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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce anxiety in individuals who have survived an ICU stay, particularly those who experienced respiratory failure and required a breathing machine for over a day. Participants will engage in a self-management program based on cognitive behavioral therapy, a type of talk therapy that helps change negative thought patterns. The trial compares this program to standard hospital care to determine its effectiveness in reducing anxiety. It targets individuals who are alert, not confused, and experiencing anxiety symptoms. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance anxiety management for ICU survivors.

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 prior data suggests that this intervention is safe for ICU patients?

Research has shown that a self-help program based on cognitive behavioral therapy (CBT) is practical and well-received by patients recovering from severe breathing problems. In earlier studies, patients who used this program during and after their ICU stay found it easy to follow and beneficial. These studies primarily assessed the ease of providing the therapy and patient participation. They identified no major safety issues or negative effects, indicating that the treatment is safe. To date, there have been no concerning reports about the safety of this therapy for patients similar to those in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive behavioral therapy (CBT) based self-management intervention for anxiety in respiratory failure survivors because it empowers patients to actively manage their mental health. Unlike standard care, which often involves medication or traditional therapy sessions, this approach teaches practical skills for managing anxiety, putting control directly in the hands of the patients. This could lead to improved mental health outcomes without the side effects of medication, making it a promising alternative for those who prefer non-pharmacological interventions.

What evidence suggests that this intervention might be an effective treatment for anxiety in ICU patients?

Studies have shown that self-help techniques based on cognitive behavioral therapy (CBT) effectively reduce anxiety in individuals who have survived severe breathing problems. Research indicates that this method is practical and helps manage anxiety, common among those who have experienced respiratory distress. One study found that a six-session program using CBT principles, specifically designed for these patients, improved their anxiety levels. Additionally, CBT has shown promise in treating anxiety in patients with chronic obstructive pulmonary disease (COPD), suggesting it could also benefit those with respiratory failure. This trial will compare a CBT-based self-management intervention for anxiety with usual hospital-based care, offering hope that CBT-based self-help could be a useful tool for managing anxiety in ICU survivors. ^{1 2 3 4 5}

Who Is on the Research Team?

Megan Hosey, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33672672/

A Cognitive Behavioral Therapy-Informed Self ... A Cognitive Behavioral Therapy-Informed Self-Management Program for Acute Respiratory Failure Survivors: A Feasibility Study. J Clin Med ...

2. mdpi.com mdpi.com/2077-0383/10/4/872

A Cognitive Behavioral Therapy-Informed Self ... Self-management in acute respiratory failure (SMARF) is a 6-session intervention which was adapted from existing protocols to improve anxiety in ...

3. researchgate.net researchgate.net/publication/349468524_A_Cognitive_Behavioral_Therapy-Informed_Self-Management_Program_for_Acute_Respiratory_Failure_Survivors_A_Feasibility_Study

(PDF) A Cognitive Behavioral Therapy-Informed Self ... ... Informed Self-Management Program for Acute Respiratory Failure Survivors: A Feasibility Study ... therapy for anxiety in the context of respiratory distress ...

4. withpower.com withpower.com/trial/phase-respiratory-insufficiency-5-2024-dbef2

Self-Management Intervention for Anxiety in Respiratory ... 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 ...

5. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/a-cognitive-behavioral-therapy-informed-self-management-program-f

A cognitive behavioral therapy-informed self-management ... A cognitive behavioral therapy-informed self-management program for acute respiratory failure survivors: A feasibility study. Megan M. Hosey ...