Stroke and Anxiety Reduction

NCT ID: NCT06013982

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2025-01-23

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Anxiety Reduction Bundle

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bibi Sangster

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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23-00759

Identifier Type: -

Identifier Source: org_study_id

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