Table 2 Analysis of main effects using MMRM for PHQ-9 score at week 6, with the delayed treatment as the control arm

From: Cognitive behavioral therapy skills via a smartphone app for subthreshold depression among adults in the community: the RESiLIENT randomized controlled trial

Triala

Component

n

Change scores from baseline of the PHQ-9

Differences in change scores of the PHQ-9 at week 6

Estimated least squares mean changeb

Effect sizec

Estimated least squares mean difference

Effect sizec

P value

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 6

Trial 1

BAd

Present

656

−1.47

−1.98

−2.23

−2.43

−2.51

−2.89

−1.07

(−1.37 to −0.77)

−1.28

(−1.62 to −0.93)

−0.38

(−0.48 to −0.27)

5.3 × 10−13

Absent

656

−0.70

−1.00

−1.29

−1.44

−1.69

−1.62

−0.60

(−0.90 to −0.30)

–

–

 

Trial 1

CR

Present

657

−1.27

−1.81

−2.15

−2.29

−2.36

−2.71

−1.00

(−1.30 to −0.70)

−0.90

(−1.25 to −0.56)

−0.27

(−0.37 to −0.16)

2.9 × 10−7

Absent

655

−0.90

−1.16

−1.37

−1.58

−1.84

−1.80

−0.67

(−0.97 to −0.37)

–

–

 

Trial 2

PS

Present

657

−1.41

−2.05

−2.33

−2.34

−2.69

−3.08

−1.14

(−1.40 to −0.88)

−0.91

(−1.25 to −0.57)

−0.27

(−0.37 to −0.17)

1.8 × 10−7

Absent

655

−1.35

−1.85

−1.73

−1.99

−2.00

−2.17

−0.81

(−1.07 to −0.55)

–

–

 

Trial 3

AT

Present

656

−1.34

−2.05

−2.32

−2.58

−2.76

−3.06

−1.13

(−1.44 to −0.81)

−0.87

(−1.22 to −0.51)

−0.24

(−0.34 to −0.14)

2.2 × 10−6

Absent

655

−1.36

−1.71

−1.76

−2.11

−2.21

−2.19

−0.81

(−1.12 to −0.50)

–

–

 

Trial 4

BIe

Present

627

−2.10

−2.52

−2.68

−3.01

−3.08

−3.38

−1.29

(−1.58 to −0.99)

−0.94

(−1.30 to −0.58)

−0.27

(−0.37 to −0.16)

3.8 × 10−7

Absent

624

−1.78

−1.95

−1.98

−2.21

−2.40

−2.44

−0.93

(−1.23 to −0.64)

–

–

 
  1. Least squares mean changes and differences in the PHQ-9 scores were estimated using MMRM. The regression models included fixed effects of treatment, visit (categorical) and treatment-by-visit interactions, adjusted for baseline PHQ-9 scores, employment status, age and gender. P values are two-sided and no adjustments are made for multiple comparisons.
  2. aSee Fig. 1 for the designs of trials 1 to 4.
  3. bA minus value indicates a reduction in depression. Values in parentheses are 95% CIs.
  4. cEffect sizes (SMD) were calculated using the observed baseline s.d. for within-group change scores and the observed week 6 s.d. for group differences.
  5. dThe effect size estimate of BA was obtained from the first 2 × 2 trial involving BA and CR, as per the SAP. The effect size estimates of BA from trials 2, 3 and 4 were −0.40 (−0.50 to −0.30), −0.35 (−0.45 to −0.25) and −0.30 (−0.40 to −0.20), respectively.
  6. eParticipants working on a three-shift schedule were excluded in the primary and sensitivity analyses for trial 4.
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