Cognitive Behavioral Therapy for Mechanical Ventilation Wean

The purpose of this study is to use CBT strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

Study Overview

• Status: Completed
• Conditions: Anxiety; Mechanical Ventilation Complication; Cognitive Behavioral Therapy
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

Detailed Description

Approximately a third of patients in intensive care are mechanically ventilated. The current weaning standard of care leaves much to be desired in both patient anxiety and time to wean. Cognitive behavioral therapy (CBT) is the gold standard treatment for anxiety. The purpose of this study is to use CBT strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Receiving mechanical ventilation and Failed 3 spontaneous breathing trials

Exclusion Criteria:

• Delirium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cognitive Behavioral Therapy; Cognitive Behavioral Therapy (CBT) had 3 principal components: (1) psychoeducation, (2) cognitive restructuring, and (3) exposure. In this treatment, derived from an empirically-supported treatment for panic disorder, psychoeducation consisted of teaching about the interrelationship between thoughts, feelings, and physical sensations during weaning. The cognitive component taught patients how to challenge their thoughts, with a particular focus on identifying thoughts that over-estimated the probability of negative medical events. The behavioral component consisted of reducing the need for mechanical ventilation in a step-wise, graduated, manner.

Behavioral: Cognitive Behavioral Therapy; This study focuses on patients who are on a mechanical ventilator and who have been medically cleared to come off of it. The purpose of the study is to learn more about the possible influence of cognitive behavioral therapy in helping patients who are having some trouble getting off of the ventilator. Cognitive behavioral therapy is a highly effective intervention for anxiety and the investigators are evaluating whether cognitive behavioral therapy might be helpful in cases where it is difficult to come off of the ventilator. Cognitive behavioral therapy is experimental for mechanical ventilation assistance as no research to date has evaluated whether it might be helpful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Anxiety	The Anxiety Inventory for Respiratory Disease provides an assessment of anxiety in patient with respiratory disease which is free of the physical symptoms of respiratory disease that often overlap with and confound an accurate assessment of anxiety. A score of 14.5 discriminates between patients with and without anxiety. The measure is reliable, valid, and sensitive to change.	6 weeks
Panic Symptoms	the investigators assessed whether patients experienced the panic symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, when weaning from the ventilator or when anticipating weaning and, if they endorsed the symptom, asked patients to rate symptom severity from 1 to 7 (7 being the worst).	6 weeks
Generalized Anxiety	The investigators assessed generalized anxiety with the Generalized Anxiety Disorder 7 Scale (GAD-7). The minimum score is zero and maximum score is 21. Higher scores represent a worse outcome. A score of 10 on the Generalized Anxiety Disorder 7 represents clinically significant levels of generalized anxiety.	6 weeks
Depression	The investigators assessed depression with the Patient Health Questionnaire 2 (PHQ-2). The scale ranges from zero to 6, with higher scores representing a worse outcome. A score of 3 or higher signifies likely clinical depression.	6 weeks
Time spent on tracheostomy-collar (off mechanical ventilation)	Time on tracheostomy collar (TC) was assessed from the beginning of the cognitive behavioral therapy intervention until study completion.	6 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• Cohen JN, Gopal A, Roberts KJ, Anderson E, Siegel AM. Ventilator-Dependent Patients Successfully Weaned With Cognitive-Behavioral Therapy: A Case Series. Psychosomatics. 2019 Nov-Dec;60(6):612-619. doi: 10.1016/j.psym.2019.02.003. Epub 2019 Feb 12. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 828187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No