search
Back to results

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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, intensive care unit, critical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 10, 2015
    Last Updated
    October 28, 2016
    Sponsor
    University of Washington
    search

    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

    We'll reach out to this number within 24 hrs