Critical Care Anxiety and Long-Term Outcomes Management (CALM)

University of Washington

Status and phase: Terminated; Phase 2

Conditions: Anxiety

Treatments: Other: Usual Care (UC); Behavioral: Anxiety Management in the ICU

Study type: Interventional

Funder types: Other

Identifiers

NCT02421861

48493-G

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 2 patient groups, including a placebo group

Anxiety Management (AM)

Experimental group

Treatment:

Behavioral: Anxiety Management in the ICU

Usual Care (UC)

Placebo Comparator group

Treatment:

Other: Usual Care (UC)