Cognitive Behavioral Therapy for COPD and Emotional Distress

Overseen By Patricia Bamonti, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Antimuscarinics

Disqualifiers: Cognitive impairment, Wheelchair use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining physical exercises with cognitive behavioral therapy (CBT) can benefit Veterans with chronic obstructive pulmonary disease (COPD) who also experience depression or anxiety. The goal is to enhance their physical activity and mental health through an 8-week online program. Veterans diagnosed with COPD who face emotional distress, such as depression or anxiety, and have low physical activity may be suitable candidates. As an unphased trial, this study provides Veterans with a unique opportunity to improve their well-being through innovative, accessible treatment.

Do I need to stop my current medications for this trial?

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 healthcare provider.

What prior data suggests that this intervention is safe for Veterans with COPD and emotional distress?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for people with COPD. Studies have examined its effects on both mental and physical health, and results suggest that COPD patients usually tolerate CBT well.

In these studies, patients did not report any serious side effects directly caused by CBT, indicating that the treatment did not lead to major problems. CBT aims to help manage emotional stress and improve physical activity, which can benefit those with COPD.

Overall, evidence indicates that CBT is a safe option for many people with COPD who are also dealing with emotional stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Step-CBT for COPD and emotional distress because it combines physical activity goals with cognitive behavioral therapy (CBT) in a unique way. Unlike traditional treatments that often focus solely on medication or pulmonary rehabilitation, Step-CBT integrates an 8-week program of personalized step goals and psychological support via weekly video sessions. This dual approach not only addresses physical health but also targets the emotional challenges faced by COPD patients, potentially offering a more holistic improvement in quality of life.

What evidence suggests that Step-CBT might be an effective treatment for COPD and emotional distress?

Research has shown that cognitive behavioral therapy (CBT) benefits people with COPD. Studies have found that CBT reduces anxiety and depression, common in those with COPD. It can also improve quality of life and even aid lung function. One study showed that CBT helped patients adhere better to their treatment plans. Overall, CBT appears promising for addressing both the physical and emotional challenges of COPD. In this trial, participants will receive Step-CBT, an integrative 8-week physical activity and CBT intervention, to further explore its benefits for COPD and emotional distress. ^{1 3 5 6 7}

Who Is on the Research Team?

Patricia Bamonti, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

Veterans over 40 with COPD, experiencing depression or anxiety, and not meeting physical activity guidelines. They must have internet access, be able to attend VA sessions, communicate in English, consent to audio recording and wear a Fitbit. Excluded are those highly active or engaged in other exercise studies, needing walking aids or oxygen for activity.

Inclusion Criteria

Participants with > 90% accuracy of device Fitbit to manual step counts

Agreeable to audio record study session

PA level below recommended national guidelines for older adults or < 150 minutes of PA per week of moderate intensity. This will be measured using the Physical Activity Vital Signs questionnaire (PAVS)

Exclusion Criteria

Average baseline step counts of greater than or equal to 10,000 steps per week

Plans to participate in an exercise-related research study in the next 3 months

I use a cane or walker to help me walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete Step-CBT, an integrative 8-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist via VA Video Connect.

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in depression, anxiety, exercise capacity, and step count.

8 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Step-CBT

Trial Overview

The trial is developing an integrated intervention combining physical activity and mental health support for veterans with COPD who also suffer from emotional distress. Delivered via video connect, it aims to improve both COPD outcomes and mental well-being.

How Is the Trial Designed?

Group I: Step-CBT Experimental Treatment 1 Intervention

Participants will complete Step-CBT, an integrative 8-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist. Sessions will take place once per week for 60 minutes using VA Video Connect. Each session will include core components 1) Reviewing physical activity goals, prescribing new step count goal, and problem-solving barriers and 2) The weekly CBT intervention module.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study involving 30 patients with chronic obstructive pulmonary disease (COPD), those who received psychotherapy as part of their rehabilitation program showed significant reductions in anxiety and depression levels compared to those who did not receive psychotherapy.

Both groups improved their walking distance, but the addition of psychotherapy did not affect this physical performance, highlighting its specific benefit for mental health rather than physical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effect of psychotherapy on anxiety and depression in chronic obstructive pulmonary disease. de Godoy, DV., de Godoy, RF.[2019]

In a nationwide study of Danish COPD outpatients, higher doses of inhaled corticosteroids (ICS) were linked to a dose-dependent increase in the use of antidepressants, indicating a potential psychiatric side effect.

Patients receiving medium to high doses of ICS also showed a significant increase in the risk of psychiatric hospital admissions, suggesting that while ICS are effective for respiratory issues, they may carry risks for mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Use of ICS and Psychiatric Symptoms in Patients with COPD-A Nationwide Cohort Study of 49,500 Patients. Jordan, A., Sivapalan, P., Eklöf, J., et al.[2021]

The proposed model for psychotherapeutic intervention in Chronic Obstructive Pulmonary Disease (COPD) patients focuses on helping them accept their illness and restructure their life goals, which can improve their coping mechanisms.

Family or marital therapy is highlighted as the most effective treatment option, aiming to reduce anxiety, improve compliance with medical regimens, and enhance the patient's control over their emotional and respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The poorly coping COPD patient: a psychotherapeutic perspective. Post, L., Collins, C.[2019]

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]

Cognitive Behavioral Therapy (CBT) and COPD education both significantly improved quality of life, anxiety, and depression in COPD patients over an 8-week period, with effects maintained during follow-up.

The study involved 238 patients with moderate-to-severe anxiety and/or depression, showing that both interventions were equally effective in enhancing well-being without differences in health service usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPD education and cognitive behavioral therapy group treatment for clinically significant symptoms of depression and anxiety in COPD patients: a randomized controlled trial. Kunik, ME., Veazey, C., Cully, JA., et al.[2018]

This study aims to evaluate the effectiveness of cognitive behavioural therapy (CBT) delivered by respiratory nurses for patients with chronic obstructive pulmonary disease (COPD), addressing common co-morbidities like anxiety and depression that can worsen health outcomes.

The trial is a prospective randomized controlled study comparing CBT to self-help leaflets, with primary and secondary outcomes measured at three, six, and twelve months, making it a significant investigation into accessible mental health interventions for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioural therapy (CBT) interventions for anxiety in patients with chronic obstructive pulmonary disease (COPD) undertaken by respiratory nurses: the COPD CBT CARE study: (ISRCTN55206395). Heslop, K., Newton, J., Baker, C., et al.[2022]

Cognitive Behavioral Therapy (CBT) has been shown to provide small but significant improvements in health outcomes for people with Chronic Obstructive Pulmonary Disease (COPD), particularly when high-intensity CBT is compared to usual care, with effect sizes ranging from -0.45 to 0.54.

The review analyzed 33 studies, including 24 controlled trials, and found that while high-intensity CBT interventions were effective, further research is needed to explore the benefits of low-resource-intensity CBT options, especially in settings where comprehensive care is costly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for People with Chronic Obstructive Pulmonary Disease: Rapid Review. Williams, MT., Johnston, KN., Paquet, C.[2021]

A systematic review identified that cognitive behavioural therapy (CBT) combined with exercise and education showed significant reductions in anxiety and depression in COPD patients, particularly noted in one small randomized controlled trial with a large effect size for both conditions.

However, the overall evidence is limited, as only one larger, higher-quality trial showed significant improvement in depression but not anxiety, indicating a need for more robust studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outcomes for COPD patients with mild-to-moderate anxiety and depression: a systematic review of cognitive behavioural therapy. Coventry, PA., Gellatly, JL.[2022]

The TANDEM trial, involving 423 participants with COPD and anxiety or depression, found that a tailored cognitive behavioral intervention did not significantly improve anxiety or depression symptoms compared to usual care after 6 months.

The intervention was associated with a higher mortality rate in the treatment group (5%) compared to the control group (2%), although none of the deaths were linked to the intervention itself, raising concerns about its overall safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial. Taylor, SJC., Sohanpal, R., Steed, L., et al.[2023]

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