An interventional study of Cognitive behavioral therapy based self-management for anxiety in Respiratory Failure, Anxiety and Critical Illness, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.
The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.
The main question[s] it aims to answer are:
Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.
Statement of the Problem. An increasing number of adults develop acute respiratory failure (ARF) requiring mechanical ventilation in an intensive care unit (ICU). To improve patient outcomes, evidence-based guidelines recommend titrating sedatives to allow for patient wakefulness while in the ICU. However, among awake acute respiratory failure patients, anxiety can be a common and long-lasting problem. Outside of the ICU setting, cognitive behavioral therapy based self-management is an established, evidence-based, first-line treatment for patients with anxiety. However, there is limited evidence about the feasibility and benefit of cognitive behavioral therapy interventions for acute respiratory failure patients with anxiety during hospitalization.
Specific Aims. This award proposal seeks to conduct a pilot randomized controlled trial of a tailored self-management protocol vs. usual care in the ICU and subsequent hospital ward to establish its feasibility, acceptability (primary outcome; Aim 1a), and potential efficacy in reducing anxiety symptoms and associated outcomes at hospital discharge (Aim 1b) and at 3-month follow-up (secondary outcomes; Aim 2). Experimental Approach. Pilot randomized controlled trial with blinded outcome assessment and 3-month phone-based follow-up.
Significance of the results. ARF patients experience significant anxiety during ICU stay, reporting feelings of terror, fear of death, and loss of control. Up to 50% of ARF patients report clinically significant anxiety at ICU discharge, and up to 40% report persistent symptoms up to 5 years after ICU. This project provides an essential foundation for evaluating a novel intervention, with a strong evidence-base outside of the ICU, to reduce anxiety in acute respiratory failure patients.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cognitive behavioral therapy based self-management intervention for anxiety
Behavioral: Cognitive behavioral therapy based self-management for anxiety
Usual hospital-based care
Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.
Also known as: SMARA
Treatment Satisfaction Questionnaire
Treatment Satisfaction Questionnaire (TSQ) ranges from 0-21, with higher scores representing greater satisfaction. Items (e.g., "useful", "liked it," "perceived symptom improvement") are scored based on a Likert scale, ranging from 0= "not at all" to 7= "very much so." Higher scores indicate higher satisfaction
Time frame: 5 weeks post-enrollment
average accrual rate of 2 patients/month across all patients
treatment feasibility objective
Time frame: 3 years
treatment feasibility as assessed by sessions completed
treatment feasibility as assessed by \>70% of intervention sessions completed
Time frame: 5 weeks post enrollment
treatment feasibility as assessed by drop out rate
treatment feasibility as assessed by \<15% drop-out across intervention arm
Time frame: 3 years
Visual Analog Scale - Anxiety
the 100 mm Visual Analog Scale for Anxiety (VAS-A.) Scores range from "not anxious at all" (0 mm) to "the most anxious I have ever felt" (100 mm).
Time frame: at hospital discharge (up to 12 weeks after randomization), 5 weeks post enrollment, 3 months
State Anxiety Inventory
The State Anxiety Inventory (SAI) is a 6 -item, abbreviated version of the original State Trait Anxiety Inventory, validated in ARF patients. The SAI assesses current emotional state using a Likert scale ranging from 1 "not at all" to 4 "very much," has a range of 0-24, and has been validated in ARF patients in the ICU. Higher score, higher anxiety.
Time frame: at hospital discharge (up to 12 weeks after randomization), immediately post intervention, 5 weeks post intervention, 3 months
Hopkins Rehab Engagement Scale
The Hopkins Rehabilitation Engagement Scale 5-item scale for use in rating behavioral observations of patients during acute inpatient rehabilitation. Score ranges from 5 to 30 with higher scores representing better rehabilitation engagement.
Time frame: at hospital discharge (up to 12 weeks after randomization)
Self Efficacy for Managing Chronic Disease Rating Scale
The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Total scores range from 10-60. Higher scores represent greater confidence to manage chronic disease.
Time frame: at hospital discharge (up to 12 weeks after randomization), 3 month followup
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS)is a 14-item measure with a likert response scale 0 "not at all" to 3 (stem varies). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores suggest higher depression or anxiety symptoms.
Time frame: at hospital discharge (up to 12 weeks after randomization), 3 month followup
Quality of Life as assessed by the European Quality of Life Scale (EQ-5D)
European Quality of Life Scale, part of the NHLBI Core Outcome Measure Set for ARF survivors. The EQ-5D is a 6-item health-related quality of life measure recommended for use with ICU survivors. It provides utility estimates with US norms. Index scores range from -0.59 to 1, where 1 suggests better health state.
Time frame: 3 month follow up
Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6
Impact of Event Scale - 6 item (IES-6) is a post-traumatic stress disorder symptom measure, part of the NHLBI Core Outcome Measure Set for ARF survivors. Higher scores indicate more PTSD symptoms. Score range is 0-24.
Time frame: 3 month follow up
Healthcare Utilization as assessed by Healthcare Utilization interview
The Healthcare Utilization Survey (HUS) is a structured interview assessing hospitalizations, nursing facility stays, rehabilitation facility stays, as well as number and type of outpatient provider visits.
Time frame: 3 month follow-up
Montreal Cognitive Assessment - Blind
cognitive screen, part of the NHLBI Core Outcome Measure Set for ARF survivors The Montreal Cognitive Assessment - Blind (MOCA) is a 13-item cognitive screening instrument. Higher scores are better. Possible range = 0- 30
Time frame: 3 month follow up
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University