Anxiety Reduction Interventions for Stroke Survivors

Overseen By Kathleen Zavotsky

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive impairment, Unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but please confirm with the research team.

What data supports the idea that Anxiety Reduction Interventions for Stroke Survivors is an effective treatment?

The available research shows that Anxiety Reduction Interventions for Stroke Survivors can be effective. For example, one study on relaxation training found it could reduce self-reported tension in stroke patients. Another study highlighted the benefits of group therapy for anxiety disorders, noting that it helps patients understand and manage their anxiety better. These findings suggest that such interventions can help stroke survivors manage anxiety effectively. ^{1 2 3 4 5}

What safety data exists for anxiety reduction treatments in stroke survivors?

The provided research does not directly address safety data for the specific treatments named (Anxiety Reduction Bundle, NYU Langone Health Anxiety Reduction Bundle, Anxiety Support Program). However, it includes studies on interventions for anxiety after stroke, such as relaxation training and group therapy, which may offer insights into the general safety and effectiveness of anxiety treatments in stroke survivors. The Cochrane Review and other studies suggest that these interventions are generally considered safe, focusing on reducing anxiety and improving psychological outcomes post-stroke. ^{1 3 4 5 6}

Is the Anxiety Reduction Bundle a promising treatment for reducing anxiety in stroke survivors?

Yes, the Anxiety Reduction Bundle is a promising treatment for reducing anxiety in stroke survivors. Research shows that group therapy and relaxation training can help manage anxiety after a stroke, making this bundle a valuable option for stroke survivors seeking relief from anxiety. ^{1 2 4 5 7}

Research Team

Bibi Sangster

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals who have recently had an acute stroke and are stable enough to be discharged home. They must be able to understand and communicate in English, not have cognitive impairments, have internet access including email, and be willing to participate in an anxiety reduction program.

Inclusion Criteria

Internet access including email

You have recently been diagnosed with a stroke.

Able to speak, read and write in English

Exclusion Criteria

Not medically stable

You have trouble thinking or remembering things.

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

Treatment Details

Interventions

• Anxiety Reduction Bundle

Trial Overview The study tests the effectiveness of the 'Anxiety Reduction Bundle' on stroke patients after they return home. Participants will use online resources and attend support groups over three months, with their anxiety levels measured before and after using a survey.

Participant Groups

Group I: Patients discharged following acute care stroke Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

The commentary aims to provide insights on the Cochrane Review regarding interventions for treating anxiety in stroke patients, highlighting the importance of addressing mental health in rehabilitation.

It emphasizes the need for effective strategies to manage anxiety post-stroke, which can significantly impact recovery and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective are treatments for anxiety after stroke? - A Cochrane Review summary with commentary. Knapp, P.[2019]

Anxiety disorders are common after a stroke, affecting 22% of patients, with phobic disorders being the most prevalent subtype, indicating a need for targeted treatment approaches.

Younger patients and those with a history of anxiety or depression are more likely to experience anxiety post-stroke, which is linked to greater dependency and poorer quality of life, highlighting the importance of addressing anxiety in stroke recovery plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety After Stroke: The Importance of Subtyping. Chun, HY., Whiteley, WN., Dennis, MS., et al.[2022]

A new group was established within the rehabilitation service to help manage patient anxieties and provide practical information, which has been positively received by patients.

Feedback indicates that these group sessions have reduced the time staff spend on individual appointments by addressing common questions, improving overall efficiency in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary approach to cardiac rehabilitation care. Hussain, F., Wooller, D.[2019]

A relaxation group protocol was successfully implemented for 55 stroke patients over 24 months, showing a significant reduction in self-reported tension after relaxation training, regardless of the number of sessions attended.

The results suggest that relaxation training could be an effective intervention for reducing anxiety symptoms in post-stroke patients, potentially improving their rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation training after stroke: potential to reduce anxiety. Kneebone, I., Walker-Samuel, N., Swanston, J., et al.[2022]

Group therapy for patients with anxiety disorders during neurorehabilitation has been effective in addressing the psychological consequences of anxiety and developing long-term coping strategies.

Over two years of experience, the use of group therapy has shown to enhance the therapeutic process, making it more efficient and beneficial for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavior therapy oriented group therapy for anxiety disorders in neurorehabilitation]. Scholz, H., Lhotka, R., Franke, R.[2015]

A structured, multidisciplinary intervention program for patients with first-ever stroke or transient ischemic attack (TIA) significantly reduced depressive symptoms one year post-stroke, with only 4.7% of patients in the intervention group experiencing depression compared to 13.5% in the control group.

The intervention also led to a statistically significant improvement in anxiety and depression scores, as measured by the Hospital Anxiety and Depression Scale (HADS), indicating that managing vascular risk factors can positively impact emotional well-being after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. Ihle-Hansen, H., Thommessen, B., Fagerland, MW., et al.[2022]

In a study of 44 stroke survivors with an average age of 68.6 years, anxiety symptoms were linked to a higher use of avoidant coping strategies, suggesting that how individuals cope with their situation can influence their anxiety levels.

Interestingly, the study found no significant connection between the time since the stroke and the level of self-reported distress, indicating that anxiety may persist regardless of recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poststroke anxiety and its relationship to coping and stage of recovery. Gillespie, DC.[2004]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

How effective are treatments for anxiety after stroke? - A Cochrane Review summary with commentary. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Anxiety After Stroke: The Importance of Subtyping. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A multidisciplinary approach to cardiac rehabilitation care. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Relaxation training after stroke: potential to reduce anxiety. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

[Behavior therapy oriented group therapy for anxiety disorders in neurorehabilitation]. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Poststroke anxiety and its relationship to coping and stage of recovery. [2004]