Benson Relaxation for Anxiety and Depression After Stroke
BRT-Stroke
Short-term Effects of Benson Relaxation Technique on Anxiety, Depression, and Prefrontal Cortical Function in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
1 other identifier
interventional
74
1 country
1
Brief Summary
This study tests whether Benson Relaxation Technique (BRT), a simple mind-body relaxation method, can help reduce anxiety and depression in patients who had an ischemic stroke 7-14 days ago. Patients will be randomly assigned to either the BRT group (receiving 20-minute relaxation sessions twice daily for 2 weeks) or a control group (receiving health education sessions of the same duration). We will measure anxiety and depression using standard questionnaires, and use near-infrared brain imaging to see if BRT changes brain activity in the prefrontal cortex. The goal is to find a safe, non-drug way to improve mood in early stroke recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2026
CompletedStudy Start
First participant enrolled
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
July 28, 2026
July 1, 2026
3 months
July 23, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
The Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety (HADS-A, 7 items, 0-21 points) and depression (HADS-D, 7 items, 0-21 points). A score ≥8 on either subscale indicates clinically significant symptoms. The scale will be administered by a blinded assessor at baseline (T0) and post-intervention (T1, day 14).
Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)
Secondary Outcomes (3)
Pittsburgh Sleep Quality Index (PSQI)
T0 and T1 (day 14)
Stroke-Specific Quality of Life Scale (SS-QOL)
T0 and T1 (day 14)
Functional near-infrared spectroscopy (fNIRS)
T0 and T1 (day 14)
Study Arms (2)
BRT Group
EXPERIMENTALBehavioral: Benson Relaxation Technique
Control Group
ACTIVE COMPARATORBehavioral: Structured Health Education
Interventions
A 20-minute mind-body relaxation session including environment preparation, breathing regulation, systematic muscle relaxation, and guided imagery, delivered twice daily for 14 days by trained nurses at the bedside.
A 20-minute structured health education session covering stroke rehabilitation knowledge, diet guidance, medication adherence, and emotional management, delivered twice daily for 14 days by nurses at the bedside, matched in frequency and duration to the BRT group.
Eligibility Criteria
You may qualify if:
- 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) ③ Age ≥ 18 years old ④ Clear consciousness, stable condition, and able to communicate effectively ⑤ Hospital Anxiety and Depression Scale (HADS) score: HADS-A ≥ 8 points or HADS-D ≥ 8 points (or both ≥ 8 points) ⑥ Voluntarily participate in this study and sign the informed consent form.
You may not qualify if:
- 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 ③ Has a clear history of mental illness or has been taking anti-psychotic drugs for a long time ④ Is currently participating in other clinical intervention studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geng Nannanlead
Study Sites (1)
Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130117, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 28, 2026
Study Start
July 23, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made publicly available due to ethical restrictions and patient privacy protections for acute stroke survivors. The study involves sensitive psychological and neuroimaging data that could potentially identify participants. De-identified group-level statistical results and summary datasets may be made available upon reasonable request to the corresponding author, subject to approval by the institutional ethics committee.