Effects of cognitive behavioral therapy for depression on improving insomnia and quality of life in Chinese women with breast cancer: results of a randomized, controlled, multicenter trial

Figures & data

Table 1 Demographic and clinical characteristics

Characteristics	CBT (n=98)	SCM (n=98)	UC (n=196)	P-value
Age, mean (SD)	46.83 (8.91)	47.29 (8.72)	47.06 (8.32)	0.932
Height, mean, cm	159.85 (5.08)	159.67 (4.71)	160.08 (5.32)	0.806
Weight, mean, kg	58.34 (8.67)	59.81 (7.55)	57.52 (8.38)	0.082
Education, mean (SD), year	9.40 (3.09)	8.97 (4.04)	8.73 (3.39)	0.303
Marital status, n (%)				0.616
Single	6 (6.12)	3 (3.06)	10 (5.10)
Married/partner	92 (93.88)	95 (96.94)	186 (94.90)
Religion, n (%)				0.936
Religious	21 (21.43)	21 (21.43)	45 (22.96)
Non-religious	77 (78.57)	77 (78.57)	151 (77.04)
Sexual life, n (%)				0.850
Yes	71 (73.20)	74 (76.29)	144 (73.47)
No	26 (26.80)	23 (23.71)	52 (26.53)
Smoking, n (%)				0.150
Smoker	4 (4.08)	2 (2.04)	14 (7.14)
Non-smoker	94 (95.92)	96 (97.96)	182 (92.86)
Alcohol drinking, n (%)				0.155
Drinker	12 (12.24)	5 (5.10)	23 (11.73)
Non-drinker	86 (87.76)	93 (94.90)	173 (88.27)
Time since surgery, median (IQR), months	2.91 (0.33–4.40)	2.88 (0.28–3.75)	3.10 (0.33–5.83)	0.106
Cancer stage at diagnosis, n (%)				0.092
I	28 (28.57)	20 (20.41)	38 (19.39)
II	45 (45.92)	61 (62.24)	111 (56.63)
III	14 (14.29)	10 (10.20)	36 (18.37)
Unknown	11 (11.22)	7 (7.14)	11 (5.61)
Receiving hormone therapy, n (%)				1.000
Yes	7 (7.14)	7 (7.14)	14 (7.14)
No	91 (92.86)	91 (92.86)	182 (92.86)
Receiving radiation therapy, n (%)				0.372
Yes	11 (11.22)	14 (14.29)	34 (17.35)
No	87 (88.78)	84 (85.71)	162 (82.65)
Receiving chemotherapy, n (%)				0.730
Yes	71 (72.45)	75 (76.53)	142 (72.45)
No	27 (27.55)	23 (23.47)	54 (27.55)
Baseline HAMA score, mean (SD)	13.31 (5.09)a,b	11.52 (3.79)	11.01 (3.84)	<0.001
Baseline HAMD score, mean (SD)	13.37 (4.88)a,b	12.11 (3.19)	11.37 (2.74)	<0.001
Baseline AIS, mean (SD)	8.21 (4.32)	6.96 (4.45)	7.11 (4.42)	0.079
Baseline FACT-B (range), mean (SD)
Total score (0–144)	76.78 (19.91)	78.09 (18.86)	79.49 (21.06)	0.546
PWB	16.38 (4.83)	16.91 (5.07)	15.91 (5.37)	0.292
SWB	17.84 (5.10)	18.13 (5.70)	18.85 (4.22)	0.192
EWB	11.50 (6.30)	11.72 (6.65)	12.22 (6.56)	0.635
FWB	8.71 (5.89)	7.72 (5.28)	8.58 (5.92)	0.400
BCS	22.35 (5.41)a	23.60 (4.51)	23.92 (5.28)	0.045

Notes: Continuous variables are indicated as mean (SD) or median (IQR). Categorical values are expressed as proportions (%). The P-values reflect comparisons among CBT, SCM, and UC groups.

a P<0.05 compared with UC.

b P<0.05 compared with SCM.

Abbreviations: AIS, Athens Insomnia Scale; BCS, breast cancer-specific concerns; CBT, cognitive behavioral therapy; EWB, emotional well-being; FACT-B, Functional Assessment of Cancer Therapy-Breast; FWB, functional well-being; PWB, physical well-being; SCM, self-care management; SWB, social well-being; UC, usual care.

Figure 1 Flow chart of the participants through the randomized trial.

Abbreviations: CBT, cognitive behavioral therapy; SCM, self-care management; UC, usual care.

Table 2 RM-ANOVA for scores of AIS, total FACT-B, and five subscales of QOL among three groups

Factors	AIS	Total FACT-B	PWB	SWB	EWB	FWB	BCS
	Mean (SE)	Mean (SE)	Mean (SE)	Mean (SE)	Mean (SE)	Mean (SE)	Mean (SE)
Group
CBT	3.86 (0.30)a,b	98.30 (1.39)a,b	20.30 (0.34)a,b	20.32 (0.41)a,b	16.84 (0.44)a,b	14.58 (0.48)a,b	26.26 (0.24)a,b
SCM	6.03 (0.29)	85.34 (1.36)	17.95 (0.34)	18.44 (0.40)	13.12 (0.43)	11.12 (0.47)c	24.71 (0.24)
UC	6.46 (0.21)	81.64 (0.97)	16.98 (0.24)	18.41 (0.29)	12.53 (0.31)	9.65 (0.34)	24.08 (0.17)
ES	0.115	0.198	0.138	0.039	0.145	0.151	0.123
F-value	25.709	47.552	30.820	7.895	32.780	34.344	27.063
P-value	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001
Time
Baseline	7.26 (0.18)	78.87 (0.63)	16.57 (0.20)	18.33 (0.25)	12.03 (0.25)	8.49 (0.27)	23.45 (0.00)
4 weeks	5.76 (0.17)	83.07 (0.79)	16.97 (0.21)	18.65 (0.24)	13.17 (0.26)	10.43 (0.28)	23.85 (0.15)
12 weeks	4.67 (0.18)	93.19 (0.93)	18.97 (0.24)	19.44 (0.23)	15.47 (0.25)	13.37 (0.31)	25.94 (0.20)
24 weeks	4.32 (0.19)	98.57 (0.99)	21.12 (0.24)	19.82 (0.24)	15.97 (0.25)	14.83 (0.32)	26.84 (0.21)
ES	0.385	0.564	0.494	0.132	0.455	0.512	0.445
P-value	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001
Group × time
ES	0.109	0.137	0.033	0.070	0.129	0.094	0.109
P-value	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001

Notes:

a P<0.01 compared with SCM.

b P<0.01 compared with UC.

c P<0.05 compared with UC.

Abbreviations: AIS, Athens Insomnia Scale; BCS, breast cancer-specific concerns; CBT, cognitive behavior therapy; ES, effect size; EWB, emotional well-being; FACT-B, Functional Assessment of Cancer Therapy-Breast; FWB, functional well-being; PWB, physical well-being; RM-ANOVA, repeated measures ANOVA; SCM, self-care management; SE, standard error; SWB, social well-being; UC, usual care.

Figure 2 Mean score of AIS at baseline, 4, 12, and 24 weeks.

Abbreviations: AIS, Athens Insomnia Scale; CBT, cognitive behavioral therapy; SCM, self-care management; UC, usual care.

Figure 3 Mean scores of FACT-B subscales (A–E) and overall QOL (F) at baseline, 4, 12, and 24 weeks.

Abbreviations: BCS, breast cancer-specific concerns; CBT, cognitive behavior therapy; EWB, emotional well-being; FACT-B, Functional Assessment of Cancer Therapy-Breast; FWB, functional well-being; PWB, physical well-being; QOL, quality of life; SCM, self-care management; SWB, social well-being; UC, usual care.