Benson Relaxation for Anxiety and Depression After Stroke (BRT-Stroke)
23 juli 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Beräknad)
74
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Nannan Geng
- Telefonnummer: +8618705674055
- E-post: 1509950513@qq.com
Studieorter
-
-
Jilin
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Changchun, Jilin, Kina, 130117
- Changchun University of Traditional Chinese Medicine
-
Kontakt:
- Yang Wang
- Telefonnummer: +8615567188756
- E-post: 1509950513@qq.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: Control Group
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Tidsram: T0 and T1 (day 14)
|
T0 and T1 (day 14)
|
|
Stroke-Specific Quality of Life Scale (SS-QOL)
Tidsram: T0 and T1 (day 14)
|
T0 and T1 (day 14)
|
|
Functional near-infrared spectroscopy (fNIRS)
Tidsram: T0 and T1 (day 14)
|
T0 and T1 (day 14)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
23 juli 2026
Primärt slutförande (Beräknad)
31 oktober 2026
Avslutad studie (Beräknad)
31 oktober 2026
Studieregistreringsdatum
Först inskickad
23 juli 2026
Först inskickad som uppfyllde QC-kriterierna
23 juli 2026
Första postat (Faktisk)
28 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BRT-Stroke-2026-CCUCM
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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