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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to reduce anxiety in individuals who have recently experienced a stroke and are returning home. Participants will use a special Anxiety Reduction Bundle, which includes information and support from NYU Langone Health and the American Heart Association, for three months. The researchers aim to determine if this program can lower anxiety levels in stroke survivors. Individuals who have had a stroke, are returning home, and have internet access might be suitable for this trial. As an unphased trial, participants can contribute to innovative research that may enhance anxiety management for stroke survivors.

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 prior data suggests that this anxiety reduction intervention program is safe for stroke survivors?

Research shows that structured programs to reduce anxiety are generally easy for participants to handle. Studies have found that these programs, like the Anxiety Reduction Bundle under study, can lower anxiety without causing major side effects. These programs usually include helpful resources and support, such as support groups and information packets, to manage anxiety effectively.

While detailed safety data specifically for this bundle is not available, similar anxiety programs have a good safety record. They use non-invasive methods, meaning they don't involve medications or medical procedures that might cause side effects. Participants often report feeling better and less anxious, with few or no negative experiences.

Considering this, joining a trial for an Anxiety Reduction Bundle is likely safe for most people, especially since it doesn't involve new drugs or invasive techniques. Those considering participation should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Anxiety Reduction Bundle for stroke survivors because it takes a comprehensive approach, combining multiple techniques to specifically address anxiety in this group. Unlike standard treatments that might focus solely on medication or therapy, this bundle provides a structured program that includes personalized interventions tailored to the needs of stroke survivors. This holistic method not only aims to reduce anxiety effectively but also allows for a more thorough understanding of the patient's experience and outcomes through qualitative feedback.

What evidence suggests that the Anxiety Reduction Bundle is effective for reducing anxiety in stroke survivors?

Research has shown that organized programs to reduce anxiety effectively lower anxiety levels. These programs often include activities like mindfulness and stress education, which help ease anxiety symptoms. In this trial, participants will engage in the Anxiety Reduction Bundle, designed to help stroke survivors feel less anxious and improve their quality of life. Participants in similar past programs reported feeling less anxious and more supported. While individual experiences may vary, these programs consistently aim to reduce anxiety. ^{2 3 5 6 7}

Who Is on the Research Team?

Bibi Sangster

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive a structured anxiety reduction intervention program and are encouraged to attend a stroke support group and utilize the NYU Langone Health Anxiety Reduction Bundle

12 weeks

1 visit (in-person) for initial assessment, ongoing virtual support

Follow-up

Participants are monitored for changes in anxiety levels using the GAD-7 Anxiety Questionnaire and complete a program evaluation survey

4 weeks

1 visit (virtual) for final assessment

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. med.nyu.edu med.nyu.edu/departments-institutes/psychiatry/research/anxiety-stress-prolonged-grief

Anxiety, Stress & Prolonged Grief Research The purpose of this research study is to understand how mindfulness-based stress reduction (MBSR) compares to a stress education (SE) class in the brain of ...

2. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2484/impact-structured-anxiety-reduction/

Impact of A Structured Anxiety Reduction ... - Clinical Trials The purpose of this research study is to determine if participating in a structured anxiety reduction program helps to decrease your experience of anxiety ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10667323/

Effectiveness of a family-based program for post-stroke ... The study findings suggest that the present family-based program improved family function in family caregivers and family members and decreased caregiver burden ...

4. nyulangone.org nyulangone.org/conditions/anxiety-disorders/support

Recovery & Support for Anxiety Disorders Specialists at NYU Langone's Mood Disorders Consultation Service offer ongoing care for people with all types of anxiety disorders.

5. mentalhealth.networkofcare.org mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT06013982?keyword=%22Acute%20Stroke%22

Lake Clinical Trial 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 ...

6. trialx.com trialx.com/clinical-trials/listings/254460/stroke-and-anxiety-reduction/?&radius=50

Stroke and Anxiety Reduction | Clinical Research Trial ... The purpose of this pilot study is to explore the impact that a structured anxiety reduction intervention program has on patients being ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7345612/

Development of a Care Bundle for Stroke Survivors with ... Psychological symptoms such as depression and anxiety are quite common among stroke survivors and have great negative impacts on patients.