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Behavioral Intervention

Self-Management Intervention for Anxiety in Respiratory Failure Survivors (SMARA Trial)

N/A
Recruiting
Led By Megan Hosey, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English speaking and not aphasic
≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to evaluate a psychological intervention for anxiety in ICU patients. The goal is to see if a cognitive behavioral therapy intervention can help reduce anxiety symptoms in these patients. The study will compare patients who

Who is the study for?
This trial is for English-speaking adults over 18 who've been on a ventilator for more than a day due to acute respiratory failure (ARF) and are expected to stay in the hospital for over a week. They must be alert, not delirious, and experiencing anxiety symptoms.
What is being tested?
The study tests if cognitive behavioral therapy-based self-management can reduce anxiety in ICU patients with ARF. It compares outcomes of this intervention against usual care immediately after treatment and at three months follow-up.
What are the potential side effects?
Since the intervention involves psychological therapy rather than medication, traditional side effects are minimal but may include discomfort discussing personal issues or temporary increases in distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak English and do not have difficulty with speech.
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I am 18 years old or older.
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I have been on a breathing machine through a tube for more than 24 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment Satisfaction Questionnaire
average accrual rate of 2 patients/month across all patients
treatment feasibility as assessed by drop out rate
+1 more
Secondary study objectives
Healthcare Utilization as assessed by Healthcare Utilization interview
Hopkins Rehab Engagement Scale
Hospital Anxiety and Depression Scale
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Self-management interventionExperimental Treatment1 Intervention
Cognitive behavioral therapy based self-management intervention for anxiety
Group II: Usual CareActive Control1 Intervention
Usual hospital-based care

Find a Location

Who is running the clinical trial?

Francis Family FoundationOTHER
1 Previous Clinical Trials
34 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,750 Total Patients Enrolled
16 Trials studying Anxiety
4,069 Patients Enrolled for Anxiety
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,271 Total Patients Enrolled
1 Trials studying Anxiety
190 Patients Enrolled for Anxiety
~40 spots leftby Feb 2027
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