Respiratory FailureSMARANCT06341972
Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
A study testing Cognitive behavioral therapy based self-management for anxiety in people with Respiratory Failure and Anxiety, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Anxiety, Critical Illness
- What is being tested?
- Cognitive behavioral therapy based self-management for anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 1 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- English speaking and not aphasic
- ARF with mechanical ventilation via endotracheal tube > 24 hours
- Expected hospital stay of >7 days at time of eligibility
- Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)
- Not delirious (ie, negative Confusion Assessment Method -ICU score)
- Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)**
Who cannot join
- Pre-existing cognitive impairment (AD-8 score ≥2)
- History of major psychiatric illness (i.e., psychotic disorder, bi-polar disorder, suicide attempt in past 24 months, pervasive developmental disorder, active substance use disorder)
- Declines or incapable of informed consent
- Anticipated discharge to hospice, primary focus on palliative care, or >90% probability of in-hospital death
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Megan Hosey, 410-502-2429, hmegan1@jhmi.edu
hmegan1@jhmi.edu
About this study
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.
Read more
The main question[s] it aims to answer are:
- Is this intervention feasible and acceptable in ARF patients?
- Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?
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.
Read the detailed description
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.
- Conditions
- Respiratory Failure, Anxiety, Critical Illness
- Being tested
- Cognitive behavioral therapy based self-management for anxiety
- Medical subject headings
- Respiratory Insufficiency, Anxiety Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy based self-management for anxietyBehavioural
Also called SMARA
Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.
| Study group | Role | What they receive |
|---|---|---|
| Self-management intervention | Experimental | Cognitive behavioral therapy based self-management intervention for anxiety Receives: Behavioral: Cognitive behavioral therapy based self-management for anxiety |
| Usual Care | No intervention | Usual hospital-based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 weeks post-enrollment
average accrual rate of 2 patients/month across all patients
treatment feasibility objective
Measured: 3 years
treatment feasibility as assessed by sessions completed
treatment feasibility as assessed by >70% of intervention sessions completed
Measured: 5 weeks post enrollment
treatment feasibility as assessed by drop out rate
treatment feasibility as assessed by <15% drop-out across intervention arm
Measured: 3 years
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start31 May 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Francis Family Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Megan Hosey, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341972
- Sponsor's protocol ID
- IRB00247005
- Other IDs
- K23HL155735
- Acronym
- SMARA
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
May AD, Parker AM, Caldwell ES, Hough CL, Jutte JE, Gonzalez MS, Needham DM, Hosey MM. Provider-Documented Anxiety in the ICU: Prevalence, Risk Factors, and Associated Patient Outcomes. J Intensive Care Med. 2021 Dec;36(12):1424-1430. doi: 10.1177/0885066620956564. Epub 2020 Oct 9.
PubMed 33034254Hosey MM, Wegener ST, Hinkle C, Needham DM. A Cognitive Behavioral Therapy-Informed Self-Management Program for Acute Respiratory Failure Survivors: A Feasibility Study. J Clin Med. 2021 Feb 20;10(4):872. doi: 10.3390/jcm10040872.
PubMed 33672672Chlan L, Savik K. Patterns of anxiety in critically ill patients receiving mechanical ventilatory support. Nurs Res. 2011 May-Jun;60(3 Suppl):S50-7. doi: 10.1097/NNR.0b013e318216009c.
PubMed 21543962