protocolSection identificationModule nctId: NCT06341972, orgStudyIdInfo id: IRB00247005, secondaryIdInfos id: K23HL155735, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL155735, briefTitle: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention, acronym: SMARA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Francis Family Foundation, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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., conditionsModule conditions: Respiratory Failure, conditions: Anxiety, conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pilot randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive behavioral therapy based self-management for anxiety, outcomesModule primaryOutcomes measure: Treatment Satisfaction Questionnaire, primaryOutcomes measure: average accrual rate of 2 patients/month across all patients, primaryOutcomes measure: treatment feasibility as assessed by sessions completed, primaryOutcomes measure: treatment feasibility as assessed by drop out rate, secondaryOutcomes measure: Visual Analog Scale - Anxiety, secondaryOutcomes measure: State Anxiety Inventory, secondaryOutcomes measure: Hopkins Rehab Engagement Scale, secondaryOutcomes measure: Self Efficacy for Managing Chronic Disease Rating Scale, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Quality of Life as assessed by the European Quality of Life Scale (EQ-5D), secondaryOutcomes measure: Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6, secondaryOutcomes measure: Healthcare Utilization as assessed by Healthcare Utilization interview, secondaryOutcomes measure: Montreal Cognitive Assessment - Blind, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False