Critical Care Anxiety and Long-Term Outcomes Management

NCT ID: NCT02421861

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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.

Conditions

Anxiety

Keywords

anxiety; intensive care unit; critical care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anxiety Management (AM)

Group Type: EXPERIMENTAL

Anxiety Management in the ICU

Intervention Type: BEHAVIORAL

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.

Usual Care (UC)

Group Type: PLACEBO_COMPARATOR

Usual Care (UC)

Intervention Type: OTHER

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.

Interventions

Anxiety Management in the ICU

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: BEHAVIORAL

Usual Care (UC)

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Jutte

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

48493-G

Identifier Type: -

Identifier Source: org_study_id