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NCT Number: NCT07731282

Benson Relaxation for Anxiety and Depression After Stroke

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.

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Key information

Conditions

Ischemic Stroke, Acute Anxiety Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Mental Disorders Nervous System Diseases Post-stroke Anxiety Post-stroke Depression Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benson Relaxation Technique

Behavioral

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 Education

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: T0 and T1 (day 14)

  2. Stroke-Specific Quality of Life Scale (SS-QOL)

    Time frame: T0 and T1 (day 14)

  3. Functional near-infrared spectroscopy (fNIRS)

    Time frame: T0 and T1 (day 14)

Study contacts

Contact information is provided by the study sponsor or research team.

Nannan Geng

CONTACT

[email protected]

+8618705674055

Sponsors and collaborators

Lead sponsor

Geng Nannan

Other

Registry information

Official study title

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

Acronym: BRT-Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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