Efficacy of Traditional Chinese Medicine psychosomatic integration therapy for subthreshold depression: a multicenter randomized controlled trial

doi:10.19852/j.cnki.jtcm.2026.02.011

Journal of Traditional Chinese Medicine ›› 2026, Vol. 46 ›› Issue (2): 392-400.DOI: 10.19852/j.cnki.jtcm.2026.02.011

• Original Articles • Previous Articles Next Articles

Efficacy of Traditional Chinese Medicine psychosomatic integration therapy for subthreshold depression: a multicenter randomized controlled trial

HU Wenyue¹(), ZHONG Biying², WANG Zhenyi³, ZHANG Meng⁴, CHANG Ze⁵, TAN Xi⁶, HAN Zhenyun⁷()

¹ Department of encephalopathy, Beijing University of Chinese Medicine Shenzhen Hospital (Longgang), Shenzhen 518000, China
² The Fifth Clinical Medical College of Beijing University of Chinese Medicine (Shenzhen Hospital), Shenzhen 518000, China
³ Department of General Traditional Chinese Medicine, Andingmen Community Health Service Center, Beijing 10010, China
⁴ Health Examination Center, Zaozhuang Hospital of Traditional Chinese Medicine, Zaozhuang 277000, China
⁵ Department of encephalopathy, Xiyuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100080, China
⁶ Hospital President's Office, Beijing University of Chinese Medicine Shenzhen Hospital (Longgang), Shenzhen 518000, China
⁷ Department of encephalopathy, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100071, China

Received:2024-11-23 Accepted:2025-06-25 Online:2026-04-15 Published:2026-04-04
Contact: HU Wenyue, Beijing University of Chinese Medicine Shenzhen Hospital (Longgang), Shenzhen 51800, China. maryhuyy@163.com; Telephone: +86-755-2833833-6302; Prof. HAN Zhenyun, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100071, China. tohanzhenyun@sina.com; Telephone: +86-10-67689653
About author:
HU Wenyue and ZHONG Biying are co-first authors and contributed equally to this work
Supported by:
Sanming Project of Medicine in Shenzhen(SZZYSM202105010);National Key Research and Development Program Project Fund: Clinical Evaluation of Interventions for Subthreshold Depression, Insomnia, and Mild Cognitive Impairment(2019YFC1710103)

1. .docx(3680KB)

Abstract

Abstract:

OBJECTIVE: To evaluate the efficacy of Traditional Chinese Medicine (TCM) psychosomatic integration therapy in treating subthreshold depression (SD).

METHODS: A multicenter randomized controlled trial was conducted. Eligible participants were evaluated by physicians and randomly assigned to either the intervention or control group. The intervention group received group psychotherapy, Jue tune music therapy, and Yuleyin oral formula (郁乐饮). The control group received only group psychotherapy. The intervention period lasted 12 weeks, followed by a 12-week follow-up. The primary outcome was the Center for Epidemiologic Studies Depression Scale (CES-D) score at week 12. Secondary outcomes included dropout rate, scores of the Hamilton Anxiety Scale (HAMA) and the Hamilton Depression Rating Scale (HAMD-17) at week 12, and CES-D scores at weeks 4, 8, 16, 20, and 24.

RESULTS: A total of 505 patients were randomly allocated to the two groups, and 496 participants [77% female; (38 ± 16) years] were included in the final analysis. The primary outcome showed no statistically significant difference in CES-D scores between the intervention and control groups at week 12 (P > 0.05). However, the intervention group exhibited significant reductions in CES-D scores at weeks 4, 8, 12, 16, 20, and 24 compared to baseline, and at week 24 compared to week 12 (P < 0.0001). The control group also showed significant reductions in CES-D scores at weeks 4 and 8 during the intervention period (P < 0.0001). Although no significant differences were observed between groups at each specific time point, the intervention group showed a more consistent downward trend. Additionally, both HAMD and HAMA scores significantly decreased from baseline to week 12 in both groups (P< 0.0001).

CONCLUSIONS: TCM psychosomatic integration therapy, which includes group psychotherapy, Jue tune music therapy, and Yuleyin oral formula, may be effective in improving symptoms of SD, with good safety and feasibility. The complete TCM intervention demonstrated better long-term effectiveness than group psychotherapy alone. Further high-quality studies are needed to validate these findings.

Key words: Traditional Chinese Medicine psychosomatic integration therapy, group psychotherapy, Jue tune music therapy, Yuleyin, randomized controlled trial

HU Wenyue, ZHONG Biying, WANG Zhenyi, ZHANG Meng, CHANG Ze, TAN Xi, HAN Zhenyun. Efficacy of Traditional Chinese Medicine psychosomatic integration therapy for subthreshold depression: a multicenter randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2026, 46(2): 392-400.

Figures/Tables 5

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Characteristics	Experimental group (n = 367)	Control group (n = 129)
Age (years)	39.2±16.5	36.3±14.7
Female [n (%)]	289 (78.7)	93 (72.1)
BMI (kg/m²)	23.8±6.2	24.6±7.2
CES-D	27.4±7.7	27.6±7.5
HAMD	11.3±2.9	10.9±3.0
HAMA	14.2±6.7	13.7±6.2
Without occupation [n (%)]	5 (1.4)	1 (0.8)
Education background [n (%)]
Master's degree or higher education	68 (18.5)	30 (23.3)
Bachelor's degree	142 (38.7)	45 (34.9)
Below high school diploma	157 (42.8)	54 (41.8)
Unmarried [n (%)]	155 (42.2)	61 (47.3)
Have smoking habits [n (%)]	27 (7.4)	12 (9.3)
Alcohol consumption patterns [n (%)]
No drink	305 (83.1)	109 (84.5)
Have a drinking habit	47 (12.8)	12 (9.3)
Used to have, but have quit now	15 (4.1)	8 (6.2)
Exercise Routines [n (%)]
Almost never exercise	113 (30.8)	31 (24.0)
Occasionally exercise	159 (43.3)	58 (45.0)
Regularly exercise	95 (25.9)	40 (31.0)

Characteristics	Experimental group (n = 367)	Control group (n = 129)
Age (years)	39.2±16.5	36.3±14.7
Female [n (%)]	289 (78.7)	93 (72.1)
BMI (kg/m²)	23.8±6.2	24.6±7.2
CES-D	27.4±7.7	27.6±7.5
HAMD	11.3±2.9	10.9±3.0
HAMA	14.2±6.7	13.7±6.2
Without occupation [n (%)]	5 (1.4)	1 (0.8)
Education background [n (%)]
Master's degree or higher education	68 (18.5)	30 (23.3)
Bachelor's degree	142 (38.7)	45 (34.9)
Below high school diploma	157 (42.8)	54 (41.8)
Unmarried [n (%)]	155 (42.2)	61 (47.3)
Have smoking habits [n (%)]	27 (7.4)	12 (9.3)
Alcohol consumption patterns [n (%)]
No drink	305 (83.1)	109 (84.5)
Have a drinking habit	47 (12.8)	12 (9.3)
Used to have, but have quit now	15 (4.1)	8 (6.2)
Exercise Routines [n (%)]
Almost never exercise	113 (30.8)	31 (24.0)
Occasionally exercise	159 (43.3)	58 (45.0)
Regularly exercise	95 (25.9)	40 (31.0)

Item		Experimental group (n = 367)	Control group (n = 129)	Mean difference (95% CI)	Wald χ² value	P value
Screening		27±8	28±8
Invention	Week 4	24±8	24±8	-0.01 (-1.57, 1.55)	0	0.99
	Week 8	22±8	22±8	0.09 (-1.47, 1.65)	0.012	0.91
	Week 12	20±7	20±8	-0.13 (-1.68, 1.43)	0.025	0.87
Follow-up	Week 16	20±8	21±8	-0.85 (-2.41, 0.71)	1.144	0.29
	Week 20	20±8	20±8	-0.50 (-2.06, 1.06)	0.396	0.53
	Week 24	19±8	20±9	-0.92 (-2.48, 0.64)	1.341	0.25
Time effect	Wald χ² value	898.14	275.91
Time effect	P value	<0.0001	<0.0001

Item		Experimental group (n = 367)	Control group (n = 129)	Mean difference (95% CI)	Wald χ² value	P value
Screening		27±8	28±8
Invention	Week 4	24±8	24±8	-0.01 (-1.57, 1.55)	0	0.99
	Week 8	22±8	22±8	0.09 (-1.47, 1.65)	0.012	0.91
	Week 12	20±7	20±8	-0.13 (-1.68, 1.43)	0.025	0.87
Follow-up	Week 16	20±8	21±8	-0.85 (-2.41, 0.71)	1.144	0.29
	Week 20	20±8	20±8	-0.50 (-2.06, 1.06)	0.396	0.53
	Week 24	19±8	20±9	-0.92 (-2.48, 0.64)	1.341	0.25
Time effect	Wald χ² value	898.14	275.91
Time effect	P value	<0.0001	<0.0001

Time	Experimental group (n = 367)			Control group (n = 129)
Time	Mean Difference (95% CI)	Wald χ² value	P value	Mean Difference (95% CI)	Wald χ ²value	P value
Week 16	0.02 (-0.48, 0.51)	0.01	0.944	0.74 (-0.10, 1.59)	2.958	0.085
Week 20	-0.29 (-0.78, 0.21)	1.27	0.259	0.09 (-0.76, 0.93)	0.043	0.837
Week 24	-1.11 (-1.61, -0.62)	19.4	<0.0001	-0.32 (-1.16, 0.53)	0.545	0.46
Time effect		26.43	<0.0001		6.39	0.094

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Items		Experimental group (n = 367)	Control group (n = 129)
HAMD	screening	11±3	11±3
	week 12	8±4^a	7±4^b
HAMA	screening	14±7	14±6
	week 12	10±6^a	9±7^b

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