Cognitive Behavioral Therapy for COPD and Emotional Distress

Overseen by Patricia Bamonti, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must be taking: Antimuscarinics

Disqualifiers: Cognitive impairment, Wheelchair use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic Obstructive Pulmonary Disease (COPD) is prevalent and debilitating chronic disease in Veterans. COPD is highly co-morbid with depression and anxiety conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms ("emotional distress") despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for Veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among Veterans with substantial barriers to hospital-based outpatient care.

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 data supports the effectiveness of the treatment Step-CBT for COPD and emotional distress?

Research shows that cognitive behavioral therapy (CBT) can help people with COPD by reducing anxiety and depression, improving quality of life, and increasing exercise capacity. Studies found that CBT led to small but significant improvements in these areas compared to usual care. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for people with COPD?

Cognitive Behavioral Therapy (CBT) is generally considered safe for people with COPD, as it has been used in various studies without significant safety concerns. It is a psychological treatment that helps manage anxiety and depression, and no major side effects have been reported in the context of COPD. ^{1 3 4 5 6}

How does the Step-CBT treatment for COPD and emotional distress differ from other treatments?

Step-CBT is unique because it combines cognitive behavioral therapy (CBT) techniques specifically tailored for COPD patients, such as education about symptoms and breathing exercises, with strategies to manage anxiety and depression, which are common in these patients. This approach is different from standard COPD treatments that primarily focus on physical symptoms and may not address the psychological aspects. ^{1 5 7 8 9}

Research Team

Patricia Bamonti, PhD

Principal Investigator

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

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Step-CBT (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for People with Chronic Obstructive Pulmonary Disease: Rapid Review. [2021]

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

The poorly coping COPD patient: a psychotherapeutic perspective. [2019]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial. [2023]

5. England 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. [2018]

6. Switzerland 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

9. England 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). [2022]