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

Johns Hopkins University

Status

Enrolling

Conditions

Respiratory Failure

Critical Illness

Anxiety

Treatments

Behavioral: Cognitive behavioral therapy based self-management for anxiety

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06341972

K23HL155735 (U.S. NIH Grant/Contract)

IRB00247005

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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