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Completed
NCT07731282
Benson Relaxation for Anxiety, Depression, and Insomnia After Stroke
Conditions: Ischemic Stroke, Acute, Post-stroke Anxiety, Post-stroke Depression, Sleep
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 84
Sponsor: Changchun University of Traditional Chinese Medicine
Location: The Affiliated Hospital of Changchun University of Chinese Medicine Changchun Jilin
Summary
Stroke is a leading cause of disability worldwide. Many patients experience anxiety, depression, and sleep disturbances in the early recovery phase, which can slow rehabilitation. Medications for mood symptoms may have side effects, especially in acute stroke patients. Benson Relaxation Technique (BRT) is a non-pharmacological mind-body intervention involving breathing exercises, muscle relaxation, and guided imagery.This multicenter, assessor-blinded, randomized controlled trial aims to evaluate the short-term effects of BRT on anxiety, depression, sleep quality, quality of life, and prefrontal brain function in patients 7-14 days after ischemic stroke. A total of 84 participants will be randomly assigned (1:1) to either the BRT group or a structured health education active control group. Interventions will be delivered twice daily for 20 minutes over 14 days.Outcomes will be assessed at baseline (T0) and post-intervention (T1, day 14). Assuming a 10-12% dropout rate, approximately 10 participants will withdraw, leaving 74 participants (37 per group) to complete the study and be included in the final analysis. The primary outcomes are the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include the Stroke-Specific Quality of Life Scale (SS-QOL) and resting-state functional near-infrared spectroscopy (fNIRS) metrics.
Eligibility Criteria
Inclusion Criteria:
* Meets the diagnostic criteria for stroke set by the Neurology Branch of the Chinese Medical Association, and is confirmed as ischemic stroke based on CT or MRI examination results.
* In the acute stage of stroke (7-14 days after onset)
* Age ≥ 18 years old
* Clear consciousness, stable condition, and able to communicate effectively
* Hospital Anxiety and Depression Scale (HADS) score: HADS-A ≥ 8 points or HADS-D ≥ 8 points (or both ≥ 8 points)
* Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
* Combined with severe aphasia, visual and auditory impairments, unable to cooperate with intervention and assessment
* Combined with severe dysfunction of organs such as the heart, liver, and kidneys or malignant tumors
* Has a clear history of mental illness or has been taking anti-psychotic drugs for a long time
* Is currently participating in other clinical intervention studies
Source: ClinicalTrials.gov (NCT07731282). StuddyBuddy aggregates publicly available trial information.