Stroke and Anxiety Reduction

April 17, 2025 updated by: NYU Langone Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients discharged following acute care stroke
Participation will last 3 months from enrollment. Demographic data will be retrieved from the electronic health record and the Generalized Anxiety Disorder-7 (GAD-7) Anxiety Questionnaire will be administered at baseline. Participants will repeat the GAD-7 in 3 months and an additional qualitative survey on their experience including an evaluation of the structured anxiety reduction program.
Behavioral: Anxiety Reduction Bundle

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Bibi Sangster, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Actual)

January 23, 2025

Study Completion (Actual)

January 23, 2025

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-00759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a pilot study and the data will need to be evaluated before it is shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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