Self-Management Intervention for Anxiety in Respiratory Failure Survivors

(SMARA Trial)

Overseen By Megan Hosey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive impairment, Major psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients. The main question\[s\] it aims to answer are: * Is this intervention feasible and acceptable in ARF patients? * Is this intervention in the ICU and hospital associated with reduced anxiety symptoms? Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cognitive behavioral therapy based self-management for anxiety in respiratory failure survivors?

Research shows that cognitive behavioral therapy (CBT) is effective in reducing anxiety in patients with chronic obstructive pulmonary disease (COPD), a condition similar to respiratory failure. Nurse-led CBT has been found to be feasible and cost-effective for treating anxiety in COPD patients, suggesting it could also help respiratory failure survivors manage anxiety. ^{1 2 3 4 5}

Is CBT-based self-management for anxiety safe for people with respiratory conditions?

Cognitive behavioral therapy (CBT) based self-management for anxiety has been studied in people with chronic respiratory diseases like COPD and pulmonary hypertension, and it is generally considered safe. There is no specific mention of safety concerns in the studies, suggesting it is well-tolerated in these populations. ^{1 6 7 8 9}

How is CBT-based self-management for anxiety in respiratory failure survivors different from other treatments?

CBT-based self-management is unique because it combines education about symptoms, breathing exercises, and cognitive techniques to help patients manage anxiety, which is particularly beneficial for those with respiratory conditions like COPD. This approach focuses on teaching patients to identify and change negative thought patterns and behaviors, making it different from standard medical treatments that might not address the psychological aspects of anxiety. ^{1 3 4 6 10}

Research Team

Megan Hosey, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for English-speaking adults over 18 who've been on a ventilator for more than a day due to acute respiratory failure (ARF) and are expected to stay in the hospital for over a week. They must be alert, not delirious, and experiencing anxiety symptoms.

Inclusion Criteria

I can speak English and do not have difficulty with speech.

I expect to stay in the hospital for more than 7 days.

I am fully alert and not overly sedated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms

5 weeks

Sessions completed over 5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3 months

3 months

Phone-based follow-up

Treatment Details

Interventions

• Cognitive behavioral therapy based self-management for anxiety

Trial Overview The study tests if cognitive behavioral therapy-based self-management can reduce anxiety in ICU patients with ARF. It compares outcomes of this intervention against usual care immediately after treatment and at three months follow-up.

Participant Groups

Group I: Self-management intervention Experimental Treatment 1 Intervention

Cognitive behavioral therapy based self-management intervention for anxiety

Group II: Usual Care Active Control 1 Intervention

Usual hospital-based care

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Francis Family Foundation

Collaborator

Trials

2

Recruited

90+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Anxiety is significantly more prevalent in patients with chronic obstructive pulmonary disease (COPD) compared to other populations, highlighting the need for targeted interventions.

The review evaluates the efficacy of COPD self-management programs and explores how anxiety symptoms can impact the effectiveness of these programs, suggesting that some self-management goals may benefit or harm anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and self-management behaviour in chronic obstructive pulmonary disease: what has been learned? Dowson, CA., Kuijer, RG., Mulder, RT.[2017]

Nurse-led cognitive behavioral therapy (CBT) is a practical and cost-effective treatment option for managing anxiety in patients with chronic obstructive pulmonary disease (COPD).

This approach demonstrates that trained nurses can effectively deliver psychological interventions, improving patient outcomes in a population that often faces both physical and mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led cognitive behavioural therapy for treatment of anxiety in COPD. Yohannes, AM.[2020]

A study of 80 adult patients with COPD revealed significant disease-related impairments affecting their breathing, recovery, and daily responsibilities, highlighting the need for targeted support.

Patients expressed high levels of illness-related fears, indicating that addressing these fears through tailored information and counseling is crucial for improving self-management strategies in COPD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-management support for patients with chronic obstructive pulmonary disease in ambulatory care--an observational study]. Hörold, M., Landenberger, M.[2015]

Many patients with Chronic Obstructive Pulmonary Disease (COPD) experience anxiety, which negatively impacts their quality of life, highlighting the need for effective treatment options.

Cognitive Behavioral Therapy (CBT) has been shown to be effective in treating anxiety in COPD patients, with specific interventions such as education about symptoms, breathing exercises, and goal-setting recommended for improving their mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of anxiety in COPD with CBT]. Godschalx-Dekker, JA., Mooren, KJM.[2022]

Tailored cognitive-behavioral therapy (CBT) significantly improved symptoms of depression and anxiety in 23 veterans with congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD), with effect sizes of 0.97 and 0.57, respectively, maintained at a 3-month follow-up.

The intervention also led to notable improvements in disease-specific quality of life for both COPD and CHF patients, indicating that modified CBT can effectively address both emotional and physical health challenges in complex cardiopulmonary conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for chronic cardiopulmonary conditions: preliminary outcomes from an open trial. Cully, JA., Stanley, MA., Deswal, A., et al.[2021]

In a feasibility study involving 46 lung cancer survivors, both high-dose and control groups showed significant reductions in anxiety and dyspnea after 12 weeks, indicating potential benefits of device-guided breathing interventions.

Despite these improvements, adherence to the intervention was low, with only 43% of high-dose participants using the device at least once a week, suggesting challenges in maintaining engagement with the breathing intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Anxiety and Dyspnea via Device-Guided Breathing (RELAX): A Multi-Site Feasibility Study in Post-Treatment Lung Cancer Survivors at Community Cancer Clinics (WF-01213). Danhauer, SC., Dressler, EV., Brown, WM., et al.[2023]

A pilot randomized control trial involving 77 adults with pulmonary hypertension showed that a cognitive behavioral self-help intervention significantly reduced anxiety and depression compared to a wait-list control group.

The intervention was well-accepted and safe, with low dropout rates, and changes in unhelpful thoughts and behaviors were identified as key mechanisms that contributed to the improvements in mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-help cognitive behavioural therapy for anxiety in pulmonary hypertension: pilot randomised controlled trial. Rawlings, GH., Beail, N., Armstrong, I., et al.[2022]

Patients with chronic obstructive pulmonary disease (COPD) experience panic disorder at rates up to 10 times higher than the general population, significantly impacting their quality of life and increasing healthcare costs.

The cognitive model of panic anxiety suggests that COPD patients may misinterpret physical symptoms like shortness of breath as catastrophic, leading to panic attacks; cognitive behavior therapy (CBT) shows promise in treating these symptoms, highlighting the need for further research and collaboration between mental health and pulmonary care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panic attacks and panic disorder in chronic obstructive pulmonary disease: a cognitive behavioral perspective. Livermore, N., Sharpe, L., McKenzie, D.[2022]

The Short-Scale Anxiety Sensitivity Index (SSASI) was found to be a reliable and valid tool for assessing anxiety sensitivity in adults with chronic respiratory diseases (CRD), based on a study of 768 participants.

Using the SSASI can help identify CRD patients who may have comorbid anxiety and depression, allowing for better-targeted psychological interventions to improve their overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Properties of the Short Scale Anxiety Sensitivity Index Among Adults with Chronic Respiratory Disease. Clark, HL., Dixon, LJ., Ramachandran, S., et al.[2023]

A minimal home-based psychoeducative intervention significantly reduced anxiety symptoms in patients with advanced COPD, as evidenced by a lower average score on the Hospital Anxiety and Depression scale (HADS-A) compared to usual care, with results maintained at one and three months post-intervention.

The intervention also improved patients' self-management abilities, reflected in higher scores on the Chronic Respiratory Questionnaire (CRQ) domain of mastery, indicating that the intervention not only alleviated anxiety but also enhanced overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a minimal home-based psychoeducative intervention in patients with advanced COPD: A randomised controlled trial. Bove, DG., Lomborg, K., Jensen, AK., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Anxiety and self-management behaviour in chronic obstructive pulmonary disease: what has been learned? [2017]

2. England pubmed.ncbi.nlm.nih.gov

Nurse-led cognitive behavioural therapy for treatment of anxiety in COPD. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

[Self-management support for patients with chronic obstructive pulmonary disease in ambulatory care--an observational study]. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment of anxiety in COPD with CBT]. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for chronic cardiopulmonary conditions: preliminary outcomes from an open trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Reducing Anxiety and Dyspnea via Device-Guided Breathing (RELAX): A Multi-Site Feasibility Study in Post-Treatment Lung Cancer Survivors at Community Cancer Clinics (WF-01213). [2023]

7. England pubmed.ncbi.nlm.nih.gov

Self-help cognitive behavioural therapy for anxiety in pulmonary hypertension: pilot randomised controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Panic attacks and panic disorder in chronic obstructive pulmonary disease: a cognitive behavioral perspective. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Psychometric Properties of the Short Scale Anxiety Sensitivity Index Among Adults with Chronic Respiratory Disease. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of a minimal home-based psychoeducative intervention in patients with advanced COPD: A randomised controlled trial. [2018]