Stroke and Anxiety Reduction

The purpose of this pilot study is to explore the impact that a structured anxiety reduction intervention program has on patients being discharged to home following an acute stroke in an academic medical center. Eligible participants will be screened and recruited by the research team through daily rounds. After completing the informed consent process, the research team will pull demographic information from the electronic health record (EHR) and REDCAP that includes ethnicity and support system. Participants will complete the Anxiety Screen Questionnaire (GAD-7 ANXIETY SURVEY) and will be provided with information regarding stroke support groups available with additional NYU Langone Health and the American Heart Association internet-based information regarding anxiety reduction (NYU Langone Health Anxiety Reduction Bundle). The participants will be encouraged to attend a stroke support group for 3 months and utilize the NYU Langone Health Anxiety Reduction Bundle provided. At the completion of the intervention (3 months), participants will be provided with the GAD-7 ANXIETY SURVEY again and a survey that includes open-ended questions and a program evaluation by email. Analysis will occur after final data is collected.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Be diagnosed with an acute stroke
Able to speak, read and write in English
Not cognitively impaired, as per standard of care documentation in the EHR regarding mental status.
Discharged to home
Internet access including email
Willingness to participate in an anxiety reduction program
Length of hospital stay less than 5 days from the initial presentation of stroke symptoms
Must be medically stable

Exclusion criteria

Not diagnosed with an acute stroke
Unable to speak, read and write in English as this intervention is not available in other languages and at this time, funding is not available in order to have the resources provided translated or to have translation services available for these participants.
Not discharged to home
No internet access including email
Unwilling or unable to participate in an anxiety reduction program
Cognitively impaired
Length of hospital stay greater than 6 days from the initial presentation of stroke symptoms
Not medically stable

Treatment and study plan

Anxiety Reduction Bundle

Behavioral

The Anxiety Reduction Bundle intervention comprises the following resources:

Stroke Support Group
Anxiety Reduction Sheet
Understanding Anxiety Disorder sheet
Your body's response to anxiety sheet
Relaxation Tip sheet
Breathing Tip sheet and video
A sigh of Relief video

Primary outcomes

Change in GAD-7 Score from Baseline to Month 3

Time frame: Baseline, Month 3

The GAD-7 Anxiety Questionnaire involves 7 items assessing how often participants have felt bothered by anxiety-related problems over the past two weeks. Each item is rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; where 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Impact of a Structured Anxiety Reduction Program on Anxiety in Patients Who Are Discharged to Home Following an Acute Stroke in an Academic Medical Center

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Aug 28, 2023
Registry last updated: Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed