Benson Relaxation for Anxiety and Depression After Stroke (BRT-Stroke)
23. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Antatt)
74
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Nannan Geng
- Telefonnummer: +8618705674055
- E-post: 1509950513@qq.com
Studiesteder
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Jilin
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Changchun, Jilin, Kina, 130117
- Changchun University of Traditional Chinese Medicine
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Ta kontakt med:
- Yang Wang
- Telefonnummer: +8615567188756
- E-post: 1509950513@qq.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BRT Group
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.
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Aktiv komparator: Control Group
Behavioral: Structured Health Education
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
Tidsramme: 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).
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Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: T0 and T1 (day 14)
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T0 and T1 (day 14)
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Stroke-Specific Quality of Life Scale (SS-QOL)
Tidsramme: T0 and T1 (day 14)
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T0 and T1 (day 14)
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Functional near-infrared spectroscopy (fNIRS)
Tidsramme: T0 and T1 (day 14)
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T0 and T1 (day 14)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
23. juli 2026
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
31. oktober 2026
Datoer for studieregistrering
Først innsendt
23. juli 2026
Først innsendt som oppfylte QC-kriteriene
23. juli 2026
Først lagt ut (Faktiske)
28. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BRT-Stroke-2026-CCUCM
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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