Integrated rehabilitation for post-stroke anxiety: a prospective, multicenter, randomized controlled trial
5 affiliations
- 1The Third Clinical College of Zhejiang Chinese Medical University
- 2Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University
- 3Department of Rehabilitation, Zhejiang General Hospital of the Armed Police
- 4Department of Acupuncture and Rehabilitation, Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University
- 5Department of Psychiatry, The Second Hospital of Jinhua
Abstract
Introduction: Post-stroke anxiety (PSA) affects approximately one-quarter of stroke survivors and impedes functional recovery, yet pharmacological options remain limited by inconsistent efficacy and absent standardized guidelines. This study evaluated an integrated rehabilitation program combining repetitive transcranial magnetic stimulation (rTMS), acupuncture, and Chinese herbal medicine for PSA.
Methods: In this multicenter randomized controlled trial, 188 participants with mild-to-moderate PSA were randomized 1:1 to standard care (pharmacotherapy, general care, and exercise therapy) or integrated rehabilitation (standard care plus rTMS, acupuncture, and Chinese herbal medicine) for 4 weeks, with an 8-week follow-up. The primary outcome was the Hamilton Anxiety Rating Scale (HAM-A). Secondary outcomes included the Self-Rating Anxiety Scale (SAS), Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Montreal Cognitive Assessment (MoCA), Fugl–Meyer Assessment (FMA), and Pittsburgh Sleep Quality Index (PSQI). Analyses followed an intention-to-treat framework.
Results: The integrated rehabilitation group showed significantly greater reductions in HAM-A scores at Week 4 than controls (between-group difference, 2.49 points; 95% CI, 1.50 to 3.48; p <0.01), and this treatment benefit was maintained at week 12 (p<0.01). In supportive analyses of the secondary outcomes, Holm-adjusted group × time interactions remained significant for PSQI, MoCA, upper-extremity motor function, ADL, and SAS scores (all adjusted p<0.05), but not for lower-extremity motor function or IADL.
Discussion: The integrated rehabilitation program improved the primary anxiety outcome and provided supportive evidence of broader clinical benefits in sleep quality, cognition, and upper-extremity motor function, together with distinct patterns of functional change in ADL and IADL. Overall, these findings support further consideration of this integrated approach as an adjunct to pharmacotherapy for PSA. Biological mechanisms and contributions of individual intervention components remain undetermined. Further mechanistic investigations incorporating biological measures would help clarify the underlying mechanisms.
Clinical trial registration: https://clinicaltrials.gov/ , identifier NCT05147077.
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BibTeX
@article{xu2026integrated,
title = {{Integrated rehabilitation for post-stroke anxiety: a prospective, multicenter, randomized controlled trial}},
author = {Shenglu Xu and Keqin Ye and Shiyu Zhang and Kaili Chen and Jie Zhou and Xiaohua Hu and Liping Li and Zaifu Zhang and Hong Gao},
journal = {Frontiers in Psychiatry},
year = {2026},
month = nov,
doi = {10.3389/fpsyt.2026.1985948},
url = {https://www.frontiersin.org/articles/10.3389/fpsyt.2026.1985948/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Integrated rehabilitation for post-stroke anxiety: a prospective, multicenter, randomized controlled trial
AU - Shenglu Xu
AU - Keqin Ye
AU - Shiyu Zhang
AU - Kaili Chen
AU - Jie Zhou
AU - Xiaohua Hu
AU - Liping Li
AU - Zaifu Zhang
AU - Hong Gao
PY - 2026
DA - 2026/11/06
JO - Frontiers in Psychiatry
DO - 10.3389/fpsyt.2026.1985948
UR - https://www.frontiersin.org/articles/10.3389/fpsyt.2026.1985948/full
AB - Introduction: Post-stroke anxiety (PSA) affects approximately one-quarter of stroke survivors and impedes functional recovery, yet pharmacological options remain limited by inconsistent efficacy and absent standardized guidelines. This study evaluated an integrated rehabilitation program combining repetitive transcranial magnetic stimulation (rTMS), acupuncture, and Chinese herbal medicine for PSA. Methods: In this multicenter randomized controlled trial, 188 participants with mild-to-moderate PSA were randomized 1:1 to standard care (pharmacotherapy, general care, and exercise therapy) or integrated rehabilitation (standard care plus rTMS, acupuncture, and Chinese herbal medicine) for 4 weeks, with an 8-week follow-up. The primary outcome was the Hamilton Anxiety Rating Scale (HAM-A). Secondary outcomes included the Self-Rating Anxiety Scale (SAS), Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Montreal Cognitive Assessment (MoCA), Fugl–Meyer Assessment (FMA), and Pittsburgh Sleep Quality Index (PSQI). Analyses followed an intention-to-treat framework. Results: The integrated rehabilitation group showed significantly greater reductions in HAM-A scores at Week 4 than controls (between-group difference, 2.49 points; 95% CI, 1.50 to 3.48; p <0.01), and this treatment benefit was maintained at week 12 (p<0.01). In supportive analyses of the secondary outcomes, Holm-adjusted group × time interactions remained significant for PSQI, MoCA, upper-extremity motor function, ADL, and SAS scores (all adjusted p<0.05), but not for lower-extremity motor function or IADL. Discussion: The integrated rehabilitation program improved the primary anxiety outcome and provided supportive evidence of broader clinical benefits in sleep quality, cognition, and upper-extremity motor function, together with distinct patterns of functional change in ADL and IADL. Overall, these findings support further consideration of this integrated approach as an adjunct to pharmacotherapy for PSA. Biological mechanisms and contributions of individual intervention components remain undetermined. Further mechanistic investigations incorporating biological measures would help clarify the underlying mechanisms. Clinical trial registration: https://clinicaltrials.gov/ , identifier NCT05147077.
SN - 1664-0640
ER -