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

NCT06341972 | Recruiting DMC

• 2 other identifiers: IRB00247005K23HL155735
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Anxiety; Critical Illness

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Visual Analog Scale - Anxiety

  at hospital discharge (up to 12 weeks after randomization), 5 weeks post enrollment, 3 months

• State Anxiety Inventory

  at hospital discharge (up to 12 weeks after randomization), immediately post intervention, 5 weeks post intervention, 3 months

• Hopkins Rehab Engagement Scale

  at hospital discharge (up to 12 weeks after randomization)

• Self Efficacy for Managing Chronic Disease Rating Scale

  at hospital discharge (up to 12 weeks after randomization), 3 month followup

• Hospital Anxiety and Depression Scale

  at hospital discharge (up to 12 weeks after randomization), 3 month followup

Study Arms (2)

Self-management intervention

EXPERIMENTAL

Cognitive behavioral therapy based self-management intervention for anxiety

Behavioral: Cognitive behavioral therapy based self-management for anxiety

Usual Care

NO INTERVENTION

Usual hospital-based care

Interventions

Cognitive behavioral therapy based self-management for anxiety BEHAVIORAL

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

Also known as: SMARA

Self-management intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)\*\*

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Francis Family Foundation: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 33034254 BACKGROUND

• 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.

  PMID: 33672672 BACKGROUND

• 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.

  PMID: 21543962 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Anxiety Disorders; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Hosey, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Hosey, PhD

CONTACT

410-502-2429; mhosey@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot randomized controlled trial

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 2, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)