Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive behavioral therapy based self-management for anxiety
BehavioralEvidenced based approach for educating patients about how to manage anxiety after respiratory failure.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Self-management interventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
5 weeks post-enrollment2
average accrual rate of 2 patients/month across all patients
treatment feasibility objective
Time frame
3 years3
treatment feasibility as assessed by sessions completed
treatment feasibility as assessed by \>70% of intervention sessions completed
Time frame
5 weeks post enrollment4
treatment feasibility as assessed by drop out rate
treatment feasibility as assessed by \<15% drop-out across intervention arm
Time frame
3 yearsSecondary outcomes
1
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).
Time frame
at hospital discharge (up to 12 weeks after randomization), 5 weeks post enrollment, 3 months2
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.
Time frame
at hospital discharge (up to 12 weeks after randomization), immediately post intervention, 5 weeks post intervention, 3 months3
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.
Time frame
at hospital discharge (up to 12 weeks after randomization)4
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.
Time frame
at hospital discharge (up to 12 weeks after randomization), 3 month followupSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Francis Family Foundation
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov