Cognitive-behavioral stress management relieves anxiety, depression, and post-traumatic stress disorder in parents of pediatric acute myeloid leukemia patients: a randomized, controlled study

Figures & data

Figure 1. Chart illustrating the study flow. A total of 56 pediatric AML patients and 100 parents were enrolled and randomized into the CBSM group and the NC group to receive 10-week CBSM and NC, respectively. The questionnaire scores were evaluated at M0, M1, M3, and M6.

Table 1. Clinical characteristics of pediatric AML patients.

Items	NC group (N = 28)	CBSM group (N = 28)	T/χ^2/Z value	p value
Age (years), mean ± SD	6.9 ± 2.6	7.1 ± 3.0	−0.286	0.776
Male, n (%)	16 (57.1)	19 (67.9)	0.686	0.408
Height (cm), median (IQR)	118.5 (104.0-135.8)	119.5 (106.3-124.0)	−0.098	0.922
Weight (kg), median (IQR)	21.0 (17.6-28.7)	23.3 (18.7-30.0)	−0.311	0.755
FAB classification, n (%)			3.949	0.290
M1	3 (10.7)	1 (3.6)
M2	13 (46.4)	14 (50.0)
M4	1 (3.6)	5 (17.9)
M5	11 (39.3)	8 (28.6)
Cytogenetics, n (%)			8.388	0.516
NK	9 (32.1)	8 (28.6)
t (8;21)	5 (17.9)	4 (14.3)
Inv (16) or t (16;16)	5 (17.9)	3 (10.7)
CK	5 (17.9)	2 (7.1)
−7 or 7q-	0 (0.0)	3 (10.7)
t (9;22)	1 (3.6)	1 (3.6)
+8	0 (0.0)	2 (7.1)
t (9;11)	0 (0.0)	1 (3.6)
11q23	0 (0.0)	1 (3.6)
Others (not included in better or poor risk)	3 (10.7)	3 (10.7)
FLT3-ITD, n (%)	9 (32.1)	5 (17.9)	1.524	0.217
CEBPA mutation, n (%)	6 (21.4)	5 (17.9)	0.113	0.737
NPM1 mutation, n (%)	8 (28.6)	4 (14.3)	1.697	0.193
WT1 mutation, n (%)	5 (17.9)	4 (14.3)	0.132	1.000
WBC (10^9/L), median (IQR)	30.4 (12.4-52.1)	33.3 (24.3-47.7)	−1.049	0.294
BM blasts (%), mean ± SD	75.1 ± 11.4	71.0 ± 17.6	1.037	0.304
NCCN risk stratification (2013), n (%)			−0.663	0.508
Favorable	13 (46.4)	9 (32.1)
Intermediate	6 (21.4)	10 (35.7)
Poor	9 (32.1)	9 (32.1)
Chinese Medical Association risk stratification, n (%)			−0.576	0.565
Low risk	4 (14.3)	3 (10.7)
Median risk	12 (42.9)	11 (39.3)
High risk	12 (42.9)	14 (50.0)

Notes: AML, acute myeloid leukemia; NC, normal care; CBSM, cognitive-behavioral stress management; SD, stander deviation; IQR, inter-quartile range; FAB, French-American-British; FLT3, FMS-like tyrosine kinase 3; ITD, internal tandem duplication; CEBPA, CCAAT/enhancer-binding protein alpha; NPM1, Nucleophosmin 1; WT1, Wilms’ tumor-1; WBC, white cell count; BM, bone marrow; NCCN, national comprehensive cancer network.

Table 2. Clinical characteristics of parents.

Items	NC group (N = 51)	CBSM group (N = 49)	T/χ^2/Z value	p value
Relation, n (%)			0.170	0.680
Mother	26 (51.0)	27 (55.1)
Father	25 (49.0)	22 (44.9)
Age (years), mean ± SD	35.6 ± 4.1	35.2 ± 3.8	0.540	0.591
Smoker, n (%)			1.966	0.374
Never	31 (60.8)	34 (69.4)
Former	7 (13.7)	8 (16.3)
Current	13 (25.5)	7 (14.3)
Drinker, n (%)	20 (39.2)	14 (28.6)	1.262	0.261
Marriage status, n (%)			0.475	0.491
Married	46 (90.2)	42 (85.7)
Divorced/widowed	5 (9.8)	7 (14.3)
Employment status, n (%)			0.572	0.449
Employed	42 (82.4)	43 (87.8)
Unemployed	9 (17.6)	6 (12.2)
Level of education, n (%)			0.824	0.844
Primary school or less	3 (5.9)	5 (10.2)
High school	24 (47.1)	20 (40.8)
Undergraduate	19 (37.3)	19 (38.8)
Graduate or above	5 (9.8)	5 (10.2)
Rural, n (%)	8 (15.7)	10 (20.4)	0.377	0.539
Family annual income, n (%)			2.868	0.238
10,000–29,999 CNY	10 (19.6)	15 (30.6)
30,000–49,999 CNY	21 (41.2)	13 (26.5)
≥ 50,000 CNY	20 (39.2)	21 (42.9)
Hypertension, n (%)	7 (13.7)	6 (12.2)	0.048	0.826
Hyperlipidemia, n (%)	5 (9.8)	2 (4.1)	1.257	0.437
Diabetes, n (%)	3 (5.9)	1 (2.0)	0.960	0.618

Notes: NC, normal care; CBSM, cognitive-behavioral stress management; SD, stander deviation; CNY, Chinese yuan.

Table 3. Comparison of SAS score and anxiety in parents.

Items	NC group (N = 51)	CBSM group (N = 49)	T/χ^2 value	p value
SAS score, mean ± SD
M0	50.3 ± 12.0	51.1 ± 12.1	−0.334	0.739
M1	51.0 ± 11.3	46.1 ± 11.3	2.155	0.034
M3	50.6 ± 10.2	45.0 ± 11.2	2.622	0.010
M6	50.7 ± 10.6	44.2 ± 11.0	3.028	0.003
Anxiety, n (%)
M0	24 (47.1)	24 (49.0)	0.037	0.848
M1	24 (47.1)	16 (32.7)	2.161	0.142
M3	25 (49.0)	14 (28.6)	4.392	0.036
M6	26 (51.0)	13 (26.5)	6.279	0.012

Notes: SAS, self-rating anxiety scale; NC, normal care; CBSM, cognitive-behavioral stress management; SD, stander deviation; M0, at discharge; M1, the 1st month after discharge; M3, the 3rd month after discharge; M6, the 6th month after discharge.

Table 4. Comparison of SDS score and depression in parents.

Items	NC group (N = 51)	CBSM group (N = 49)	T/χ^2 value	p value
SDS score, mean ± SD
M0	49.1 ± 11.1	50.3 ± 11.9	−0.524	0.602
M1	49.4 ± 9.1	46.5 ± 9.0	1.591	0.115
M3	50.3 ± 10.3	45.8 ± 9.2	2.328	0.022
M6	49.7 ± 9.7	43.9 ± 8.3	3.167	0.002
Depression, n (%)
M0	21 (41.2)	23 (46.9)	0.337	0.562
M1	22 (43.1)	16 (32.7)	1.166	0.280
M3	25 (49.0)	15 (30.6)	3.528	0.060
M6	24 (47.1)	12 (24.5)	5.525	0.019

Notes: SDS, self-rating depression scale; NC, normal care; CBSM, cognitive-behavioral stress management; SD, stander deviation; M0, at discharge; M1, the 1st month after discharge; M3, the 3rd month after discharge; M6, the 6th month after discharge.

Table 5. Comparison of SCL-90 score in parents.

Items	NC group (N = 51)	CBSM group (N = 49)	T value	p value
SCL-90 score, mean ± SD
M0	138.8 ± 24.7	140.3 ± 26.2	−0.299	0.766
M1	134.3 ± 24.3	126.9 ± 26.9	1.450	0.150
M3	133.5 ± 24.3	122.3 ± 26.7	2.192	0.031
M6	131.7 ± 24.3	119.6 ± 26.5	2.380	0.019

Notes: SCL-90, Symptom Checklist-90; NC, normal care; CBSM, cognitive-behavioral stress management; SD, stander deviation; M0, at discharge; M1, the 1st month after discharge; M3, the 3rd month after discharge; M6, the 6th month after discharge.

Table 6. Comparison of IES-R score in parents.

Items	NC group (N = 51)	CBSM group (N = 49)	T value	p value
IES-R score, mean ± SD
M0	23.4 ± 10.8	24.0 ± 14.2	−0.234	0.815
M1	22.9 ± 10.3	20.1 ± 9.8	1.357	0.178
M3	22.6 ± 11.5	18.2 ± 10.4	2.043	0.044
M6	21.5 ± 11.7	15.8 ± 9.9	2.614	0.010

Notes: IES-R, impact of events scale-revised; NC, normal care; CBSM, cognitive-behavioral stress management; SD, stander deviation; M0, at discharge; M1, the 1st month after discharge; M3, the 3rd month after discharge; M6, the 6th month after discharge.

Table 7. Subgroup analysis of outcomes at M6 in parents.

Items	NC group (N = 51)	CBSM group (N = 49)	T/χ^2 value	p value
No anxiety at M0
SAS score, mean ± SD	48.0 ± 10.5	43.7 ± 8.3	1.637	0.108
Anxiety, n (%)	8 (29.6)	4 (16.0)	1.358	0.244
SDS score, mean ± SD	47.2 ± 9.9	42.3 ± 8.8	1.899	0.063
Depression, n (%)	9 (33.3)	5 (20.0)	1.173	0.279
SCL-90 score, mean ± SD	123.4 ± 26.8	118.6 ± 27.1	0.644	0.523
IES-R score, mean ± SD	20.3 ± 12.8	15.3 ± 10.1	1.575	0.122
Anxiety at M0
SAS score, mean ± SD	53.7 ± 10.0	44.7 ± 13.4	2.650	0.011
Anxiety, n (%)	18 (75.0)	9 (37.5)	6.857	0.009
SDS score, mean ± SD	52.5 ± 9.0	45.7 ± 7.6	2.831	0.007
Depression, n (%)	15 (62.5)	7 (29.2)	5.371	0.020
SCL-90 score, mean ± SD	141.0 ± 17.2	120.7 ± 26.5	3.158	0.003
IES-R score, mean ± SD	22.8 ± 10.5	16.4 ± 9.9	2.184	0.034
No-depression at M0
SAS score, mean ± SD	49.7 ± 10.5	44.2 ± 11.2	1.879	0.066
Anxiety, n (%)	13 (43.3)	6 (23.1)	2.549	0.110
SDS score, mean ± SD	48.5 ± 8.5	44.2 ± 8.4	1.917	0.060
Depression, n (%)	12 (40.0)	7 (26.9)	1.063	0.303
SCL-90 score, mean ± SD	125.4 ± 26.3	116.5 ± 27.3	1.235	0.222
IES-R score, mean ± SD	20.7 ± 10.9	16.6 ± 9.8	1.459	0.150
Depression at M0
SAS score, mean ± SD	52.1 ± 10.7	44.1 ± 10.9	2.455	0.018
Anxiety, n (%)	13 (61.9)	7 (30.4)	4.385	0.036
SDS score, mean ± SD	51.3 ± 11.4	43.7 ± 8.3	2.573	0.014
Depression, n (%)	12 (57.1)	5 (21.7)	5.803	0.016
SCL-90 score, mean ± SD	140.7 ± 18.0	123.0 ± 25.8	2.605	0.013
IES-R score, mean ± SD	22.6 ± 12.9	14.9 ± 10.1	2.219	0.032

Notes: M6, the 6th months after discharge; NC, normal care; CBSM, cognitive-behavioral stress management; M0, at discharge; SAS, self-rating anxiety scale; SD, stander deviation; SDS, self-rating depression scale; SCL-90, Symptom Checklist-90; IES-R, impact of events scale-revised.