Benson Relaxation for Anxiety, Depression, and Insomnia After Stroke

NCT07731282 | Completed DMC

• 1 other identifier: BRT-Stroke-2026-CCUCM
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sleep; Ischemic Stroke, Acute; Post-stroke Anxiety; Post-stroke Depression

Keywords

Benson Relaxation Technique; Stroke; Anxiety; Functional Near-Infrared Spectroscopy; Nursing Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  T0 and T1 (day 14)

Secondary Outcomes (2)

• 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

EXPERIMENTAL

Behavioral: Benson Relaxation Technique

Behavioral: Benson Relaxation Technique

Control Group

ACTIVE COMPARATOR

Behavioral: Structured Health Education

Behavioral: Structured Health Education

Interventions

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.

BRT Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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.

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
• 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

Sponsors & Collaborators

• Changchun University of Traditional Chinese Medicine: lead

Study Sites (2)

The Affiliated Hospital of Changchun University of Chinese Medicine

Changchun, Jilin, 130000, China

Location

The Third Clinical Hospital of Changchun University of Chinese Medicine

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

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: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student Researcher

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 28, 2026
• Primary Completion: September 23, 2026
• Study Completion: September 23, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)