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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2027-09-01

Brief Summary

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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.

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Detailed Description

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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

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Respiratory Failure Anxiety Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pilot randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-management intervention

Cognitive behavioral therapy based self-management intervention for anxiety

Group Type EXPERIMENTAL

Cognitive behavioral therapy based self-management for anxiety

Intervention Type BEHAVIORAL

Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.

Usual Care

Usual hospital-based care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive behavioral therapy based self-management for anxiety

Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.

Intervention Type BEHAVIORAL

Other Intervention Names

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SMARA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes