Morning Activation to Improve Mood After Stroke
17. juli 2026 oppdatert av: Prof. LAU Chun Lun Stephen, The Hong Kong Polytechnic University
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking.
Participants will be randomly assigned to either the behavioral intervention or a health education program. Assessments will be completed before and immediately after the six-week program and will include questionnaires and seven-day monitoring of sleep, activity, and mood. The study will also examine feasibility indices such as participant retention, intervention attendance, acceptability, and preliminary changes in mood.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
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: Stephen Lau
- Telefonnummer: +852 2766 4283
- E-post: chun-lun-stephen.lau@polyu.edu.hk
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- The Hong Kong Polytechnic University
-
Ta kontakt med:
- Stephen Lau
- Telefonnummer: +852 2766 4283
- E-post: chun-lun-stephen.lau@polyu.edu.hk
-
Hovedetterforsker:
- Stephen Lau, PhD
-
-
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
Nei
Beskrivelse
Inclusion Criteria:
- Age 18 years or older.
- History of stroke at least 6 months before enrollment.
- Patient Health Questionnaire-9 score of 10 or higher.
- Difficulty getting started or engaging in activities in the morning.
- Able to provide informed consent.
Exclusion Criteria:
- Conditions that would interfere with study participation.
- Neurological condition other than stroke.
- Currently receiving psychological therapy for depression.
- Significant cognitive impairment or dementia.
- Current or past diagnosis of psychosis, bipolar disorder, or mania.
- Hospitalization that would interfere with study participation.
- Acute or significant suicidal ideation
- Alcohol or substance use problems within the past month.
- Use of antidepressant or anti-anxiety medication unless the dosage has been stable for at least 4 weeks and no changes are planned during the study.
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: Morning Activation Program
Participants will receive a six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes.
The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke.
|
A six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes.
The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke.
Sessions will be tailored to participants' needs and abilities.
|
|
Aktiv komparator: Health Education Program
Participants will receive a six-week health education program delivered in weekly sessions of approximately 60 minutes.
The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration.
It will not include the individualized behavioral strategies provided in the experimental arm.
|
A six-week health education program delivered in weekly sessions of approximately 60 minutes.
The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration.
It will not include the individualized behavioral strategies provided in the experimental arm.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment Rate
Tidsramme: From the start of recruitment until enrollment of the final participant.
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Number of participants enrolled divided by the number of months of active recruitment.
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From the start of recruitment until enrollment of the final participant.
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Retention Rate
Tidsramme: Immediately after completion of the 6-week intervention
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Number of randomized participants who complete the immediate post-intervention assessment divided by the total number randomized, expressed as a percentage.
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Immediately after completion of the 6-week intervention
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Intervention Attendance
Tidsramme: Throughout the 6-week intervention period
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Number and percentage of scheduled intervention or health education sessions attended by each participant during the 6-week program.
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Throughout the 6-week intervention period
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Intervention Acceptability
Tidsramme: Immediately after completion of the 6-week intervention
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Acceptability of the assigned program assessed using the 4-item Acceptability of Intervention Measure.
Each item is rated from 1 to 5, producing a total score ranging from 4 to 20.
Higher scores indicate greater intervention acceptability.
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Immediately after completion of the 6-week intervention
|
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Participants Experiencing Adverse Events
Tidsramme: From enrollment through completion of the immediate post-intervention assessment.
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Number of adverse events considered related or possibly related to study participation.
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From enrollment through completion of the immediate post-intervention assessment.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Depressive Symptoms
Tidsramme: Baseline and immediately after completion of the 6-week intervention
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Depressive symptom severity assessed using the 9-item Patient Health Questionnaire-9.
Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
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Baseline and immediately after completion of the 6-week intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Faktiske)
15. mai 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
17. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSEARS20260321001
Plan for individuelle deltakerdata (IPD)
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