Critical Care Anxiety and Long-Term Outcomes Management

Study Overview
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Brief Summary
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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.

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Anxiety Management in the ICU
* Other: Usual Care (UC)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anxiety Management (AM)<br> | Behavioral: Anxiety Management in the ICU<br>* The AM intervention is based on a Cognitive-Behavioral Therapy (CBT) approach, empirically supported in other settings, though we do not know whether this approach will be effective for ICU patients. It will offer all participants core aspects of CBT including: (1) establish rapport/therapeutic alliance; (2) anxiety psychoeducation; (3) normalization of difficulties; (4) establishment of a sense of hope; (5) reflective listening; (6) supportive statements; (7) exposure to anxious thoughts/feelings; (8) directive statements; and (9) provision of coping strategies. It will consist of modules that include the aforementioned core aspects and optional modules based on each participant's anxiety experience and preference.<br>|
| Placebo Comparator: Usual Care (UC)<br> | Other: Usual Care (UC)<br>* The UC group will receive usual care as per the Harborview Medical Center usual care standard. Because this is an effectiveness trial, treatment decisions for UC participants will be left to the discretion of the primary provider and/or primary medical team and may or may not include: (1) referral to rehab psychology C&L service; (2) referral to psychiatry C&L service; or (3) pharmacologic management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety (Visual Analog Scale for Anxiety (VAS-A) | Anxiety at discharge and change in anxiety from baseline to discharge as measured by the 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| Health-Related Quality of Life (as measured by the EQ-5D-5L and SF-36) |  | 3 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, intensive care unit, critical care