Ischemic Stroke, AcuteBRT-StrokeNCT07731282
Benson Relaxation for Anxiety, Depression, and Insomnia After Stroke
A study testing Benson Relaxation Technique and Structured Health Education in people with Ischemic Stroke, Acute and Post-stroke Anxiety, run by Changchun University of Traditional Chinese Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Acute, Post-stroke Anxiety, Post-stroke Depression
- What is being tested?
- Benson Relaxation Technique and Structured Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 28 Jul 2026to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130000
The Third Clinical Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130000
About this study
Official title: Effects of the Benson Relaxation Technique on Anxiety, Depression, Sleep Quality and Prefrontal Cortical Function in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
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.
- Being tested
- Benson Relaxation Technique, Structured Health Education
- Keywords
- Benson Relaxation Technique, Stroke, Anxiety, Functional Near-Infrared Spectroscopy, Nursing Intervention, Randomized Controlled Trial
- Medical subject headings
- Ischemic Stroke, Stroke, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson Relaxation TechniqueBehavioural
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.
Structured Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BRT Group | Experimental | Behavioral: Benson Relaxation Technique Receives: Behavioral: Benson Relaxation Technique |
| Control Group | Active comparator | Behavioral: Structured Health Education Receives: Behavioral: Structured Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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). Scores range from 0 to 21, with higher scores indicating more severe anxiety or depression symptoms.
Measured: Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The scale ranges from 0 to 21, with higher scores indicating worse sleep quality. The scale will be administered at baseline (T0) and post-intervention (T1, day 14).
Measured: T0 and T1 (day 14)
Secondary outcomes (2)
Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke-Specific Quality of Life Scale (SS-QOL) will be used to assess quality of life. The minimum score is 0, and the maximum score is 245. Higher scores indicate a better quality of life. The scale will be administered at baseline (T0) and post-intervention (T1, day 14).
Measured: T0 and T1 (day 14)
Functional near-infrared spectroscopy (fNIRS)
Resting-state functional near-infrared spectroscopy (fNIRS) will be used to measure prefrontal brain function. Metrics include functional connectivity (FC) and amplitude of low-frequency fluctuation (ALFF). There is no minimum or maximum score. Higher values indicate stronger functional connectivity or greater local brain activity. The measurements will be acquired at baseline (T0) and post-intervention (T1, day 14).
Measured: T0 and T1 (day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start28 Jul 2026
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geng Nannan, Changchun University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731282
- Sponsor's protocol ID
- BRT-Stroke-2026-CCUCM
- Acronym
- BRT-Stroke
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Benson Relaxation Technique on Anxiety, Depression, Sleep Quality and Prefrontal Cortical Function in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07731282
- Acronym / sponsor ID
- BRT-Stroke / BRT-Stroke-2026-CCUCM
- Keywords
- Benson Relaxation Technique, Stroke, Anxiety, Functional Near-Infrared Spectroscopy, Nursing Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Changchun University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRT Group | Experimental | Behavioral: Benson Relaxation TechniqueBehavioral: Benson Relaxation Technique |
| Control Group | Active comparator | Behavioral: Structured Health EducationBehavioral: Structured Health Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benson Relaxation TechniqueA 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. | Behavioural | BRT Group |
| Structured Health EducationA 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. | Behavioural | Control Group |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
Time frame: Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)
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). Scores range from 0 to 21, with higher scores indicating more severe anxiety or depression symptoms.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: T0 and T1 (day 14)
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The scale ranges from 0 to 21, with higher scores indicating worse sleep quality. The scale will be administered at baseline (T0) and post-intervention (T1, day 14).
2 secondary outcomes
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: T0 and T1 (day 14)
Functional near-infrared spectroscopy (fNIRS)
Time frame: T0 and T1 (day 14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson Relaxation Technique and Structured Health Education in people with Ischemic Stroke, Acute and Post-stroke Anxiety, run by Changchun University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales (time frame: Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.