Clinical trial NCT06341972: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
Official title: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Anxiety
Critical Illness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Francis Family Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Satisfaction Questionnaire
timeFrame: 5 weeks post-enrollment
measure: average accrual rate of 2 patients/month across all patients
timeFrame: 3 years
measure: treatment feasibility as assessed by sessions completed
timeFrame: 5 weeks post enrollment
measure: treatment feasibility as assessed by drop out rate
timeFrame: 3 years
Secondary outcomes:
measure: Visual Analog Scale - Anxiety
timeFrame: at hospital discharge (up to 12 weeks after randomization), 5 weeks post enrollment, 3 months
measure: State Anxiety Inventory
timeFrame: at hospital discharge (up to 12 weeks after randomization), immediately post intervention, 5 weeks post intervention, 3 months
measure: Hopkins Rehab Engagement Scale
timeFrame: at hospital discharge (up to 12 weeks after randomization)
measure: Self Efficacy for Managing Chronic Disease Rating Scale
timeFrame: at hospital discharge (up to 12 weeks after randomization), 3 month followup
measure: Hospital Anxiety and Depression Scale
timeFrame: at hospital discharge (up to 12 weeks after randomization), 3 month followup
measure: Quality of Life as assessed by the European Quality of Life Scale (EQ-5D)
timeFrame: 3 month follow up
measure: Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6
timeFrame: 3 month follow up
measure: Healthcare Utilization as assessed by Healthcare Utilization interview
timeFrame: 3 month follow-up
measure: Montreal Cognitive Assessment - Blind
timeFrame: 3 month follow up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Megan Hosey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.