 2.6 | 2.6 |
| SD | 10.5 | 9.7 | 8.4 | 14 | 11 | 11 | 10.2 | 7.8 | 10.8 | .7 | .7 | .6 | |
| n | 38 | 24 | 20 | 38 | 24 | 20 | 28 | 12 | 15 | 38 | 24 | 20 | |
| Missing | 0 | 7 | 10 | 0 | 7 | 10 | 10 | 19 | 15 | 0 | 7 | 10 | |
| I | M | 32 | 31 | 26 | 83 | 87 | 90 | 56.6 | 61.7 | 61.4 | 2.9* | 3.1 | 3.3* |
| SD | 11 | 9 | 10 | 13 | 13 | 14 | 13 | 11.8 | 11.3 | .6 | .7 | .7 | |
| n | 34 | 24 | 20 | 34 | 24 | 20 | 31 | 18 | 13 | 34 | 24 | 20 | |
| Missing | 0 | 6 | 6 | 0 | 6 | 6 | 3 | 12 | 13 | 0 | 6 | 6 | |
[i] Note. PTQ = perseverative thinking questionnaire; CHIME = comprehensive inventory of mindfulness experiences; ESM = experience sampling method; SCS-SF = self-compassion scale – short form; T0 = baseline; T1 = 1.5 months after randomisation; T2 = 3 months after randomisation; C = control; I = intervention.
*p < .05.
Table 5
Results of HLM Estimating the Intervention and Time effect on Primary Outcomes.
| OUTCOME | FACTORS | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| T0 | T1 | T2 | I | T1 × I | T2 × I | ||||||
| β0 ± SE | β ± SE | pa | β ± SE | pa | β ± SE | pa | β ± SE | pa | β ± SE | pa | |
| FertiQoL | 57.08 ± 2.1 | –14.52 ± 1.5 | <.001 | 2.01 ± 1.9 | .31 | 2.29 ± 3.1 | .46 | 1.19 ± 2.1 | .56 | 1.17 ± 2.7 | .66 |
| DASS-21 | 40.79 ± 3.3 | 0.70 ± 3.9 | .86 | –3.12 ± 4.2 | .46 | –2.50 ± 4.8 | .61 | –1.78 ± 5.5 | .75 | –7.87 ± 6 | .19 |
| ESM | 19.07 ± 2.2 | 0.71 ± 3 | .81 | –1.75 ± 2.7 | .52 | 2.39 ± 3.1 | .44 | –4.19 ± 3.8 | .28 | –1.55 ± 3.9 | .69 |
[i] Note. FertiQoL = fertility quality of life; DASS-21 = depression, anxiety, and stress scale – 21 items; ESM = experience sampling method; T1 = 1.5 months after randomisation; T2 = 3 months after randomisation; I = intervention group.
a Satterthwaite’s method for t-tests.
Table 6
Results of HLM Estimating the Intervention and Time effect on Secondary Outcomes.
| OUTCOME | FACTORS | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| T0 | T1 | T2 | I | T1 × I | T2 × I | ||||||
| β0 ± SD | β ± SD | pa | β ± SD | pa | β ± SD | pa | β ± SD | pa | β ± SD | pa | |
| PTQ | 34.45 ± 1.7 | –1.55 ± 1.6 | .34 | –3.68 ± 2.4 | .13 | –2.33 ± 2.4 | .34 | –0.21 ± 2.3 | .93 | –2.39 ± 3.4 | .48 |
| mindfulness ESM | 57.23 ± 2.1 | 1.43 ± 2.5 | .57 | 3.55 ± 2.4 | .14 | –0.67 ± 3 | .82 | 5.33 ± 3.3 | .11 | 3.73 ± 3.4 | .28 |
| mindfulness CHIME | 126.82 ± 3 | –2.62 ± 2.5 | .31 | –4 ± 3.4 | .25 | 0.74 ± 4.4 | .87 | 8.80 ± 3.6 | .02* | 11.68 ± 4.8 | .02* |
| SCS-SF | 2.69 ± 0.1 | 0.01 ± 0.1 | .94 | –0.04 ± 0.1 | .76 | 0.16 ± 0.2 | .33 | 0.24 ± 0.1 | .08 | 0.49 ± 0.2 | .006** |
[i] Note. PTQ = perseverative thinking questionnaire; ESM = experience sampling method; CHIME = comprehensive inventory of mindfulness experiences; SCS-SF = self-compassion scale – short form; T1 = 1.5 months after randomisation; T2 = 3 months after randomisation; I = intervention group.
a Satterthwaite’s method for t-tests.
*p < .05.
**p < .01.