Morning Activation to Improve Mood After Stroke
NCT07719517
Summary
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.
Eligibility
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.
Conditions3
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NCT07719517