Cognitive Behavioral Therapy for Mechanical Ventilation Wean

NCT04763590 | Completed

• 1 other identifier: 828187
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Cognitive Behavioral Therapy; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving mechanical ventilation and Failed 3 spontaneous breathing trials

You may not qualify if:

• Delirium

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 31327505 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: November 29, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)