Stroke and Anxiety Reduction

NCT06013982 | Completed

• 1 other identifier: 23-00759
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• Change in GAD-7 Score from Baseline to 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

Study Arms (1)

Patients discharged following acute care stroke

EXPERIMENTAL

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

Interventions

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

Patients discharged following acute care stroke

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bibi Sangster

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: August 22, 2023
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)