Morning Activation to Improve Mood After Stroke
17 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Stephen Lau
- Telefoonnummer: +852 2766 4283
- E-mail: chun-lun-stephen.lau@polyu.edu.hk
Studie Locaties
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Hong Kong, Hongkong
- Werving
- The Hong Kong Polytechnic University
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Contact:
- Stephen Lau
- Telefoonnummer: +852 2766 4283
- E-mail: chun-lun-stephen.lau@polyu.edu.hk
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Hoofdonderzoeker:
- Stephen Lau, PhD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Recruitment Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Depressive Symptoms
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 mei 2026
Primaire voltooiing (Geschat)
1 december 2026
Studie voltooiing (Geschat)
1 december 2026
Studieregistratiedata
Eerst ingediend
17 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juli 2026
Eerst geplaatst (Werkelijk)
22 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
17 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HSEARS20260321001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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