NCT07731282Completed
Benson Relaxation for Anxiety, Depression, and Insomnia After Stroke
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 23 Jul 2026
- Start date
- 28 Jul 2026
- Primary completion date
- 23 Sept 2026
- Lead sponsor
- Changchun University of Traditional Chinese Medicine
- Diseases
- Stroke
- NCT number
- NCT07731282
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 28 Jul 2026 to the primary completion date, 23 Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Combined with severe aphasia, visual and auditory impairments, unable to cooperate with intervention and assessment
- Is currently participating in other clinical intervention studies
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Changchun University of Chinese Medicine Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Clinical Hospital of Changchun University of Chinese Medicine Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.