AnxietyNCT04763590
Cognitive Behavioral Therapy for Mechanical Ventilation Wean
A study testing Cognitive Behavioral Therapy in people with Anxiety and Cognitive Behavioral Therapy, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Anxiety, Cognitive Behavioral Therapy, Mechanical Ventilation Complication
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 2 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Receiving mechanical ventilation and Failed 3 spontaneous breathing trials
Who cannot join
- Delirium
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start29 Nov 2017
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763590
- Sponsor's protocol ID
- 828187
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31327505
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Mechanical Ventilation Wean
- ClinicalTrials.gov ID
- NCT04763590
- Acronym / sponsor ID
- 828187
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive 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. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving mechanical ventilation and Failed 3 spontaneous breathing trials
Key exclusion criteria (1 listed)
- Delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThis 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Respiratory Anxiety
Time frame: 6 weeks
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.
Panic Symptoms
Time frame: 6 weeks
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).
Generalized Anxiety
Time frame: 6 weeks
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.
Depression
Time frame: 6 weeks
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.
Time spent on tracheostomy-collar (off mechanical ventilation)
Time frame: 6 weeks
Time on tracheostomy collar (TC) was assessed from the beginning of the cognitive behavioral therapy intervention until study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 31327505Cohen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Anxiety and Cognitive Behavioral Therapy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Anxiety (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.