Critical Care Anxiety and Long-Term Outcomes Management (CALM)
Primary Purpose
Anxiety
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anxiety Management in the ICU
Usual Care (UC)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety, intensive care unit, critical care
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anxiety Management (AM)
Usual Care (UC)
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Engagement in rehabilitation therapies (As measured by a 2-item engagement questionnaire)
Length of ICU and Hospital Stay
Long-Term Anxiety and Depressive Symptoms (as measured by the Hospital Anxiety and Depression Scale (HADS)
Long-Term Posttraumatic Stress Symptoms (as measured by the PCL-5)
Health-Related Quality of Life (as measured by the EQ-5D-5L and SF-36)
Full Information
NCT ID
NCT02421861
First Posted
April 10, 2015
Last Updated
October 28, 2016
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02421861
Brief Title
Critical Care Anxiety and Long-Term Outcomes Management
Acronym
CALM
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, intensive care unit, critical care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anxiety Management (AM)
Arm Type
Experimental
Arm Title
Usual Care (UC)
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Management in the ICU
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care (UC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety (Visual Analog Scale for Anxiety (VAS-A)
Description
Anxiety at discharge and change in anxiety from baseline to discharge as measured by the Visual Analog Scale for Anxiety (VAS-A)
Time Frame
Participants will be followed for the duration of hospitalization, an expected average of 13 days and not more than 45 days
Secondary Outcome Measure Information:
Title
Engagement in rehabilitation therapies (As measured by a 2-item engagement questionnaire)
Time Frame
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)
Title
Length of ICU and Hospital Stay
Time Frame
Measured in days (an expected average ICU stay=5 days and average Hospital stay=13 days and not more than 45 days)
Title
Long-Term Anxiety and Depressive Symptoms (as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame
3 months after enrollment as measured by the Hospital Anxiety and Depression Scale (HADS)
Title
Long-Term Posttraumatic Stress Symptoms (as measured by the PCL-5)
Time Frame
3 months after enrollment as measured by the PCL-5
Title
Health-Related Quality of Life (as measured by the EQ-5D-5L and SF-36)
Time Frame
3 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Learn more about this trial
Critical Care Anxiety and Long-Term Outcomes Management
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