Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention (SMARA)

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:

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Respiratory Failure; Anxiety
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy based self-management for anxiety

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Hosey, PhD; Phone Number: 410-502-2429; Email: mhosey@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥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)**

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-management intervention; Cognitive behavioral therapy based self-management intervention for anxiety	Behavioral: Cognitive behavioral therapy based self-management for anxiety; Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.; Other Names: SMARA
No Intervention: Usual Care; Usual hospital-based care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 weeks post-enrollment
average accrual rate of 2 patients/month across all patients	treatment feasibility objective	3 years
treatment feasibility as assessed by sessions completed	treatment feasibility as assessed by >70% of intervention sessions completed	5 weeks post enrollment
treatment feasibility as assessed by drop out rate	treatment feasibility as assessed by <15% drop-out across intervention arm	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	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.	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	3 month follow up

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Francis Family Foundation
• Investigators: Principal Investigator: Megan Hosey, PhD, Johns Hopkins School of Medicine

Publications and helpful links

General Publications

• Chlan 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.
• 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.
• Hosey 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: IRB00247005; K23HL155735 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No