Benson Relaxation for Anxiety and Depression After Stroke (BRT-Stroke)

July 23, 2026 updated by: Geng Nannan

Short-term Effects of Benson Relaxation Technique on Anxiety, Depression, and Prefrontal Cortical Function in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is a leading cause of disability worldwide. Many patients experience anxiety and depression 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 single-center, 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 74 participants will be randomly assigned to either the BRT group or a structured health education 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). Primary outcomes are anxiety and depression scores (HADS). Secondary outcomes include sleep quality (PSQI), stroke-specific quality of life (SS-QOL), and resting-state prefrontal functional connectivity measured by functional near-infrared spectroscopy (fNIRS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130117
        • Changchun University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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) 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.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BRT Group
Behavioral: Benson Relaxation Technique
Behavioral: Benson Relaxation Technique
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.
Active Comparator: Control Group
Behavioral: Structured Health Education
Behavioral: Structured Health Education
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: T0 and T1 (day 14)
T0 and T1 (day 14)
Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: T0 and T1 (day 14)
T0 and T1 (day 14)
Functional near-infrared spectroscopy (fNIRS)
Time Frame: T0 and T1 (day 14)
T0 and T1 (day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geng Nannan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRT-Stroke-2026-CCUCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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