Critical Care Anxiety and Long-Term Outcomes Management

Phase 2

Terminated

• Conditions: Anxiety
• Interventions: Behavioral: Anxiety Management in the ICU; Other: Usual Care (UC)

• Registration Number: NCT02421861
• Lead Sponsor: University of Washington

Brief Summary

The aims of this study are to (1) test the benefits of a non-pharmacologic anxiety management approach with patients who are critically ill and/or traumatically injured during intensive care hospitalization and (2) test whether this approach reduces anxiety and improves engagement in rehabilitation therapies, shortens duration of hospitalization, and improves psychological and quality of life outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Primary Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 18 years or older
• Ability to read, write, and speak English
• Alert (Best RASS ICU sedation score ≥-2)
• Current CAM-ICU test negative
• Expected ICU stay ≥48 hours
• Anxiety Visual Analog Scale (VAS-A) score ≥30
• Prescribed rehabilitation therapy at eligibility

Exclusion Criteria

• Inability to communicate (verbally, or via hand writing/gestures)
• Greater than 90% probability of mortality in hospital
• Anticipated discharge to hospice or transition to end-of-life care
• Pre-existing cognitive impairment (e.g., dementia, pervasive developmental disorder)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anxiety Management (AM)	Anxiety Management in the ICU	-
Usual Care (UC)	Usual Care (UC)	-

Primary Outcome Measures

Name	Time	Method
Anxiety (Visual Analog Scale for Anxiety (VAS-A)	Participants will be followed for the duration of hospitalization, an expected average of 13 days and not more than 45 days	Anxiety at discharge and change in anxiety from baseline to discharge as measured by the Visual Analog Scale for Anxiety (VAS-A)

Secondary Outcome Measures

Name	Time	Method
Long-Term Anxiety and Depressive Symptoms (as measured by the Hospital Anxiety and Depression Scale (HADS)	3 months after enrollment as measured by the Hospital Anxiety and Depression Scale (HADS)
Long-Term Posttraumatic Stress Symptoms (as measured by the PCL-5)	3 months after enrollment as measured by the PCL-5
Length of ICU and Hospital Stay	Measured in days (an expected average ICU stay=5 days and average Hospital stay=13 days and not more than 45 days)
Engagement in rehabilitation therapies (As measured by a 2-item engagement questionnaire)	As measured by a 2-item engagement questionnaire (developed specifically for this study) at the time of hospital discharge (i.e., based on an expected average duration of hospitalization of 13 days and not more than 45 days)
Health-Related Quality of Life (as measured by the EQ-5D-5L and SF-36)	3 months after enrollment